Key Web-based Seminars

Accelerated PMP E Learning ...ssary knowledge needed to manage projects effectively. Key Features: Live Online sessions, 7 lectures of 3 hrs each only on weekends, to continue for 4 weeks. Opportunity to discuss directly with the faculty & clarify all your doubts. Question bank of 1500 questions covering all the knowledge areas & processes. Audio recordings of faculty available for repeated  more...

Webinars Online, educational sessions, describing and demonstrating key techniques and approaches to the analysis of business process and systems. Topics covered will include (in different sessions): Business Process Modelling Notation (landscapes and workflows), Unified Modelling Language (primarily use case, activity and class mdoelling), Data Modelling (entity relationship and physical schema  more...

Call Center Social Media Certification - Live Online - May 9-11 2012 Social media represents one of the most significant changes in consumer media behavior in history, resulting in fundamental shifts in the way companies communicate and interact with consumers. This course provides the practical knowledge and insights required to establish objectives and strategies and to properly select the social media platforms to engage consumers, while monitoring and measuring  more...

LEGAL LANDMINES EXEMPT VS NON-EXEMPT CLASSIFICATION ISSUES Dona ™t get caught by the Department of Labor for misclassification of your employees! Attend this informative and engaging on-line live webinar today to learn key methods to avoid FLSA liability for misclassification of employees. This webinar will be presented by an experienced employment attorney who will provide an in-depth summary of what you need to know and answer all your FLSA and  more...

Employee Handbooks Dos and Donts ...our employee handbook should contain a What are the five key disclaimers and qualifiers every handbook must contain Date: December 7, 2010 Time: 1: 00-2: 00p. m. EST Cost: $199 per attendee per computer terminal Registration: Purchase on-line now at http://www. hrlearningcenter. com/ employeehandbooksdosanddonts-2.  more...

Spring Web Flow ...ystem. Then we dive into Web Flow itself, and develop key concepts of flow, state, transition, and action. We get moderately complex applications up and running with these elements, and see how the JavaBeans used to power a flow can also take advantage of Spring configuration and dependency injection. Then we move into more advanced techniques including custom converters, validators, and  more...

MOC 8820 - Payroll - US in Microsoft Dynamics GP 10.0 This Microsoft Dynamics GP Payroll training class provides an in-depth view of the extensive functionality contained within the Payroll application. Besides learning the functionality, this class also explains tips and techniques that can help make an implementation successful, and gain a more thorough understanding of the Payroll application and its capabilities.The Dynamics course covers the  more...

Java Web Services Training ...web services on the Java EE platform. Students learn the key standards -- SOAP, WSDL, and the WS-I Basic Profile -- and the Java architecture that has evolved to build interoperable services and clients. JAX-WS is central to the course, and we cover both WSDL-driven and Java-driven development paths, as well as message handlers and attachment support. With the new Provider and Dispatch APIs,  more...

Intermediate Java Training ...ign and development. The latter part of the course moves key parts of the Java SE Core API, including collections, exception-handling, logging, streams, and object serialization. The course software also includes an optional overlay of workspace and project files to support use of the Eclipse IDE in the classroom. (This requires that the instructor be experienced in use of Eclipse and able  more...

MOC 6234 - Implementing and Maintaining Microsoft SQL Server 2008 Analysis Services This SSAS training class teaches students how to implement an Analysis Services solution in an organization. The class discusses how to use the Analysis Services development tools to create an Analysis Services database and an OLAP cube, and how to use the Analysis Services management and administrative tools to manage an Analysis Services solution.This SSAS class targets people who design and  more...

MOC 5928 - Managing Projects This Microsoft Project training class provides students with the knowledge and skills to initiate, plan, execute, monitor and control, and close enterprise projects by using the Microsoft Office Project Server 2007 enterprise tool.This is the second class in the Microsoft Office Project 2007 Official Curriculum series and covers the Microsoft Enterprise Project Management (EPM) Solution.This  more...

MOC 5927 - Microsoft Office Project 2007, Managing Projects This Microsoft Project training class provides students with the knowledge and skills to build, maintain, and control well-formed project plans.This is the first class in the Microsoft Office Project 2007 Official Curriculum series and serves as the entry point for other Microsoft Official Curriculum (MOC) courses covering Microsoft Office Project 2007 and the Microsoft Enterprise Project  more...

How to Achieve Maintain ERP Systems Master File Data Integrity You are invited to attend the Manufacturing Executive Institutea ™s May 19th 2011 3rd Thursday - a Operations Improvement Series FREE webinar, How to Achieve & Maintain ERP Systems Master File Data Integrity. Contrary to the popular belief that modern, fully-integrated information systems provide executives with the tools to make more effective and efficient decisions, there is increasing  more...

Early Intervention Field Trauma Training ... Identify emergency management, phases of disaster, and key concepts of disaster mental health a Discuss responder resiliency, prevention and self-care strategies COURSE EVALUATION: Students are required to attend all sessions or complete make-up assignments in order to successfully complete this program. Please refer to the Student Evaluation Package for the grading, the assignment  more...

Keeping Work Order and Purchase Order Due Dates Accurate - A Key to Production Planning Success Does your company, at this very moment, have past due work orders or purchase orders? Does your company utilize a priority planning system (MRP, KanBan, etc.) to manage the flow of materials through the factory? Does your company have a materials management organization that responds to expedite activity more than to planned activity? This FREE 1-hour webinar will present some new thoughts and  more...

Key Factors to Write an Effective Standard Operating Procedure SOP Work Instructions WIs - Webinar By GlobalCompliancePanel This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. Tuesday, February 7, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Reusable Device Cleaning Disinfection and Sterilization Validations Overview and Key Design Considerations for Device Engineers Validation of reusable medical devices requires that the manufacturer develop methods for cleaning (after use) washing to remove all foreign matter possibly disinfecting and repackaging for the next use. The diversity of medical devices their intended use and classification in accordance with the food and drug administration requires that the manufacturer develop and validate the reprocessing  more...

Key Steps for Risk Assessment - Webinar By GlobalCompliancePanel The webinar focuses on effective implementation of QRM through the understanding of the ICH Q9 process and principles of QRM. By reviewing the standard terminology of risk management and laying the foundation for a more practical approach to applying the QRM principles of ICH Q9 to any biopharmaceutical manufacturing process and equipment, it enables you to speak the same "language of risk" as  more...

Best Practices in Key Financial Metrics - Webinar By mentorhealth Hospital executives have a hard job to do! In attempting to create and achieve an effective strategic plan, there is a great need to determine specific outcomes that will be consistent with the organization's underlying mission, broad policies, culture and accepted industry normsa .But what exactly does this mean? What are the elements that will be instantly recognizable as "a" or "the" key  more...

New Amendments of Critical Parameters in Canadian Clinical Trials - Webinar By GlobalCompliancePanel This presentation will help you to understand the last changes that occurred in Canadian ethics regulations. The presentation will clarify for sites and sponsors how to easy the ethics process and how to get more quicker the ethics approval. Also after the presentation the participant will understand how to apply the last changes in ethics regulation in the day-to-day work. Every member of the  more...

Key Aspects of the Trial Master File and How to Pass FDA Inspection - Webinar By GlobalCompliancePanel This presentation will help with preparing the site and the study team with how to successfully prepare for an audit, how to identify risk of noncompliance, what to do before, during and after an audit. All these are done with the primary goal in mind: getting no audit findings. Thursday, November 3, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Design History File DHF the Device Master Record DMR and the Device History Record DHR Principles on Lean Documents and Lean Co 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. Tuesday, December 13, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Clean Room Microbial Load and Characterization of Microorganisms in the Clean Room Environment - Webinar By GlobalCompliancePane A summary of test methods will be covered, and a review of types of microorganisms that can be present, will be discussed. A general review of environmental niches where they may be present will be discussed. You will be introduced to the different methods available to conduct testing. Key areas discussed will be Compressed Air, Personnel Monitoring, Surface and Raw Material Monitoring.  more...

Working with the Pharmacopeias and Compendia - Webinar By GlobalCompliancePanel ...trol 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 for existing products, they may also be employed in developing  more...

Performance Management The Key to the Castle - Webinar By TrainHR This webinar has been carefully designed to ensure an optimum learning experience. We have drawn upon the expertise of many of the best minds in the industry in creating a program that will not only inform, but teach practical skills, as well.  more...

Strategies for Retaining Key Employees - Webinar By TrainHR This webinar will cover key strategies and behaviors that will encourage your best employees to stay through good times and bad and contribute to the success of your organization.  more...

Software Verification and Validation Planning to Meet FDA Requirements - Webinar By GlobalCompliancePanel The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. Wednesday, October 19, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Designing an Effective Cleaning Validation in todays Regulatory Environment - Webinar By GlobalCompliancePanel This webinar concentrates on designing effective cleaning validation studies. Key benefits of this seminar include: Learn what steps should be followed. Identify critical parts of cleaning validation process. Achieve satisfactory inspections. Higher assurance of new medical product approvals. Minimize nonconformances. Reduce rates of batch rework and rejections. Avoid product recalls.  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP The verification and validation of electronic records and electronic signature software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of FDA Guidance's, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to  more...

HR Metrics for the Human Resource Executive by TrainHR In this webinar we will discuss measurements and ratios that will be meaningful to the Human Resources Department and the Executive Team in determining successful use of human capital. Human Resources uses both left and right brain thinking to achieve its objectives and key metrics for both will be covered. We will also give you practical ongoing measurement tools that should apply to all types  more...

How to Create Configure and Manage a Design Inputs - Design Outputs Traceability Matrix utilizing the principles of Lean Documen ...se errors, while presenting a fresh new approach to these key and related documents. Why you should attend: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices - which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and  more...

Creation and management of a Controlled Document System for a Life Sciences manufacturing plant utilizing the principles of Lean ...nd the corresponding Theory of Lean Configuration to this key part of a QMS. Why you should attend: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in controlled documents - which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and manufacturing resources are spending way too much  more...

Creation of DHFs DMRs and DHRs utilizing the principles of Lean Documents and Lean Configuration by GlobalCompliancePanel ...aster 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 formulates a corresponding Theory  more...

Creation of DHFs DMRs and DHRs utilizing the principles of Lean Documents and Lean Configuration - by GlobalCompliancePanel ...aster 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 formulates a corresponding Theory  more...

Human Behavior in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ... contaminants and how they are affected by humans. The key benefits of this course are: In-dept understanding of cleanroom contaminants. Achieve satisfactory inspections more easily. Higher assurance of new medical product approvals. Minimize nonconformances. Reduce rates of batch rework and rejections. Reduce personnel-related environmental contamination  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...

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...

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...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ...lizing human subjects. See why AEa ™s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/ his charge. Learn how well-controlled and well-conducted clinical trials that follow the Code of Federal Regulations and the Principles of GCP are important to both sponsors and CROa ™s / investigator sites. See how compliance with the  more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel ...ll 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 need to know and examine during an audit of your CMO or API suppliers. The webinar leader will help you identify key regulatory and  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel Overview: The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ... RCA is a major element of cGMP compliance, and is also a key source of regulatory problems. How can companies allocate scarce resources to 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  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ...", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must be considered. Why Should You Attend: Verification and validation requirements have always been part of the US FDA's GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems  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...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...ed to Z1. 4 plans + The RQL point is the key + Making the curves cross at one point + How to employ switching rules o The OC curve + It is not the ideal curve + The difference in shape and the problems it causes o Consequences of moving from Z1. 4 to c=0 + Inventory  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ...s and the ICH GCP recommendations are in this regard. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. To do this is ethical research. To not follow the protocol and document study conduct carelessly is folly. Why should you attend: All CRO's, Sites, and Sponsors of Clinical Research involved in the drug and device  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel ...ement of their supply, and control of human variables. Key benefits of this seminar include: * In-dept understanding of cleanroom garments and their use. * Reduce personnel-related environmental contamination issues. * Achieve satisfactory inspections more easily. * Minimize nonconformances. * Reduce rates of batch rework and rejections. * Avoid product  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ...ing, and assessment of cleanroom cleaning procedures. The key benefits of this course are: * In-dept understanding of cleanroom cleaning methods. * Achieve satisfactory inspections more easily. * Higher assurance of new medical product approvals. * Minimize nonconformances. * Reduce rates of batch rework and rejections. * Reduce cleaning-related environmental  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...se. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high 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  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel ...pharmaceutical projects in the work place. In addition to key project management tools and techniques a checklist of over 100 clinical trial activities for a clinical trial will be supplied as part of the seminar, which will include the following: * Obtain a brief from the Project Sponsor which defines the clinical trial objectives, rationale, outline timeframe, and estimated budget  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...pliance as well. Thus, the U. S. FDA has indicated that a key area gaining attention is a company's suppliers, for services and products / components. Why needed? FDA expectations? How are successful companies meeting this challenge? Tools that need to be put in place or enhanced. Meeting the challenges of more "on site" audits. Getting supplier buy-in. Coping with "rogue" suppliers. Areas  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...ompanies are coming under FDA investigation activities. A key area for maintaining cGMP compliance is Change Control. Yet it often is a companya ™s weakest link in compliance - proven by recent high-profile failures. Why so? FDA expectations? How are successful companies meeting this challenge? Tools that need to be put in place or enhanced. Getting personnel buy-in. Getting senior  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ...for FDA review. Areas Covered in the Session: * Key cGMP issues * Avoid complacency from past "good" FDA/ ISO audits * The desired response * How to respond now -- where to shift focus first * Where to direct scarce resources; A risk-based phased approach * How to address known problem areas during an Audit * Prove 'in control' * Maintain 'the edge'  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel ..., 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 approvals * Minimize nonconformances * Reduce rates of batch rework and rejections * Avoid product recalls * Identify and control the key contamination concerns for your company  more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel ...ification 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 * Minimize nonconformances * Reduce rates of batch rework and  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...d. This session will provide a focus on understanding the key considerations for the technical requirements of Part 11, to ensure system are compliant from a Part 11 technical perspective and, when coupled with sufficient procedural controls, will result in an overall Part 11 compliant deployment. Why should you attend: With the announcement in 2010 of a new Part 11 Inspection initiative,  more...

International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel ...ill not change * Who needs to comply * The four key principles of IFRS * How disclosure requirements will change * The new rules for assigning values to assets * The deadlines for adoption * How IFRS will affect SOX compliance * How these changes will benefit everyone Who Will Benefit: * Auditors * Accountants * Financial Managers *  more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa ...mentation commensurate with actual regulatory risks? The key is to plan for validation at the beginning of the project with a fundamental focus on the development of good user requirements. Such requirements can be utilized to determine the extent of validation and to target the testing effort on the critical, regulated functionalities of the PDMA system. The result is a validation effort  more...

Food Safety Management Systems - ISO 220002005 - Webinar By GlobalCompliancePanel ... Session: The following areas will be addressed: * Key terms and definitions * General Requirements * Documentation * Management Responsibility * Resource Management * Planning and Realization of Safe Products a flow diagrams, process steps and control measures * Hazard Assessment - Control Measures * Design and Redesign of HACCP Plan a Critical  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...* Tougher FDA and EU MDD Software V&V Expectations * Key COTS Software Apps V&V Requirements * Problem Areas * Product, Equipment/ Process, QMS and Apps Software and Part 11 Requirements * Realistic Limits of Apps Software V&V * Suggested Approaches * How to Implement, Execute and Document * Proper Risk Allocation of Scarce Resources Who Will Benefit:  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...le of the quality system & and regulatory loop Module 2: Key to success is management involvement, organizing, and training of all functions. Module 3: Management of Documentation and Records Module 4: Design Control Module 5: Facilities, Equipment & Environment Module 6: Material a Purchasing Controls-Specification, Qualification and Control of Suppliers, and controlling incoming  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...trols. FDA provides guidance and this course will address key resources when making critical decisions. Objectives: * Know the differences between the Traditional, Special and Abbreviated submissions * Understand Substantial Equivalence and how it is applied * Who is required to submit the application to FDA * Where to submit the 510(k) and what to expect with 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...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...res. Areas Covered In the Session: * Review the key provisions in the updated FDA guidance on medical device tracking * Understand the regulatory expectations for device tracking * Identify new terms and criteria * Understand the statutory criteria and what changed * FDA has issued orders to manufacturers who are required to track various implantable devices *  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ... Demographic Overview o Regulatory Framework: Key Agencies Involved / Reporting Structure o Recent Changes to MHLW / PMDA to Speed Review + MHLW (Ministry of Health, Labour and Welfare) + PMDA (Pharmaceutical and Medical Device Agency) + PAFSC (Pharmaceutical Affairs and Food Sanitation Council) o Patents and  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane ...eviations and violations and these will be discussed. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. To do this is ethical research. TO not follow the protocol is folly. Why Should You Attend: Protocol Deviations and Violations are one of the most common problems identified by FDA Investigators and is a main reason for the  more...

The Drug Development Path - From RD to Commercialization - Webinar By GlobalCompliancePanel ...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 in isolation, but must collaborate extensively to  more...

Auditing API Manufacturers and Suppliers - Webinar by GlobalCompliancePanel ... signs of weakness or deviations that are not obvious are key to a good audit. Developing that talent and utilizing it are vital to the success of an audit and the auditor. Being able to discover "the smoking gun" is a key talent of a great auditor. It is always easy to criticize after a problem causes a serious issue . . . it is difficult to see the problem coming and alerting people to its  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...

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...

Food Traceability Program and Efficacy Verification - Webinar by GlobalCompliancePanel Product traceability requirements for meeting Food Safety and Quality standards as required by BRC fundamental clause 5. 0, SQF item 4. 5, 9 CFR will be covered. The purpose of traceability and its value to the brand will be explored. The resources necessary to achieve an effective result will be presented. A customer perspective on the importance of product traceability from a customer  more...

Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel ...ng in a consistent and compliant state of control. The key to a successful audit is being able to communicate how your quality systems assure this state of control. However, the arrival of an investigator for an inspection can still be an intimidating experience. The inspection can be less traumatic if the site and its personnel are properly prepared for the inspection and the  more...

Robust Process Validation for Medical Devices - Webinar by GlobalCompliancePanel ...understanding of the regulatory intent of validation, the key for a robust process validation is the use of six sigma techniques and risk management. The rigor of a validation should be tied to the individual risk assessments of your products Critical Quality Attributes laid out in your design controls. Using the GHTF Process Validation Guidance document as a backdrop, this seminar will  more...

Key Modules of an Effective CAPA SOP - Webinar by GlobalCompliancePanel This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs, especially CAPA. It will examine how these goals of the Agency have translated into action in the past half year, with trends evident in 483 observations and Warning Letters. A key to effective relations with the FDA is the emphasis  more...

Conduct Your Own Risk Assessments Following ISO Standard 3100031010 It is essential for any organization to first determine its risk appetite and then to conduct its own self assessment as to its actual risk exposure. The new ISO risk standards provide a straight forward method that is suitable for larger and smaller organizations alike. Aligning your risk appetite with your actual risk exposure can help rationalize and prioritize key business opportunity  more...

Maintenance Management Online Certificate Course The Online Certificate Program in Maintenance Management consists of three modules, which will help you evaluate your operation; plan, coordinate and schedule maintenance; and properly use preventive and predictive maintenance in your operation. The program is designed for all types of maintenance environments including refineries, chemical plants, factories, mines, large buildings, organizations  more...

Business Broker Training Webinar ...ation * We will generate you buyers after launch - a key component to our NO COLD CALLING system * We will include you in our business broker network for networking and leads * Experience behind your training as we have trained 700 business broker since 2001 * NO cold calling - our systems get the most motivated contacting you * No commission splits or ongoing training  more...

Records Management 1 - Its A Lot More Than Filing - On-Demand Webinar ... profession. Start to understand the terminology and the key components such as classification schemes, retention schedules, and the management of email and disaster recovery. Michael Oa ™Shea has been involved in Records and Information Management consulting for over 20 years. He is one of the most respected international experts in traditional and emerging forms of information  more...

Tax Lien Investing Webinar- Series I Gain a clear understanding of the advantages and risks associated with real estate tax liens and/ or real estate tax deeds with expert help from Howard Liggett during this 90-minute online Webinar training presentation. He will discuss the ins-and outs of tax sale investing, including key differences between tax liens and tax deeds.  more...