Benefit Web-based Seminars

ITIL v3 Foundation Virtual Classroom The ITIL Foundation Course is a 3 day virtual classroom course for a truly engaging and interactive course experience. The main benefit of this course is that it's travel-free and flexible. The course will take place in July, September and December. Enroll quickly, places are limited.  more...

Health Information Technology Introduction ...and other health information technology systems will also benefit from our sessions to obtain basic knowledge to move forward in their project. Although there are no educational requirements for taking our workshops or courses, it is recommended that individuals either have healthcare experience and participate in electronic health record (EHR), and/ or health information technology (HIT)  more...

Health Information Technology Systems ...and other health information technology systems will also benefit from our sessions to obtain basic knowledge to move forward in their project. Although there are no educational requirements for taking our workshops or courses, it is recommended that individuals either have healthcare experience and participate in electronic health record (EHR), and/ or health information technology (HIT)  more...

Call Center Workforce Management Certification - Live Online - August 1-3 2012 ...orecasts, schedules, and budgets. We include lessons that benefit attendees from any sized organization, large and small, with real-world examples of solutions that work in practice - not just theory. When this learning is expanded to workforce management, the focus extends to forecasts, schedules and budgets. Participants will come to understand the processes that make up the foundation of an  more...

Call Center Workforce Management Certification - Live Online - April 4-6 2012 ...orecasts, schedules, and budgets. We include lessons that benefit attendees from any sized organization, large and small, with real-world examples of solutions that work in practice - not just theory. When this learning is expanded to workforce management, the focus extends to forecasts, schedules and budgets. Participants will come to understand the processes that make up the foundation of an  more...

Comprehensive Silverlight 2.0 Training In this Silverlight training course students will build an application through a series of hands-on labs. The first 3 days of the course focus on the basics of Silverlight and supporting technologies. The final 2 days focus on more advanced Silverlight-specific topics.While this course targets Silverlight developers, designers looking to utilize Silverlight and Microsoft  more...

Oracle Database 10g: Administration Level I In this database administration course students gain the skills necessary for basic day-to-day administration of an Oracle10g database. This Oracle training class is the starting points for Oracle database administrators and also sets the foundation for advanced administrator training and certification. The class target audience is Oracle database administrators.  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...

Advanced Oracle SQL Training on Oracle 11g/10g The primary objective of this Oracle training class is to consider advanced subjects and techniques pertaining to the SQL database language. Even professionals experienced in other implementations of the industry-standard SQL language will benefit from the advanced and Oracle-specific features of SQL discussed in this course.  more...

MOC 6421 - Configuring and Troubleshooting a Windows Server 2008 Network Infrastructure This Windows Server training class provides students with the knowledge and skills to configure and troubleshoot a Windows Server 2008 network infrastructure. Students will learn to implement and configure secure network access and implement fault tolerant storage technologies. Students will gain an understanding of the network technologies most commonly used with Windows Server 2008 and  more...

Introduction to Microsoft Silverlight In this Silverlight training course students will build an application through a series of hands-on labs. The course focuses on the basics of Silverlight and supporting technologies.While this course targets Silverlight developers, designers looking to utilize Silverlight and Microsoft Expression Suite will also benefit from the knowledge gained.  more...

Advanced Microsoft Silverlight Training This advanced Silverlight training course focuses on more advanced Silverlight-specific topics. While this course targets Silverlight developers, designers looking to utilize Silverlight and Microsoft Expression Suite will also benefit from the knowledge gained.  more...

Certified Sustainability Administrator- Training Start your path to a new career as a Certified Sustainability Administrator (CSA). If you are employed and will be taking on the role of a Sustainability Administrator at your work, or if you are seeking employment to be hired as a Sustainability Administrator or a Green Officer type of job, our training program will benefit you immensely  more...

How to Conduct an Effective Monthly Variance Review Meeting It has been said that difference between a GOOD plant manager and a GREAT plant manager is often in how operating variances are routinely addressed and how corrective actions are routinely executed. Great plant managers always conduct a routine a Variance Review Meetinga each month, challenging their direct reports to explain all significant variances from plan. These variances are usually,  more...

Early Intervention Field Trauma Training ... well as mental health and health care professionals will benefit from Field Trauma training. This is an entry-level program and no pre-requisites are required to receive the Field Trauma designation other than successful course completion. Participants will learn about on-site responding and learn how to respond to a critical event and aid those requiring psychological first aid. Field  more...

Demystifying the Calculations of Efficiency Utilization and Productivity ...ed from the formulas can be altered and how companies can benefit from the CORRECT understand of these terms. We will clearly show participants HOW to calculate these values and WHEN to use the results of the measurements. Though this webinar presents a seemingly simple topic, the correct understanding and use of efficiency, utilization and productivity can create a profound impact on how  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...

Calculating Overtime Correctly - Webinar By TrainHR ...retionary bonuses, on-call pay, shift differentials, cash benefit payments from Section 125 Cafeteria Plans, the list goes ona And that's just computing the regular rate - we havena ™t even touched overtime yet! Well, what happens if ita ™s not correct? Nobody pays attention do they? According to the Department of Labor, 300 new wage and hour investigators were hired in  more...

Introduction to Contamination Control Master Plans - By GlobalCompliancePanel Why you should attend: Manufacturers of human medical products have established myriad control programs to comply with FDA regulations regarding control of product contaminants. However, due to variable emphasis being placed on each of these control elements by FDA auditors, most manufacturers have developed their programs in a piecemeal fashion. Thus, each element in a manufacturer's control  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...

Practical Laboratory Statistics 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 equipment.  more...

Validating Radiation Sterilization for Medical Device Industries by gcp Gamma and E-Beam radiation has used for sterilization of medical devices for over 50 years. Both methods are validated following the same principles and standards. This webinar will provide an overview of the requirements to validate medical devices for both Gamma and E-Beam sterilization. Validation is based on the international standard ISO 11137-1: 2006 and ISO 11137-2: 2006. In this one  more...

Breakthrough Performance Management that is Practical Effective and User-Friendly ...ers who are fully capable of producing good outcomes, but benefit from leadership and support that helps them take action in the best possible manner. The employee and manager form a performance partnership and jointly agree on the performance targets and the actions necessary to achieve them. Using a simple but effective protocol and checkpoints along the way, the manager is assured that the  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a This workshop helps HR professionals understand how to navigate the difficult and often murky challenge of dealing with "invisible disabilities." To make matters more confusion, the recent amendments to the A. D. A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues  more...

Document Retention and Destruction You should attend this webinar to be sure both you and your staff in charge of records understands the responsibility and importance of knowing and following proper procedures. When auditing how information is kept by Human Resource Departments, many questions come up regarding where records are kept, how long they should be kept and when and how they should be destroyed in order to stay in  more...

Preventing Harassment in the Workplace by TrainHR This webinar will concentrate on what is considered sexual harassment as well as covering other types of harassment in the workplace. It will review the laws protecting employees from harassment and the recourses employees have. It will define who is covered and describe the two main kinds of sexual harassment in the workplace. It will cover what should be in an effective Harassment policy, how  more...

Document Retention and Destruction by TrainHR You should attend this webinar to be sure both you and your staff in charge of records understands the responsibility and importance of knowing and following proper procedures. When auditing how information is kept by Human Resource Departments, many questions come up regarding where records are kept, how long they should be kept and when and how they should be destroyed in order to stay in  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...

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 ...ective 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. Learn also how the International Conference on Harmonization (ICH) has been the most outspoken as to what GCP is including a formal listing of the "Principles of GCP" and a definition that is clear. Covered also will be  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ...s, and Writing the Report * Revalidation Who Will Benefit: * Quality, quality control, regulatory, engineering, and manufacturing and IT staff working in the FDA regulated industry in the development and manufacture of medical products. * Interdepartmental functions associated with scaling up and commercializing a new medical product * Regulatory Affairs *  more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel Overview: Auditing an API CMO or any API supplier is a specialty that requires knowledge and experience that is gained through exposure to the unique attributes associated with API manufacturing. API manufacturing has similar regulatory GMP expectations as drug products, but not identical in is specific requirements and application. The nature of API manufacturing and its usual purification  more...

Designing a CAPA System that Meets and Exceeds Regulatory Requirements - Webinar By GlobalCompliancePanel Overview: CAPA is the most audited 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,  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 Overview: Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities. It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective  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 Overview: This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. 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  more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ...mplaint management system with investigations Who will benefit: This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. The employees who will benefit include: * All levels of Management for all departments and those who desire a better understanding * QA/ QC/ Compliance/  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel Overview: This webinar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U. S: "The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and  more...

How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel Overview: Many companies are confident that their record keeping 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  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 ... offer an introduction to cloud computing and explain the benefits of using a SaaS system. We will detail the differences between a Conventional Implementation and a SaaS Implementation Methodology. A SaaS CRM system will be utilized as an example to discuss what drives SaaS system compliance and how requirements can be limited to Customer specific configurations. The scope of the validation  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...* Supplier management and performance metrics Who Will Benefit: This seminar is designed for people in manufacturing who are involved in setting product specifications, setting up acceptance plans, performing acceptance activities, and supply chain management. Attendees should have knowledge of manufacturing process that includes acceptance activities such as incoming, in-process, and final  more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel Overview: This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature  more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel .... Why should you attend: This webinar will address the benefits of implementing a Test Management Tool to manage the validation life cycle, considerations for the implementation project of a Test Management Tool, Test Management Tool Operation/ Maintenance requirements and Automated Testing considerations. Areas Covered in the Session: * System Based Test Tools vs. Paper Based Test  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ... * The measures to ensure quality monitoring Who Will Benefit: This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry Conducting Clinical Trials including: * Senior Management * Project Managers * CRA Managers * QA/ Compliance persons * Principal Investigators and sub investigators * Clinical  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel ...t 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 recalls.  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ... 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 Overview: Laboratory equipment should be calibrated and/ or qualified to demonstrate suitability for the intended use. 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  more...

The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel ...the design. Emphasis is placed on enhancing the power and benefits of FMEA for your organization by avoiding common pitfalls and concentrating efforts toward the real value of the FMEA process. Areas Covered in the Session: * What is an FMEA o What are the components of an FMEA? * How should I use FMEA in performing risk management? * What are the problems with  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel Overview: 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: 2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to  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 Overview: This webinar will discuss 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  more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W ... Trends * Module 17 - Review and Wrap-up Who Will Benefit: * Quality, quality control, regulatory affairs, operations working in the FDA regulated medical products industry (Pharma & Device) in the design, scale-up, regulatory approval, commercialization, and maintenance of quality systems. * Suppliers providing materials and contractors supplying outsourcing s services to  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 Overview: This program will provide the content 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  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 ... 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 required content for a compliant business associate agreement will be presented. * Issues of how to assign liability and costs  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ...shamea on the Web * You will be provided tools and benefits including: o An understanding of the background of the Breach Notification Rule and what it calls for in the regulations. o Where to find the information and forms for filing breach notifications with HHS. o What goes into an effective breach notification policy? o How to prevent  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 Overview: The webinar examines critical parts of design control after product release including: design change control, design validation, and the Design History File. 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  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 Overview: This presentation will review the requirements for the Risk Management Plan and discuss practical methods for meeting the requirements. Examples of documentation of the Plan will be presented, including Risk Acceptability Criteria, risk review, verification activities, and information collection activities. While Risk Management Plans can be part of the Quality Plans for a product,  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 ...(USP and Ph. Eur.) * Acceptance criteria Who Will Benefit: Senior management and laboratory personnel responsible for the conduct of microbiological testing and microbial control strategies in manufacturing and product/ process development: * Microbiology * Quality Control * Quality Assurance * Manufacturing * Validation * Regulatory Affairs * R&D  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 ...ecruitment process and the importance of each Who Will Benefit: This Webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be: * Principal Investigators and sub investigators  more...

Understanding the Calibration Curve - Webinar By GlobalCompliancePanel Overview: This presentation will provide an overview of the rules and assumptions behind the calibration of analytical instruments. We will discuss how external standard, internal standard, and isotope dilution methods are designed, and learn the situations where each technique is the best option. Whether you use single point calibration, or linear regression, we will discuss the strengths and  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 Overview: This course provides regulatory/ 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  more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel ...ilize the QSIT approach in internal auditing. Who will benefit: During FDA inspections, several individuals from the organization work closely with FDA officials. For them and for senior management, understanding the intricacies of the methodologies used by the FDA is of high importance. This Webinar provides such an understanding. It will also benefit: * Top Management *  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel Overview: 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  more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel Overview: This interactive webinar begins with an overview of the FDA Inspection process. Preparation for the inspection in the months before, the immediate weeks before and on the day of the inspection will be discussed. The Inspection process will be reviewed followed by a detailed look at common focus area areas of Inspectors. Procedures to be followed after the inspection such as  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 Overview: This Interactive webinar will begin with an overview of the GMP/ GLP requirements for an Equipment system. The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/ GLP compliance will be reviewed. Why you  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl ...e establishmentsa ™ registration numbers Who will benefit: This webinar will provide valuable assistance and guidance to medical device firms, importers and those who need to register their device firms and list their device(s). The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding or a "refresh"  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ...ng * Review recent statistics and trends Who will benefit: This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement. The employees who will benefit include: All levels of management and departmental  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 ...hat such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its selection, audit, use and on-going relations with its suppliers of services and products / components. How can companies address the FDA's stated desire to require "on-site" audit of all Pharma suppliers? Expectations for  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 ...hat such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change control policies and systems. Change can be beneficial, but is often the cause of new and even worse problems than those the change was designed to eliminate. It can be the root cause of a major problem, cGMP "entropy".  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 ...records submitted to FDA in electronic format Who Will Benefit: Attendees should have knowledge of manufacturing and quality system processes. This typically includes: * Quality Engineers * Production and Process Engineers * Manufacturing Engineers * Design Engineers * Purchasing Managers * Purchasing Agents * Supplier Quality Engineers * Quality  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel ...d 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 ...ation 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 rejections  more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel Overview: Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that explores either natural variation or introduced variation in a process and shows that the process can consistently produce a quality product. Writing and executing good process validation can be a  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 ...ctions can be found so that you and your organization can benefit and profit more from the CAPA process and CAPA teams - and maybe more importantly have those outside the quality department more engaged and interested in participating in CAPA and continuous improvements * Q & A Who Will Benefit: * Quality Managers * Quality Engineers * Small business owners * CAPA  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ... o Some commonly asked questions by the inspectors and benefits of being compliant * Module 3 - Internal and External Auditing for Part 11 Compliance o Aspects of auditing for Part 11 compliance- starting at the audit program level and then going down on how to prepare for an audit to how to successfully execute the audit and follow up on the completed audit o CAPA  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 ...uality 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 PDMA requirements, it is important to understand what the  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 ...es to be proactive in reducing risk while increasing user benefits. How does this translate to common software applications programs, e. g., MS-Excel and MS-Word, or 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  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 ...d 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. Without passing scores on these audits, companies are losing current accounts and are denied access to new accounts and business. Many organizations  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 Overview: This presentation will explore FDA Corrective Action and 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  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ... * Preventive Action * Verification Who will benefit: The following individuals and disciplines will benefit from this webinar: * QA document reviewers * QA personnel responsible for reviewing investigations reports * QA personnel responsible for the deviation and investigations systems * Quality and Operations personnel responsible for investigations *  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel ...derations and requirements for foreign trials Who will benefit: This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials including: * Managers in Clinical Development and Project Leaders * Quality Assurance Managers and auditors * Clinical Research Associates * Clinical  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 ...C and Endotoxin as Microbial Count Correlates Who Will Benefit: This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for those in FDA, EMA, and AAMI regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. The employees who will benefit  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 Overview: This presentation will review the Medical Device Reporting regulations and common violations leading to Warning Letter filings by FDA. As part of the review, actual Warning Letter and FDA-483 citations of small and large medical device manufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information  more...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel Overview: While not captured in most audit reports, one of the biggest mistakes an organization can make is to have insufficient self 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  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ...n risk reduction based on supplier typologies Who will benefit: * Food supply chain buyers (farms, wholesalers and distributors, retailers, packers, restaurants, and processors) and corporate executives need to be updated and on top of how they can take some relatively simple steps to reduce risks associated with a food safety outbreak or recall. * The session is also a must for  more...

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel ...egulatory focus for Sites, Sponsors, and IRBs Who will benefit: This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials including: * Clinical Quality Assurance Auditors * Clinical Quality and Compliance Professionals * Clinical Research Associates (CRAs) * Project Managers  more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel ...nd Instruments - similarities and differences Who Will Benefit: 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. The employees who will benefit include:  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...nconforming, Investigations, and CAPA systems Who will benefit: * Quality, quality control, regulatory, engineering, and manufacturing and IT staff working in the FDA regulated industry in the development and manufacture of medical products. * Interdepartmental functions associated with scaling up and commercializing a new medical product * Suppliers and software vendors,  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...ny in this open-forum and interactive session Who will benefit: This course is appropriate to those involved in all aspects of the premarket notification, i. e., 510(k) process on behalf of medical device and In Vitro Diagnostic manufacturers. It is both a primer for personnel new to the FDA 510(k) process, or an excellent refresher course for those who need to revisit the basics and  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...gn/ process changes and DHF, DMR, DHR, and TF Who Will Benefit: This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. This typically includes: * Quality Managers/ Engineers * Production/ Process Managers/ Engineers * Manufacturing Managers/ Engineers * QA and QC managers, inspectors,  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 ...ew water system myths related to sanitization Who Will Benefit: This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for those in FDA, EMA, and AAMI regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. The employees who will benefit  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 ...mpact with user facilities and patient issues Who Will Benefit: This webinar will provide an overview and guidance to device manufacturers involved in medical device tracking activities. Employees who will benefit include: * All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the Medical Device Tracking  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ... o Professionalism in Regulatory Affairs Who Will Benefit: This course will also be useful for sales or general management personnel who need an overview of the Regulatory Compliance requirements within Japan and how best to consider the country into one's Business Strategy. * Regulatory personnel whose responsibilities require knowledge of Japan's regulatory environment. *  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 Overview: This webinar will examine the broad range of issues a company's senior management and QA/ RA need to consider 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)  more...

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach QSA to the Pharmaceutical GMPs - Webinar By Global ...will win the GMP battle-Quality or Compliance Who Will Benefit: * Quality Unit Supervisors/ Managers/ Directors * Manufacturing Supervisors/ Managers/ Directors * Support Functions to Quality or Manufacturing * Regulatory Affairs personnel responsible for GMP Compliance and filings * Support personnel responsible for GMP Related activities such as Calibration and  more...

Basics of OTC Drug Labeling Compliance - Webinar By GlobalCompliancePanel ...hat they're labeled properly with appropriate claims will benefit from this program/ webinar. It will provide background for OTC Drug labeling regulations and an understanding of how to comply with FDA requirements. Potential FDA enforcement actions regarding OTC drug labeling will also be covered. Areas Covered in the Session: * OTC Drug Labeling regulations: background and  more...

Introduction to Operational Risk - Webinar By GlobalCompliancePanel Overview: 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  more...

Through the Customer Eyes Tuesday Sept 28 2010 100 pm ET ...on program for customer service representatives that will benefit any employee who interacts with customers. Developed in cooperation with, and endorsed by, the International Customer Service Association, Through the Customer's Eyes will help you: Improve productivity. Increase employee retention. Implement consistent training. Create dependable service levels. Establish  more...