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Quality Training Seminars and Classes

From Jack Quinn Solutions, L. L.C

CPSM Certification Coaching Online Course - ...btaining a CPSM certification told the world that I was a quality supply chain leader, which is a significant achievement for anyone in supply chain management. For that reason I was determined not only to help myself, but help others, demonstrate professional skills with a CPSM Certification Course. Benefits People who register for CPSM Certification Coaching realize these benefits: more...

From QLogy Management Services Pvt. Ltd

ITIL V3 Foundation Training in INR 2000

QLogy Offers ITIL V3F eLearning with 100% Passing Warranty....Pay just INR 2000 + 10. 3% S. T... If you are already ITIL V3 Foundation Certified go for ITIL Advance module. We are the only Company in INDIA to provide all the ITIL INTERMEDIATE MODULES. We provide TWENTY Sample papers, but you can pass by solving just SEVEN, Quality of eLearning can be judged by listening to FREE sample more...

From Sql Server Online Training

T-SQL and SQL Server DBA Online Training

...ses] is also provided after the course. We assure you quality of training along with Study Material for reference including Practice Material. If you are looking for SQL DBA Online Trainings or Projects, you can contact us. *ALL OUR SESSIONS ARE COMPLETELY PRACTICAL* For Free Demo and fee details and course structure, you can reach us anytime at: SQL School more...

MSBI SSIS SSAS SSRS Online Training SQL School ... Real Time Projects. We are committed to deliver trusted, quality trainings on MSBI ( SSIS, SSAS & SSRS ) for working SQL Developers and DBAs. All concepts (including clustering) will be discussed practically. NO PPTs or SCREENSHOTS during the live sessions. We will provide the material and FAQs separately. Features of our Real time Training includes: 1. Study Material 2. Real Time more...

BEST PRACTICAL SQL DBA REALTIME ONLINE TRAINING PRACTICAL SQL SCHOOL

...ses] is also provided after the course. We assure you quality of training along with Study Material for reference including Practice Material. If you are looking for SQL DBA Online Trainings & Projects (REGULAR or WEEKENDS), you can contact us. *ALL OUR SESSIONS ARE COMPLETELY PRACTICAL* For Free Demo and fee details and course structure, you can reach us anytime at: SQL School more...

MSBI Training

SQL School is a pioneer in SQL Server specific trainings with quality and realtime oriented programs. We offer MSBI Trainings on industry lines with THREE realtime projects. We discuss the following module: SQL Server Integration Services SQL Server Analysis Services SQL Server Reporting Services Duration of the total course is for 75 hours. We assure you the quality and interactive more...

SQL DBA Online Trainings with Case Studies

Realtime SQL Server and DBA Online Training is provided with LIVE databases and Case Studies. SQL SERVER Administration [SQL DBA] Course Contents: SQL Server basics and T-SQL: SQL Server Design Architecture Database Design and Table Design Principles Compression Techniques and Capacity Planning Data Integrity & Consistency Views and Data Security JOINS and Sub Queries and Query more...

From Kepner-Tregoe Inc

Live Webcast Thinking Correctly Under Pressure

Thinking Correctly Under Pressure (TCUP) continues to gain more and more attention in companies that are committed to the idea of Service Excellence. The ability to "stay cool and focused" when the situation at hand gets hot is something that is required whenever we look at Incident Management, but could also be transferred into any other environment where effective decision making and proactive more...

From Requirements Solutions Group

How to Define and Document Use Cases

...and where to put what information is critical to creating quality functional requirements. Without a common understanding of the purpose and structure of use case diagrams and the business use case document, use cases can quickly become "useless cases". This training workshop offers use case training in the basics of use case documentation and business use case diagrams as tools for business more...

How to Manage Changing Requirements

Managing requirements change has been a major challenge even for the best-run projects. Keeping track of how the changing business environment impacts ongoing projects and production applications can be a nightmare without proper tools and techniques. The concept of requirements management is not new but with an increase in the use of off-shore developers and off-the-shelf solutions, it has become more...

From Sql Server Online Training

SQL DBA Training

SQL School offers real time orientation training for SQL Server DBA course on 2005 and 2008 versions. Course includes the indeapth discussion of all the administration concepts with practical scenarios. Duration of the sessions is for about 80 hours. We assure you the quality of training and you can contact us always for your doubts in the subject any time. 100 % placement assistance more...

From TDM Webacademy

E103-5 Organizational Structure and Management Plan

The foundation of the success of a business is the quality of the people that works there. For this reason, particular attention must be paid to your organization structure and the key players that manage the day to day operations. This webinar provides an analysis of a business organizational structure, including principle or key employees and identifies strategies needed to develop a more...

From Spectralight Images, LLC

3DS MAX Online - Rendering with Mental Ray

For most forms of animation, rendering an image the the most critical step in the process. This online course will take you through the various options available when using Mental Ray to render in 3DS MAX & Design 2010. You will learn about the options available for optimizing render time and image quality, using indirect illumination and working with several new features available in release more...

From Kogent

BOI300 - BusinessObjects Data Integrator XI 3x - Core Concepts - Virtual Session BOI300: BusinessObjects Data Integrator XI 3x - Core Concepts - Virtual Session BusinessObjects Data Integrator XI 3. 0 enables you to integrate disparate data sources to deliver more timely and accurate data that end users in an organization can trust. In this three-day course, you will learn about creating, executing, and troubleshooting batch jobs, using functions, scripts and transforms more...

From Rich Hessler Solar Sales Training

Free Solar Webinar

...photovoltaic solar panel systems. A solar system offers a quality investment with a 10-16% risk and tax free return on investment (with current rebates). This means the solar solar system will pay for itself within 6-10 years and continue generating electricity for the life of the home. Finding and selecting a quality solar contractor to install the solar system for a fair price and to more...

From Future Media Concepts

Avid Media Composer Effects Techniques v35 - Online 2 days Students learn to design multilayered and multi-nested effects on Avid Media Composer for maximum quality and optimal render time. Hands-on exercises help students create and combine effects to achieve real-world results. more...

From Internet English Learn Online

Internet English Learn Online Custom Course If for any reason none of the English courses offered on this website suit exactly what you want, then please don't hesitate to contact us. IELO is committed to ensuring only the highest quality of teaching in our English lessons and we are dedicated to satisfying every student's individual needs. Our experienced course developers will be more than happy to work with you to give you the English more...

From The College of Call Center Excellence

Call Center Quality Assurance Certification - Live Online - September 5-7 2012

Build a Best-in-Class Customer Service Center with Quality Assurance Monitoring Training. The quality assurance workshop provides participants with an understanding of the elements that are crucial in building a well-planned program that meets the strategic needs of the organization. Those goals and/ or needs may be orientated toward Cost, Service, Sales or Marketing. more...

Call Center Quality Assurance Certification - Live Online - June 6-8 2012

Call Center Quality Assurance Certification - Live Online - March 7-9 2012

From HR Learning Center LLC

HIRING DOS AND DONTS This one-hour on-line live interactive webinar will provide managers with top tips to avoid liability when hiring employees. Learn what questions you can and cannot ask during the interview process. Learn how to avoid asking questions that can lead to discrimination claims later on. Also, learn what employment-at-will really means and how to avoid losing your right to hire or fire at-will. more...

From Webucator

Customer Service Training ...omers, interpret non-verbal communication skills, provide quality customer service over the telephone, and communicate effectively through e-mail. This customer service class by teaching how to determine what customers want, and evaluate the service provided. Students will also learn how to create, implement, and monitor service standards. Course activities also cover conducting interviews, more...

Customer Service over the Telephone This customer service training class teaches telephone courtesy and service. In this class, students will learn to provide high quality customer service over the telephone by improving their listening and questioning skills to clarify customer needs. Students will learn to create action plans to improve their customer service telephone skills so that they can provide excellent customer service more...

Introduction to QuarkXPress 7 Training ...g class, you ' ll use QuarkXPress to lay out professional quality single and multiple-page documents that include text and graphics, and are designed for professional printing and publication. You have probably created simple documents, such as letters and reports, using word processing applications. You most likely applied basic type formatting, included some graphics in the documents, and more...

MOC 8824 - Sales Order Processing in Microsoft Dynamics GP 10.0 ...perform additional functions setting up process holds for quality assurance and linking order documents to purchase orders.A thorough understanding of these topics allows you to boost sales order processing productivity and help improve customer service by automating sales order workflow procedures. Microsoft Dynamics GP Sales Order Processing gives you precise control over the flow of sales more...

MOC 8885 - Human Resources in Microsoft Dynamics GP 10.0 This Microsoft Dynamics GP Human Resources training class provides you with an in-depth view of the extensive functionality contained within the Human Resources application. Besides learning the functionality, you will also learn tips and techniques that can help make an implementation successful, and you will gain a thorough understanding of the HR application and its capabilities.The HR class more...

MOC 8399 - FRx 6.7 Report Design Essentials I ... you need to create, maintain and distribute presentation quality reports using Microsoft FRx. The class also includes coverage of additional functionality designed to help you create new reports, and distribute and analyze your company ' s financial information. You learn about basic foundational skills, complex calculations, drag and drop reorganization, rounding adjustments and account more...

Introduction to Crystal Reports 2008 Training

This Crystal Reports training class is designed for new users of Crystal Reports 2008. Some of the topics covered include a review of the software features, report design and the creation of presentation quality reports. Students get practical experience through plenty of hands-on exercises. more...

Business Problem Solving and Strategic Decision Making This Business Problem Solving training course teaches students the fundamentals of solving business problems. This course introduces students to the need for problem solving, ineffective responses to problems, the elements of an effective solution, and the skills needed for effective problem solving. Students will also learn how to avoid inappropriate responses to problems, identify types of more...

Strategic Decision Making Training This Strategic Decision Making training course teaches students how to plan, frame, and research decisions. Students learn how to define decisions, apply appropriate decisions frames, avoid overconfidence, deal with uncertainty, generate options and select the best one, develop numerous high-quality options, evaluate the options and make a final choice, review and learn from experience, identify more...

From Manufacturing Executive Institute

Better Methods To Control Tools Fixtures in Production ... explore some specific techniques for better managing the quality and availability of tools and fixtures. We will review tool and fixture maintenance requirements, including an innovative technique for scheduling and integrating tool and fixture preventive maintenance activities into production processes. We will also explore outsourcing opportunities in tool management and present some more...

How to Dramatically Improve the Quality of Your Shipment ForecastsTechniques to Improve Forecast Inputs Supply-chain professionals must NEVER stop thinking about the integrity of the shipment forecast. This is because a shipment forecast represents independent demand for company product which in turn drives the Master Production Schedule (MPS) process. Start with an inaccurate shipment forecast and a poor performing MPS is sure to follow. Continue with a poor forecasting process and inventory will more...

The Most Important Metrics For Measuring Supply Chain Performance ...rchase Order Cycle Time a Fill Ratea the rate or quality of completing a required or set of required activities. Common fill rate metrics include: a Line Count Fill Rate a SKU Fill Rate a Case Fill Rate a Value Fill Rate These supply chain metrics, PLUS a few new metrics (like DPMO: Defects per Million Opportunities) brought to us by the Six-Sigma world, will be more...

How to Factually Evaluate Critical Supplier Performance and Risks ...ry reliability, total material cost and received material quality. GDI's Comprehensive Supplier Performance & Risk Assessments provide manufacturing & distribution companies with a proactive mechanism to evaluate and grade their most important suppliers. This in turn will help them negotiate better pricing and improved terms & conditions. The end result will be reduced total spending, more...

How to Achieve Maintain ERP Systems Master File Data Integrity ...ss much the same way pollsters and scientists measure the quality of data going into their political polls and scientific experiments. Specifically, this important webinar focuses on the following THREE critical issues that can ultimately determine the effectiveness of an integrated information systems environment: 1. How to measure, monitor and report the completeness of master file more...

A Case for Routine Use of Statistical Process Control SPC in Manufacturing You are invited to attend the Manufacturing Executive Institutea ™s FREE February 2011 3rd Thursday - a Operations Improvement webinar, A Case for Routine Use of Statistical Process Control (SPC) in Manufacturing. Statistical Process Control is a term that describes a process for predicting failures and methodically determining the underlying cause(s) before the predicted failures can more...

From GlobalCompliancePanel

ISO 13485 as a Quality Management System for Medical Devices - Webinar GlobalCompliancePanel This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. Thursday, February 16, 2012 10: 00 AM PST | 01: 00 PM EST more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine Overview: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Tuesday, February 14, 2012 10: 00 AM PST | 01: 00 PM EST more...

Statistics in Quality Control - Critical decisions-Risks Basics - Webinar By GlobalCompliancePanel Statistical Applications includes topics related to basic statistical applications and advanced statistical applications such as statistical process controls (SPC). Includes elements of central tendency, dispersion, proportions and percentages, probability, capability, control limits, specifications limits and more. Thursday, January 12, 2012 10: 00 AM PST | 01: 00 PM EST more...

Risk Management in IEC 60601-1 Third Edition - Webinar By GlobalCompliancePanel IEC 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology. This new philosophy has been difficult for test houses and compliance bodies to absorb and develop test strategies. Currently, the EU and Canada have announced May 31-June 1, 2012 as the date when the Second Edition will be more...

HIPAA Security Rule Compliance When Communicating with Patients Using Mobile Devices - Webinar By mentorhealth The session will discuss the requirements, the risks, and the issues of the increasing use of mobile devices for patient communications and provide a road map for how to use them safely and effectively, to increase the quality of health care and patient satisfaction. Tuesday, November 29, 2011 10: 00 AM PST | 01: 00 PM EST more...

The Controls for Outsourcing Manufacturing and Testing - Webinar GlobalCompliancePanel ...ar will begin with a brief review about the importance of quality systems and their role in maintaining the organization. Outsourcing will be defined and examples throughout the FDA regulated industry will be discussed. Of course, regulatory requirements will be discussed to include the FDA's current thinking about the required controls. Particular emphasis will be given on the importance of more...

Pharmaceutical and Medical Device Good Manufacturing Practices - Similarities and Differences - Webinar By GlobalCompliancePanel ...tween these GMPs as well as show how they relate to other quality systems, regional regulations, and guidance documents. Examples include ICH, GHTF, ISO particularly ISO 13485 as well as European quality requirements. The considerable use of graphical techniques will enhance this learning experience. Questions are strongly encouraged. Price List: Live : $245. 00 Corporate live : $995. 00 more...

Working with the Pharmacopeias and Compendia - Webinar By GlobalCompliancePanel ...unction that the pharmacopeias play in the regulation and quality control of pharmaceutical products. The pharmacopeias play a key role in setting standards for individual pharmaceutical products. These standards are both for the physico-chemical properties of pharmaceuticals and for the methods used in the testing of these products. While the pharmacopeias are important for setting standards more...

From OneSource Professional Training Solutions, Inc

ITIL v3 Service Operation Virtual Instructor Led

This five-day Live Instructor-Led online course provides you with an intense and focused exploration of the new and updated topics in ITIL ® v3 from the point of view of the owner of a process or set of activities. The course is intended for those who work within a Service Operation (SO) environment and require a deeper understanding of the underlying concepts, processes/ functions and more...

From GlobalCompliancePanel

Effective Internal Auditing-Making Quality Systems More Efficient for the Medical Products Industry - Webinar By GlobalComplianc The different types of internal audits and how they are approached will be discussed. The Internal Audit Lifecycle will be followed from beginning to end. It will be shown that. Internal audits are not simple exercises to determine compliance to some regulatory standards. Instead, the focus must be on auditing the company's quality system to determine if they are meeting their objectives and are more...

Hybrid Quality Systems For Pharmaceuticals - Combining ICH Q7A Part 210-211 - Webinar By GlobalCompliancePanel The manufacture of drugs is controlled by ICH-Q7A and 21 CFR Part 210 & 211. Although these standards were written 24 years apart, they complement each other in many ways. Thursday, September 29, 2011 10: 00 AM PDT | 01: 00 PM EDT more...

From OneSource Professional Training Solutions, Inc

ITIL V3 Foundation

This four-day Live Instructor-Led online course provides you with an intense and focused exploration of the new and updated topics in ITIL ® v3. The course is intended for those who work within IT or wish to explore IT service management frameworks and how they may be used to enhance overall service quality and service provision. more...

From GlobalCompliancePanel

Implementing a Quality Systems-Based Approach to GCP Compliance - Webinar By GlobalCompliancePanel Ensuring GCP quality has often been approached from the perspective of reviewing as many documents as possible, looking for errors and following up on corrections or making "notes to file." In order to design, implement, and maintain GCP compliance in an effective manner, a Quality Systems Approach should be adopted. more...

From ZaranTech.com

Business Analyst Competency Development Program

...with one goal in mind a develop and deliver the highest quality consultants to our Clients and customer. As a consulting company, we help organizations to work smarter and grow faster. We consult with our clients to build effective organizations, innovate & grow, reduce costs, manage risk & regulation and leverage talent. Who should attend? a Entry-level IT Business Analysts a Non IT more...

From GlobalCompliancePanel

Designing Drafting Writing and Implementing The Quality Manual ...quality then begin to explore how quality manuals have evolved into a communications device that assists all functions to reach their goals and objectives. It will demonstrate that the quality manual represents system for working together to achieve the organization's goals. You'll be shown that a quality system exceeds compliance requirements without question. As mentioned above, it can be more...

Establishing a Reduced Testing Program for Pharmaceutical Medical Device Components Reduced testing test permits a medical product manufacturer to reduce testing of incoming components provided there are adequate controls on specification control, material qualification, supplier qualification & monitoring, material validation, and collaborative testing. Industry practice in the performance of reduced testing has resulted in new and modified expectations and requirements. more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...ar will address software that is supporting the company's Quality System and cGMP documentation. It will assist in evaluating software vendor claims to separate compliant software from "vaporware". A manufacturer is responsible to identify these requirements and implement them into an effective 21 CFR Part 11 CGMP software V&V process. Why you should attend: Software has become pervasive more...

Effective Hazard Analysis to meet FDA and ISO134852003 Risk Management Requirements - webinar by global compliance panel FDA-GMPs, known as Quality System Regulations (QSRs), and ISO 13485 require Risk Management as integral part of the development life cycle. more...

FDA Inspections - Dos Donts - webinars by gcp The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. more...

Design Planning and Conducting Effective Audits - Webinars by gcp Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and also be a source of improvement. more...

FDA Inspections - Dos Donts The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. more...

Design Planning and Conducting Effective Audits by gcp Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and also be a source of improvement. more...

Good Deviation Practice what you need to know-BY GCP This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/ CAPA system and thorough investigations more...

Statistical Concepts of Process Validation BY GCP The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". more...

Device Master Record Device History Record BY GCP The FDA's Quality System Regulation (QSR) requires each device manufacturer to compile the specifications and procedures for a medical device. more...

Preventing Food Safety Problems BY GCP Most industries have become reasonably sophisticated in terms of applying the principals and tools involved in quality control and improvement. more...

This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. more...

Root Cause Analysis and Documentation Requirements for CAPA - Webinar By GlobalCompliancePanel RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur. This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters. Emphasis will be placed on realizing system interactions and cultural more...

The Controls for Outsourcing Manufacturing and Testing - Webinar By GlobalCompliancePanel ...sting" explores the use of outsourcing and how it impacts quality and compliance and the organization as a whole. The primary stakeholders and outsourcing include Quality, Research, Production, Laboratories, Purchasing/ Procurement, Finance, and Senior Management. This webinar will study the outsourcing lifecycle and its impact on the organization. Although outsourcing as a whole will be more...

How to Create Configure and Manage a Design Inputs - Design Outputs Traceability Matrix utilizing the principles of Lean Documen Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to avoiding these errors, while more...

Creation and management of a Controlled Document System for a Life Sciences manufacturing plant utilizing the principles of Lean ...ocuments are one of the foundational building blocks of a Quality Management System (QMS) for regulated industries. Too often, controlled documents are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to this key part of a QMS. Why you more...

ISO 13485 as a Quality Management System for Medical Devices by GlobalCompliancePanel ...lp you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: more...

Creation and configuration of a Equipment Facilities and Preventive Maintenance System utilizing the principles of Lean Document Proper preventive maintenance and management of process equipment, and facilities is the foundation for any manufacturing process, including many processes not typically thought of as manufacturing. more...

Creation of DHFs DMRs and DHRs utilizing the principles of Lean Documents and Lean Configuration by GlobalCompliancePanel Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. This webinar applies the Theory of Lean Documents and also more...

Creation of DHFs DMRs and DHRs utilizing the principles of Lean Documents and Lean Configuration - by GlobalCompliancePanel Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. This webinar applies the Theory of Lean Documents and also more...

Failure Mode Effects Analysis FMEA - The Tool of Choice to Improve Product and Process Reliability and Efficiency While Reducin ...ts Analysis is a tried an proven technique to improve the quality, reliability and safety of products and processes in a proactive manner. It has been used successfully for over 60 years in very type of industry and in all stages of product development, process improvement projects. It helps to increase customer satisfaction, by proactively addressing failures that keep us from meeting more...

The 510k Submission Requirements Contents and Options - Webinar by GlobalCompliancePanel Overview: This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish more...

Understanding and Implementing FDAs 21 CFR Part 11 - Webinar By GlobalCompliancePanel In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even though the rule is more than 10 years old more...

The Risk to Subject Safety of Not Accurately Reporting Adverse Events - How to Assess and report AEs and SAEs - Webinar By Globa The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. more...

Introduction to Risk Management - Webinar by GlobalCompliancePanel

This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend. Regardless of job titles, risk management is a shared responsibility by all managers. Compared to accounting, risk is an immature discipline with a variety of risk frameworks competing to dominate. Based on the new Wiley and Sons book, Essentials of Risk more...

Introduction to Master Validation Plans - Webinar By GlobalCompliancePanel

This webinar provides an introduction to the creation, implementation, and maintenance of Validation Master Plans. Key benefits of this seminar include: Achieve satisfactory inspections more easily. Higher assurance of new medical product approvals. Minimize nonconformances. Reduce rates of batch rework and rejections. Avoid product recalls. Take a holistic more...

Water System Design Start-Up and Validation - Webinar By GlobalCompliancePanel This webinar provides a thorough examination of water systems. We will explore the typical components used in water systems and how these components are combined to achieve intended water quality specifications more...

Effective Risk Based Approach to Auditing and Qualifying Suppliers and Vendors - Webinar By GlobalCompliancePanel This webinar will demonstrate how to implement an effective audit program. Regulatory agencies hold firms responsible for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors play a key role in accomplishing these mandates and it is the firm's responsibility to make sure vendors/ suppliers are meeting specifications for the supplied more...

Product Recalls - Planning and Conducting Food Recall - Webinar By GlobalCompliancePanel Creating an effective Product recall process that will protect both the consumer and company's/ brand's reputation requires careful planning and active involvement of each involved department. more...

Webinar on Specification Development - By GlobalCompliancePanel A good specification not only defines the product and process being purchased by the customer, but also serves as an extension of the purchasing contract. more...

Understanding good Closed Loop CAPA system - Webinar By GlobalCompliancePanel This webinar will present how organizations can pursue continual improvements and address the concerns of non-conformances and develop corrective/ preventive actions to prevent the repetition of these occurrences in the future. Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to take a proactive and automated approach to their more...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc Overview: In this session we will discuss the HIPAA audit and enforcement processes and how they apply to covered entities and business associates. We will explain the enforcement regulations and their recent changes that increase fines and create new penalty levels, including new penalties for willful neglect of compliance that begin at $10, 000. We will discuss what information and more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel Overview: Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory personnel need to be informed of these requirements, recognize their significance to their job more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/ DD requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel Overview: If you handle any electronic patient information, dona ™t miss this teleconference on compliance with the extensive requirements for policies and procedures in the HIPAA security regulation. Electronic patient information is everywhere; not only is electronic protected health information in the obvious places such as practice management systems and electronic medical records, but more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance Overview: In this session, attendees will learn what the PCI DSS requires for protection and how the PCI DSS relates to the HIPAA Security Rule - there are substantial similarities, and being prepared for one helps you prepare for the other, as well as for other requirements, such as breach notification. We will discuss how the regulations and standards work and their legal basis, as well as more...

Information Security Risk Analysis Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePane Overview: This session will present the background of the regulations that call for information security risk analysis and show how it fits in to an overall information security management process. The risk analysis process will be presented within the context of the overall risk prioritization and risk mitigation process, using an example. The Information Security Risk Analysis Process more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ...ance with the Regs and Good Clinical Practice will ensure quality data, speed up the review process, and decreases the costs to sponsors. This Webinar addresses the obligations of sponsors, monitors, and investigators who conduct and verify clinical research that is governed by US FDA regulations and ICH guidelines. Why Should You Attend: All CROa ™s, Sites, and Sponsors of Clinical more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ...IQ/ OQ and validation and its role in maintaining product quality * Roles and responsibilities in the validation process * The process validation lifecycle from design to product discontinuation * How about Process Analytical Technology (PAT) * Similarities and Differences-Product and Process Design * Similarities and Differences-Equipment and Facilities * more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel ... and drug product firms. Reducing risk and protecting the quality of a Drug Product (DP) is critical to the DP firm's success. The webinar will focus on the Q7 and FDA GMP requirements, what are the key contractual requirements and what should be negotiated and documented within quality agreements with a CMO firm. Why Should You Attend: Attending this webinar will help you identify what you more...

Designing a CAPA System that Meets and Exceeds Regulatory Requirements - Webinar By GlobalCompliancePanel ...Quality subsystem in any Quality system. Most of the warning letters written by the FDA in 2010 were CAPA relate. Avoiding FDA CAPA findings starts with the design of a robust CAPA SYSTEM. The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical, moral, and legal expectations more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...ct * In Production and Test Equipment and * The Quality System A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process. Why Should You Attend: Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? How can line operators' brains be engaged by the use of such simple yet powerful tools? Use RCA to facilitate a closed-loop problem resolution system to reduce a fire fightinga and minimize compliance problems. Why Should You Attend: more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different more...

Recalls Vigilance - When to Report Complaints - Webinar By GlobalCompliancePanel Overview: This webinar will acquaint one with the lessons learned from over 30 years of adverse events and complaints. FDA has issued warning letters for failing to properly evaluate medical device complaints for reporting under 803 & 806 regulations. Vigilance reporting is also required in Canada, the European Union and many other countries. Warning letters and recalls are posted on FDA's more...

FMEA and Risk Management for Medical Devices - Webinar By GlobalCompliancePanel Overview: This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture. FMEA (Failure Mode & Effects Analysis) is only a segment of Risk Management, but quite valuable for assessing Risk as part of Risk Management. Now that EN 1441 more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel Overview: 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries. Why Should You Attend: More and more organizations are striving to "go green" and develop "sustainable" organization's strategies, which almost always includes using more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel verview: This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. This presentation will describe a proven process for preparing a site for inspection of systems. more...

Key Factors to Write an Effective Standard Operating Procedure SOP and Work Instructions WIs - Webinar By GlobalCompliancePanel Overview: This webinar is designed to outline the characteristic of an effective work instruction, and Standard operating procedure. The webinar is also designed to help differentiate Work Instructions from Standard operating procedures. Attendees will learn the steps used to write effective work instructions and Standard operating procedures. Why Should You Attend: The current shift in FDA more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the different records. Are you maintaining adequate DHF, DMR, DHR, and TF records? Do more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ...int handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...y of software used in manufacturing, devices, design, and quality systems. FDA has cited numerous companies on software verification and validation issues in Warning Letters and inspectional observations. The presentation will address some common sense approach to this dilemma without going overboard; such as having V&V plans and processes that clearly define the completion criteria for a more...

How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel ...for the firm's device history records is compliant to the Quality System regulation, yet when the FDA comes calling, FDA 483 DHR cites are written and warning letters, seizures or worse ensue. Internal Audits show the production controls system compliant, yet again FDA writes the firm up. This webinar will review the production records regulations; with an emphasis on just what is it that more...

Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel Overview: Data Security Analysis for Healthcare Providers: The "meaningful use" rules relating to the adoption of Electronic Medical Records require regular assessment of data security risks. HIPAA re-contains similar requirements. However, many healthcare providers fail to take the necessary steps to analyze their security risks or assess their vulnerabilities. This presentation would address more...

Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel ...ware. Cloud computing is cheaper in the long run, but the quality of validation does not have to be affected by this price cut. Vendors can provide validated systems that can be configured by the client and the client can leverage the validation effort performed by the vendor, which will also provide a cost savings to the client. This webinar will dispel these fears and give you the confidence more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...the number of samples you will take. The average outgoing quality (AOQ) helps you foresee the results if you inspect rejected lots. The average total inspected (ATI) helps you calculate how many items you will inspect including rejected lots. Users of Z1. 4 will want to understand how to set up sampling and select parameters such as AQL and Level. The course provides a complete description of more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel ...quirements can have devastating effects on your company's quality system, including production and manufacturing controls. The purpose of this webinar is to provide attendees with the mandatory compliance requirements for the master production records. Applicable areas may include clinical, technology transfer, and routine manufacturing and packaging for the API and finished commercial product. more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel Overview: As anyone that has been involved in a traditional paper-based validation project can attest to the ability to manage the validation deliverables, timelines, resources, tasks and the compliance of the project can be difficult, resource extensive and time consuming. Most paper-based validation practices require many documents that are managed both electronically (in multiple systems) more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ...investigators as well as other areas. The components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections. It will be important to see what the FDA regulations and the ICH GCP recommendations are in this regard. The key is that the PI and all more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel ...proper garments to minimize the human impact on cleanroom quality. Gowning systems are varied in material, composition, coverage, and control capabilities. The use and donning of the garments can also vary and needs to be controlled in order to establish a consistent manufacturing environment. Areas Covered in the Session: * Identify what garment systems are available. * more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel Overview: This live webinar concentrates on proper cleanroom cleaning, and discusses tools, equipment, agents, personnel training, extent, and frequencies. It is a very practical training session intended to assist personnel involved in the design, cleaning, monitoring, and assessment of cleanroom cleaning procedures. The key benefits of this course are: * In-dept understanding of more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...h risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify test and document. For easy implementation, attendees will receive: * 4 more...

The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel Overview: The purpose of FMEA is to affect the design and the most practical time to do this is when competing designs are being considered, not after choices have been made, contracts signed, and prototypes being built and tested. Of course, there are other reasons for performing a FMEA. FDA requires risk assessment (hazard analysis) but a FMEA conducted late in the product development process more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ...quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: 2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and more...

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel Overview: Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices. According to the FDA, if it isn't written more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel ...the evolution of the standards, describe a Pharmaceutical Quality System and discuss the transition to the Pharmaceutical Quality System. Why you should attend: The US FDA, and regulatory agencies around the world, are actively promoting the concept of a Pharmaceutical Quality System. The concept of a Quality System was imposed on the medical device industry through the implementation of a more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W ...quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms to the appropriate quality standards to meet customer and user needs. You are also aware that there is a paradigm shift from an emphasis on compliance to an emphasis on quality based systems. An understanding of this paradigm shift can be gained by comparing the more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel Overview: Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug more...

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel ...for pharmaceutical manufacturing sites to establish sound quality management system procedures for the disposition of intermediates, API, drug substances, medical devices, finished product, and in-house manufactured components. It will describe a well-defined Quality role, identify requirements for resources, and outline the expectations for documentation review. Additionally, the course more...

Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel Overview: This webinar will cover several recommendations to improve the hospital's Due Diligence when dispensing Schedules II through V controlled substances in a hospital setting and what steps that can be taken to detect and prevent the illicit use or diversion of any controlled substance. Objectives of the Presentation: The following areas are covered: * DEA Office of Diversion more...

Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel Overview: When existing or legacy computer systems are used in FDA or equivalent international environments they should be validated, a process sometimes called retrospective validation. While the industry is very well familiar with the validation of new systems, there are many questions about existing or legacy systems. This web seminar will give a good understanding on the regulatory more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel Overview: HIPAA Business Associate rules have changed in fundamental ways, with new responsibilities and obligations for HIPAA BAs. The session will provide attendees the following tools, benefits, and solutions: * The audience will learn how business associates are now handled under the law and the proposed regulations and what has changed from the old rules. * The suggested and more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel Overview: The new HIPAA Breach Notification Rule required by the HITECH Act within the American Recovery and Reinvestment Act of 2009 went into effect September 23, 2009, requiring all HIPAA covered entities and business associates to follow a number of steps to be in compliance. * The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not more...

Off-Label Promotion of Medical Devices Maximizing Your Performance Claims within FDAs Framework of Acceptable Practices - Webina Overview: The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical, moral, and legal expectations from the FDA. You will improve your understanding of regulatory expectations for your products and improve promotional compliance for released products. The webinar is designed to more...

Bringing Compliance To Design Control For Older Products - Webinar By GlobalCompliancePanel ...e. The webinar is designed to help regulatory Affairs, Quality Engineers, and Design Engineers maintain released products within current regulatory requirements. As an attendee you will learn what the FDAs expectations for your released products are. You will also learn about the paper trail you are required to maintain to show compliance. Compliance regulations are released by regulatory more...

Regulatory Complaint Handling Vigilance Recalls - Webinar By GlobalCompliancePanel Overview: Improper complaint handling can result is serious regulatory problems as well as hitting the bottom line. Recalls, FDA Warning letters & even seizures could result. This presentation will review the regulatory requirements for complaint handling and adverse events reporting in the USA, EU & Canada. Suggestions for investigating and documenting complaints & pitfalls will be included. more...

Overall Residual Risk Evaluation - Webinar By GlobalCompliancePanel Overview: This presentation discusses practical methods of performing Overall Residual Risk Evaluation and methods for documenting the results of the evaluation activity. Overall Residual Risk Evaluation requires a cross-functional team to perform the evaluation, which will be an important part of this presentation. Why you should attend: One of the most important Risk Management activities is more...

Documentation for IEC 60601-1 3rd Edition Compliance - Webinar By GlobalCompliancePanel Overview: In this presentation we will review the certification requirements for documentation of the clauses of IEC 60601-1 Third Edition. The purpose will be to provide medical device manufacturers with information on how to provide certification bodies with the information they need to certify products to the Third Edition in the most efficient manner. By preparing in advance for more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ...ctivities. While Risk Management Plans can be part of the Quality Plans for a product, important characteristics of the Risk Management Plan must be documented to meet requirements. In situations where development and manufacturing activities are located in different areas and are under different management structures, the Risk Management Plan must document the divided responsibilities and more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel Overview: Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official standard. While technically"guidance," FDA has indicated they will enforce compliance rigorously. This complete overhaul of FDA's primary validation standard brings U. S. drug. API, and biologics more...

Validating Rapid Microbiological Methods - Webinar By GlobalCompliancePanel Overview: Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical methods need to be validated prior to their introduction into routine use, and this is especially true for novel technology platforms, such as rapid microbiological methods (RMMs). Because many RMM more...

Excel Spreadsheets Step-By-Step Instructions for Compliance - Webinar By GlobalCompliancePanel Overview: This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session more...

Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel Overview: This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project. Areas Covered in the more...

The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel Overview: This program is intended for those personnel who are concerned with the analysis and correction of problems (deviations and failures). This course provides clarity to the regulatory expectations and guidance, and to the essential skills necessary to ensure effective and efficient investigations. Topics will examine each step of the investigation process from failure identification and more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel Overview: This presentation will go over the steps required for your recruiting process to be successful. The ability to bring in (recruit) on-time study participants whether they be 'normal healthy adults' or patients with the condition being studied is essential for a CRO, a site, a CPU/ CRU for conducting on-time study starts with the full complement of volunteers. For this reason the more...

Understanding the Calibration Curve - Webinar By GlobalCompliancePanel ...ments. As a result, we often make mistakes, generate poor quality data, or perform additional experiments that do not improve the quality of our data. This presentation will help to eliminate these problems. Areas Covered in the Session: * Calibration Basics * Types of Calibration - External standard, Internal standard, etc. * Calibration Options - Response factor methods, more...

Food Drug Cosmetic Act Implementing Regulations Major New Laws - An Overview - Webinar By GlobalCompliancePanel Overview: Food, Drug, and Cosmetic Act history basics will be covered as will implementing FDA regulations relevant to the Food, Dietary Supplement and OTC Drug industries that have followed. Some more recent major new regulations such as the Dietary Supplement Health & Education Act (DSHEA), the Bioterrorism Act, and the Food Safety Modernization Act will also be covered. Areas Covered In more...

Design Control for Medical Devices - Webinar By GlobalCompliancePanel Overview: Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction. This webinar will cover the more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...quality professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program. The purpose of this course is to provide an more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel ...s for incorporating it into your companya ™s ongoing quality system. Why you should attend: If you don't know what the FDA inspector is going to look at when (s)he performs his/ her audit, how can you really know what to prepare for? Even a thorough internal audit may not focus on the areas that the FDA inspector will. The most effective way to increase the likelihood of your internal more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ...rers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have a procedure in place that describes the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered "approved." You must also have a system in place to routinely assess your suppliers, and set forth the more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel ...NDA/ BLA/ ANDA holder can demonstrate to the FDA that the quality systems at the site are in compliance with the GMPs and that appropriate facilities are available to support manufacture of the product. It is therefore important to present the organization in the best light possible. Areas Covered In the Seminar: * Pre-Approval Inspections * Overview of the pre-approval more...

Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel Overview: This interactive webinar will review the regulatory requirements for an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. Common pitfalls and means of overcoming them at each of the steps will be more...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel ...t of both GMP and GLP laboratories. It contributes to the quality and therefore reliability of the generated data which is required for critical for go-no-go decisions. An effective Equipment Program is also an expectation in GLP and GMP laboratories. Areas Covered In the Seminar: * FDA requirement for Equipment systems * Overview of GMP/ GLP requirements for equipment * more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl Overview: Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U. S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. FDA issued a 28-page Proposed more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel Overview: Medical devices are classified into three classes, Class I, II, and III, based on the level of control necessary to assure the safety and effectiveness of the device. Recalls of Class II devices represent 61% of all device recalls over a review period, followed by Class III devices at 28%. This Webinar will provide a recent update on the latest trends and causes for device recalls and more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel Overview: Promoting a drug or device for a use not approved by the Food and Drug Administration is illegal. As a result of this practice, called "off-label promotion," life sciences companies have been fined unprecedented amounts of money and their executives have been prosecuted criminally. In addition to the regulatory and criminal consequences of off-label promotion, companies that promote more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel Overview: This web seminar has been designed to provide you with a clear understanding of project management skills to apply to running clinical trials. It will ensure you gain a clear understanding of the tools and techniques of project management for clinical trial and how they can be applied to your own pharmaceutical projects in the work place. In addition to key project management tools more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel Overview: Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel Overview: There is an on-going major shift in the emphasis of U. S. FDA cGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. The Agency has come under increasing negative publicity due to multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and more...

Introduction to Investment Risk - Credit Market and Portfolio - Webinar by GlobalCompliancePanel Overview: This three hour overview of investment risk will provide the fundamentals to market, portfolio, and credit risk management that all investors, and those in financial services need to comprehend. Regardless of job titles, investment risk management is a shared responsibility by a wide range of managers. Compared to accounting, risk is an immature discipline with a variety of risk more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...ecognize when you are using software in production or the quality system * The use of Excel tools to help ensure spreadsheets are built correctly * The FDAa ™s requirements and expectation for production and quality system software * The reason for Part 11 and some of the implications * The requirements of Part 11 for electronic records and the current guidance document more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel Overview: This webinar concentrates on the value of creating a master plan for contamination risks within a GMP manufacturing company. It provides an introduction to the creation, implementation, and maintenance of a Contamination Control Master Plan. Key benefits of this seminar include: * Achieve satisfactory inspections more easily * Higher assurance of new medical product more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel Overview: This webinar concentrates on identifying and discussing testing and certification requirements associated with cleanrooms. The key benefits of this course are: * In-dept understanding of industry standards, processes, and criteria for testing cleanrooms and HEPA filters * Achieve satisfactory inspections more easily * Higher assurance of new medical product approvals more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel ...ess and shows that the process can consistently produce a quality product. Writing and executing good process validation can be a daunting task given the complexities of today's biotech and pharmaceutical processes. Guidance's are helpful in writing process validation protocols and deciding what can be, or should be, varied in the process. The notions of critical process control parameters and more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel Overview: Although Part 11 has been around for over a decade, lack of visibility can sometimes render compliance with this regulation an afterthought. Due to serious inefficiencies and non-conformance issues associated with trying to address Part 11 late in the system lifecycle, it is important to give the technical requirements due consideration early in the process. A good understanding of more...

International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel Overview: Where business is concerned the world is becoming a smaller place. Trade boundaries are disappearing, and many companies have subsidiaries around the world. Multi-national corporations needed a simpler way to put together their consolidated financial statements. Already Australia, most of Europe, and many other countries have adopted International Financial Reporting Standards. more...

Practical Laboratory Statistics - Webinar by GlobalCompliancePanel Overview: This presentation will attempt to remove the fear of statistics that most people share. We will not spend much time on complex equations. Rather, we will focus on the concepts of statistics, and how you can use these concepts to interpret your laboratory results. Our focus will be on using basic spreadsheet functions to compare data sets generated from many different kinds of test more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global ...y steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Why Should You Attend: We have found out, through auditing many organizations world-wide that the organizations are pretty good more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ...of warning letters is increasing proportionally and we as quality and other professionals utilizing the technology and systems to support our businesses are not ready - we are not ready to prepare and host FDA inspections when Part 11 is in scope, we are unsure how to best use and implement Audit Trails and certainly we have challenges with internal and external auditing for Part 11 compliance. more...

Reprocessing REUSABLE Medical Devices-Cleaning Labeling Requirements - Webinar By GlobalCompliancePanel Overview: Much attention has been paid to the regulatory requirements of reprocessing SINGLE use devices. However, there is increasing attention being directed towards reprocessing REUSABLE medical devices and regulatory requirements. The purpose of this seminar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing & validating reusable medical more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa ... This webinar will provide a methodology for developing quality requirements for PDMA systems and will examine the benefits of leveraging those requirements to plan and drive the validation effort. Why should you attend: With the FDA announcing that it will be performing Part 11 audit this year and the FDA currently inspecting and issuing warning letters to companies that have violated more...

Food Safety Management Systems - ISO 220002005 - Webinar By GlobalCompliancePanel Overview: This presentation will assist organizations within the food chain to understand the requirements to meet the international standard for Food Safety Management. Areas Covered in the Session: The following areas will be addressed: * Key terms and definitions * General Requirements * Documentation * Management Responsibility * Resource Management * more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel Overview: The public media has been reporting the abuse of narcotic drugs prescribed for pain management with its focus on the legitimacy of prescriptions and the dispensing by a pharmacist. Both federal and state regulations have placed the responsibilities on the physician who wrote the prescription and the pharmacist who filled the prescription. Today's pharmacists will need to familiarize more...

Hazard Analysis vs FMECA Differences and Commonalities - Webinar By GlobalCompliancePanel Overview: The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design. The presentation will explain both methodologies and will show ways how these tools can be used to complement more...

Labeling Requirements for Dietary Supplements - Webinar By GlobalCompliancePanel Overview: This webinar points out current labeling issues including misbranding that are eating into profitability of dietary companies. The webinar teaches the attendee how to avoid common labeling compliance issues including: * Misbranding * Misleading claims * Misleading statements * Directions of use The webinar focuses on general labeling provisions for dietary more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) One major change to an existing product having an existing 510(k), for the need for a new 510(k). Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...similar. How can these be verified and validated? Company quality data must be more "science based". What V&V (verification and validation) planning steps are expected under the CGMPs and other guidance documents for such apps software? How can these consistently be executed? Where does ISO 14971, ICH Q9, and similar risk management systems come in? This webinar will evaluate the climate that more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel Overview: This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. One very simple approach more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel Overview: This presentation will answer some of the frequent questions of new trainers or training managers. These include: worker training requirements, the frequency of training, how do design an effective training program, who is responsible for training, training effectives and training documentation. By examining the GMP expectations on training from different regulatory bodies (from the more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel Overview: Most sophisticated businesses use social media sites such as Facebook, MySpace, Twitter, and LinkedIn to promote their services, connect with their customers, and as a overall component of their business strategy. Physicians and other healthcare providers have begun to experiment in the social media environment, but most are concerned that the special rules applicable to the more...

Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel Overview: Preparation and organization are the keys to a successful audit. This session will allow your team to anticipate the auditors needs and result in the facility's ability to achieve the maximum benefit and score from the audit. Why you should attend: More and more customers are requiring GFSI audits such as ISO 22000, BRC and SQF or accepting them in lieu of their own audits. more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel Overview: A comprehensive review of an ideal chemical control program will be presented. The guidelines presented will enable your company to implement programs that are cost effective and meet or exceed the expectations of major QSR, and GFSI audit criteria. This presentation will provide not only a provide schematic for management and control of chemicals, but an interactive and customizable more...

Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel ...Preventive Action findings in medical device manufacturer quality systems to determine FDA's concerns. The FDA and ISO 13485 requirements for CAPA will be reviewed to identify how procedures may define a compliant CAPA system. Implementation and maintenance of the CAPA system will be explored. FDA indicates that CAPA systems should be risk-based. The presentation will give an example of how more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ...tive actions is clearly stated in ICH Q10, Pharmaceutical Quality System, and supported in the FDA Guidance to the Industry, Quality System Approach to Pharmaceutical CGMP Regulations. This course will include a discussion of the Deviation System, what should be investigated and the level of investigation. Several tools that will lead to the identification of the root cause will be discussed. more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel Overview: In this NDA Approval Process training Webinar learn the guidance and regulations governing FDAa ™s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom Overview: If you handle any electronic patient information, don't miss this teleconference on compliance with the HIPAA security regulation. Electronic patient information is everywhere; not only is electronic protected health information in the obvious places such as practice management systems and electronic medical records, but also in less obvious places such as copiers, printers, scanners, more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel Overview: It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? There are many reasons, which will be discussed, but regardless of the causes, more...

Electronic Raw Data in Regulated Environments - Definition Recording and Archiving - Webinar By GlobalCompliancePanel Overview: All regulations have strict requirements for electronic raw data and other e-records. The objective is to ensure accuracy, integrity, authenticity, security and availability of records during the entire life from generation to deletion. While the intent is the same for all regulations only FDA's 21 CFR Part 11 and the EU equivalent Annex 11 have well defined requirements but still more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel ...sues. There is a great deal of concern at FDA over the quality of the information being reported and the timeliness. Some at FDA are concerned that manufacturers have not placed adequate attention to following these regulations, which they consider to be primary indicators of safety issues and therefore very important to the public health. FDA is working to improve reporting by more...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel ...lf audits. Internal audits are a core component of the Quality Assurance and Food Safety program. Ensuring the team representatives are trained and calibrated is a critical aspect of the program. An untrained team will miss important audit items, compromising the confidence in the companya ™s ability to assess and improve its own systems. Why you should attend: Maintenance is often more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ...more or less management skill levels than any production, quality or purchasing operation - risk management simply requires attention. This session will establish a way of thinking about risks and their management that allows managers to simply define and incorporate risk reduction strategies into their own processes. Emphasis is on defining and managing risk levels prior to problems that may more...

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel ...itutional Review Boards (IRBs). Why you should attend: Quality assurance is defined as a "systematic and independent examination of trial-related activities and documents" that allows an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance that govern clinical research. This course will provide an overview of auditing skills and more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel ... qualified for use in regulated testing. This includes quality control labs attached to cGMP facilities, GLP labs supporting animal toxicology studies and GCP labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated. This seminar will review the regulations that cover each environment and present simple and effective strategies for satisfying the more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ... product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the processes associated with each principal to design, implement, and maintain a combination system that surpasses compliance requirements. The seminar will focus primarily on the principles embodied in CFR Parts more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ... CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820. 30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions. Objectives: * Know the differences more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel Overview: New regulations modifying the HIPAA Privacy and Security Regulations have been proposed and/ or finalized to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009. New requirements for business associates of HIPAA covered entities and requirements to notify individuals in the event of a breach are only two of the many areas more...

Excel Spreadsheets - Develop and Validate to Eliminate 483s - Webinar By GlobalCompliancePanel Overview: Learn how to Use excel spreadsheet for GXP data and reduce validation cost and time. Configure Excel for audit trails, security features, and data entry verification. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel Overview: Within the next few weeks and months the FDA will conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure accuracy, integrity, authenticity and availability of electronic records, and the FDA plans additional 'for cause inspections'. Inspections are planned for US but also in foreign countries. The more...

Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel Overview: Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization approach, as well as the frequency of the sanitization process have everything to do with its success. This presentation focuses on the factors that can lead to water system sanitization success as well as failure so that more...

Preventive and Corrective Maintenance Protect your assets Protect your consumers - Webinar By GlobalCompliancePanel Overview: A how to guide to meeting customer expectations of the maintenance function. An overview of industry best practices and a review of some leading software solutions. Why you should attend: Maintenance is often found to present the greatest area of opportunity for improvement in the food safety chain. Lack of control of parts and condition of equipment often contributes foreign more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel Overview: The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not issue more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane Overview: This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result more...

Statistical Sampling Plans for Audits - Webinar By GlobalCompliancePanel Overview: The purpose of auditing is to identify failures in the system or gross negligence. The real question, "how bad does the system need to be for auditing to work?" This talk will look at statistical distribution for rare events to show that the sample size needs to larger when the systems are better. This is a paradox for most auditors who when a problem is discovered increase their more...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar By GlobalCompliancePanel Overview: In order to proactively address areas of concern to the FDA and other regulators, All units within each pharmaceutical firm should review recent regulatory observations and proactively establish programs or systems to address the regulatory concerns. In this webinar we will focus on the laboratory and recent FDA laboratory based operations. We will review observations, identify the more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...sider in their annual Management Review of their existing quality management system. Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do internally. A review of recent information from the Agency, other goals of the Agency that have more...

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach QSA to the Pharmaceutical GMPs - Webinar By Global ...Quality System Approach to Pharmaceutical Good Manufacturing Practices which provided a quality orientation to the GMP's Then in June of 2008, The International Conference on Harmonization (ICH) published ICH-Q10, Pharmaceutical Quality System. These guidance documents have provoked thought and raised questions about existing pharmaceutical. During this webinar, the present status of more...

The FDAs Working Group Reports I II - New Directions - Webinar by GlobalCompliancePanel Overview: This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do internally. Examination of two recently published reports by the FDA's CDRH (devices) have identified major areas of concerns: 1) 510(k) Working Group's Preliminary Report and Recommendations, and 2) more...

The Process Approach to Auditing - Webinar By GlobalCompliancepanel ... 2000 provides a focus on the processes that comprise the quality management system (QMS). Also, the general requirements laid out in Clause 4. 1, the foundation for auditing a process-based system, are taken up for discussion at this webinar. There are eight basic processes that an organization must have to function effectively. These are: * Management of the Quality System * more...

The Advantages of Linking Management Systems - Webinar by GlobalCompliancePanel ...It's important to improve the dialogue between financial, quality, IT and environmental management systems. Members of these management systems need to understand what the others do. Quality and environmental managers need to understand the language of finance and the effect of operations on the bottom line, while financial managers need to know how quality, environmental and IT managers can more...

Audit Committee Responsibilities for Internal Controls - Webinar By GlobalCompliancePanel Overview: With the advent of the Sarbanes-Oxley Act, audit committees are under increased scrutiny for helping management set the tone at the top and ensuring internal controls are documented and tested. As a matter of fact, the Audit Committee has the PRIMARY responsibility for oversight of internal controls. One thing audit committee member should expect is to have a clear understanding of more...

ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel ...lp you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: more...

Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel Overview: This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details more...

Basics of OTC Drug Labeling Compliance - Webinar By GlobalCompliancePanel Overview: The webinar will help participants review and understand FDA requirements for OTC Drug labeling and compliance. OTC Monographs and their importance to OTC Drug marketing in the U. S. will also be covered. Why should you attend: Anyone who wants to market OTC drugs in the U. S.A. and assure that they're labeled properly with appropriate claims will benefit from this program/ webinar. more...

Introduction to Operational Risk - Webinar By GlobalCompliancePanel ... have witnessed in such diverse organizations as Toyota's quality failures, banking's loan processing failures, organizations need to address operational risk in a holistic and systematic process. This course will provide an overview of the Basel framework to operational risk and argue that is a viable means for non-banking organizations to categorize and classify the major areas of operational more...

Know Your Customer - The DEA Due Diligence - Webinar By GlobalComplaincePanel This training will cover several recommendations to improve Due Diligence when distributing Schedules II through V controlled substances and regulated chemicals to your customers and what steps can be taken to prevent the illicit use or diversion of any product sold to a customer. As a firm handling these products, you will get a better understanding of what is required from a DEA registered more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans - Webinar by GlobalCompliancePanel This course provides the attendees with the tools needed to understand and implement acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plana ™s performance using the operating characteristic (OC) curve. Participants will gain a solid understanding of how the OC curve is built, how to use it, and how to more...

Good Documentation Practices in a Regulated Environment - Webinar by GlobalCompliancePanel Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success, and avoid those frustrating, embarrassing discussions of missing or doubtful data, employees recognize and must follow Good Documentation Practices (GDP). These practices apply to all pharmaceutical more...

The Drug Development Path - From RD to Commercialization - Webinar By GlobalCompliancePanel An overview of the drug development process, reviewing key deliverables for each stage of the development path with a special focus on managing the development process when using external resources such as Contract Manufactures, Contract Testing Labs and Contract Research Organizations. In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work more...

HIPAA Compliance and Workforce Training for Medical Practices - Webinar by GlobalCompliancePanel Training is required in a number of areas of the HIPAA regulations and their policy implementations at medical offices. The HIPAA Privacy Rule includes basic protections of uses and disclosures of protected health information that every staff member must be aware of, from avoiding discussion of patient-related information outside of the office, to taking precautions when faxing information to more...

Process Verification and Validation - by GlobalCompliancePanel This webinar will provide valuable guidance to regulated companies in development, implementation, or refinement of their manufacturing process verification and validation programs. It will evaluate validation practices that are more in agreement with ICH Q7 and Q8 than previously accepted validation methods, and will provide thought-provoking questions for FDA-regulated companies. Enhanced use more...

Full Day Virtual Seminar - Designing and Implementing the Quality System for Combination Products - by GlobalCompliancePanel ... product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the processes associated with each principal to design, implement, and maintain a combination system that surpasses compliance requirements. The seminar will focus primarily on the principles embodied in CFR Parts more...

Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar by GlobalCompliancePanel Excel Applications are widely used in laboratories, offices and manufacturing e. g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel has not been designed for more...

Complaint Handling in Compliance with FDA and ISO Regulations - Webinar by GlobalCompliancePanel This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also more...

Root Cause Analysis Shutting Down the Alligator Farm - Webinar by GlobalCompliancePanel RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur. This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters. Emphasis will be placed on realizing system interactions and cultural more...

Full Day Virtual Seminar - Reduce Software Validation Costs and Pass the New 21 CFR Part 11 Inspections - Webinar by GlobalCompl ...ystem used in laboratory, clinical, manufacturing and the quality process has to be validated. Participants will learn the latest techniques for complying with 21 CFR Part 11 that greatly reduce software validation project time. Methods for decreasing resource requirements, and making documentation more manageable and understandable often result in a savings of two-thirds the costs. more...

Computer System Validation Step-by-Step - Webinar by GlobalCompliancePanel Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan, documentation of ongoing performance, structure of validation report. more...

Using Statistics to Determine Sample Size - Webinar by GlobalCompliancePanel This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain more...

Training Requirements and Practices to Assure QSR and ISO Compliance - Webinar by GlobalCompliancePanel ...satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them. A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and more...

Interfacing Design Verification Process Validation and Design Validation - Webinar by GlobalCompliancePanel There is confusion between the requirements for Design Verification, Process Validation and Design Validation. While each of these processes has its own requirements, they do not stand alone, they are linked together. As this linkage is not well understood, it is the source of FDA observations and potential release of products that do not meet requirements. more...

How to Prevent Food Safety Problems Using Your Current Quality System - Webinar by GlobalCompliancePanel ...in terms of applying the principals and tools involved in quality control and improvement. Unfortunately, food supply chain members have lived outside of the quality world and have not invested the time, training or money to learn and apply the disciplines needed to bring quality into preventive levels of control. Visual inspection in many industries has long ago been rejected as a means of more...

Crisis Management and Risk Communication - Webinar by GlobalCompliancePanel As your company's system continues to grow, the potential for "crisis issues" to occur grows proportionally. The concern for food safety to your customers and employees must be a constant area of focus for all operators in the system. Ultimately, how well your company manages the crisis situations it will make a significant difference in how your company brand is perceived in the public's eyes more...

How to Write Standard Operating Procedures SOPs and Work Instructions WIs - Webinar by GlobalCompliancePanel This webinar is designed to outline the characteristic of an effective work instruction, and Standard operating procedure. The webinar is also designed to help differentiate Work Instructions from Standard operating procedures. Attendees will learn the steps used to write effective work instructions and Standard operating procedures. more...

Project Management for the Phase 3 LCM Life Cycle Management of the Drug Development Process - Webinar by GlobalCompliancePanel This web seminar has been designed to provide you with a clear understanding of project management skills to apply to running phase 3 clinical trials. more...

21 CFR Part 11 - Compliance for Electronic Records and Signatures - Webinar by GlobalCompliancePanel This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to more...

Microbiological Foodborne Threat - Risk Mitigation and Crisis Management - Webinar by GlobalCompliancePanel As your company's system continues to grow, the potential for "crisis issues" to occur grows proportionally. The concern for food safety to your customers and employees must be a constant area of focus for all operators in the system. Ultimately, how well your company manages the crisis situations it will make a significant difference in how your company brand is perceived in the public's eyes more...

Understanding Analytical Test Results Comparing Two Sets of Data - Webinar by GlobalCompliancePanel The class will cover the understanding the properties of single test results and how they may be compared. There are many problems that arise from a misunderstanding of the properties of single data sets and the problems are compounded when data sets are compared. The discussion will cover the misconceptions and present methods to allow proper comparisons, while considering the risks inherent more...

GMP Expectations for Products Used in Early Phase IND Studies - Webinar by GlobalCompliancePanel FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1. Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the more...

Transfer of Analytical Methods FDA Expectations and Tools for Implementation - Webinar by GlobalCompliancePanel Laboratories that work in a GMP environment are required to have documentation to show they are qualified to run specific, consistent and reliable analytical test methods. Method qualification of a method can be achieved in three ways: Validation, Verification (Compendial Methods) and Method Transfer (company methods). Lack of such documentation can result in warning letters from both the FDA more...

Auditing API Manufacturers and Suppliers - Webinar by GlobalCompliancePanel This program will focus on the basics needed to perform an API audit. Performing an audit is not simply an act of visiting a firm and checking off a list of questions. Auditing API producers and suppliers is an important part of GMP compliance programs. Identifying what approach or process to use is examined and the tools to utilize during an audit is also discussed. Audits at best are more...

21 CFR Part 11 - What you need to know to pass the new FDA audits - Webinar by GlobalCompliancePanel This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel FDA recently released a final rule regarding the parameters in which a device manufacturer can modify label changes to a product. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence more...

ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel Active Pharmaceutical Ingredient Good Manufacturing Practices (API GMP) are established and defined by the ICH Q7 Guidance. The international supply chain associated with API manufacturing was one of the greatest drivers for the development and international adoption of these expectations by regulators world-wide. The growth in the number of FDA inspections of API producers outside of the USA more...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel ...y of software used in manufacturing, devices, design, and quality systems. FDA has cited numerous companies on software verification and validation issues in Warning Letters and inspectional observations. The presentation will address some common sense approach to this dilemma without going overboard; such as having V&V plans and processes that clearly define the completion criteria for a more...

Medical Device Classification - Webinar by GlobalCompliancePanel In 1976, the FDA received authority to regulate medical devices. The plan, written into law, establishes three risk classes for devices (I, II, and III). The three risk levels require different types of control. The webinar explains the two dimensional sy The EUa ™s MDD classifies devices using a rule based system found in Annex IX of the MDD. Devices fall into four risk categories (I, more...

BRC Risk Analysis - Webinar by GlobalCompliancePanel Risk Assessment is a fundamental and intuitive activity that is not new to manufacturing professionals. Bringing consciousness and tangibility to this process is the challenge often faced. A practical guide documenting the process will be the topic of this training. This presentation will take you step by step through the creation of each type of risk assessment required by the BRC. Process and more...

Supplier Evaluation and Assessment How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner - Webinar by Global Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier more...

The ICF Process Tips on Achieving Optimal compliance and Comprehension - Webinar by GlobalCompliancePanel The ICF process, which involves communication between a consentee (patient/ subject) and a consenter (staff clinician/ designee), is a vital component to the authorization of any medical intervention or clinical research trial. IRBs, sponsors and clinical sites all share the responsibility of ensuring an adequate ICF process. Any inadequate ICF training to clinical sites and /or unclear more...

Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel The FDA has proposed an overhaul of the 510(k) clearance system In its release of reports from two working groups, the FDA's goals are to increase the predictability and transparency of the 510(k) process and enhance FDA scientific decision-making. It will also increase the burdens on industry. For example, if finalized, there will be a new subclass of Class 2 products for which clinical more...

European Drug Safety and Pharmacovigilance Compliance - Webinar by GlobalCompliancePanel This webinar will describe European PV requirements, including compliance with applicable laws, regulations and guidance. In addition, attendees will learn how to compare the company's PV operations to applicable best practices in Europe. more...

Master Verification and Validation Planning to Meet US FDA ISO 13485 and 149712009 Requirements - Webinar by GlobalCompliancePan FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to more...

Regulatory Complaint Handling MDRs Recalls - Webinar by GlobalCompliancePanel Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms. Many medical device firms face regulatory issues as a result of inadequate complaint handling. FDA has explicit complaint handling requirements and poor complaint & reporting procedures often more...

Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products - Webinar by G What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product Determine which Center will review my combination or non-combination product? These topics and more will be addressed during this Webinar, more...

The HITECH Acts Impact on HIPPA - Webinar by GlobalCompliancePanel The new requirements of the HITECH Act have a significant impact on the privacy and security of health information. This webinar will cover the changes required by the HITECH Act and the actions that needed to taken regarding breach notification, business associate contracts, training of staff and security of PHI for business associates. We will also discuss the best practices for data more...

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