Validation for FDA and ISO 13485 Compliance: Pack of Two Courses

Module 1: FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance

This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.

Areas Covered in the Webinar:

• Learn how to identify “GxP” Systems
• Learn about FDA’s current program for modernization of technology, and how this will impact industry
• Learn about FDA’s Technology Modernization Action Plan (TMAP), including what work is underway and what is planned in the near term
• Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements
• Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
• We will discuss cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively
• Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures, including ways to improve efficiency and effectiveness
• Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner
• Learn how to assure the integrity of data that supports GxP work, despite changes and advances in new technology
• Discuss the importance of “GxP” documentation that complies with FDA requirements
• Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
• Know the regulatory influences that lead to FDA’s current thinking at any given time
• Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
• Q&A

Instructor Profile: Carolyn Troiano, has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

Module 2: Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements

This webinar will review company's Validation Master Plan for major cGMP deficiencies. Review hazard and risk management tools per ISO 14971 and ICH Q9. Utilize sufficient or targeted risk-based V&V planning. Use the VMP and Product Risk Management Files to develop meaningful product and process validations. Address "worst case allowables". Also the role of the individual V&V plan, and different protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents. The models presented simplify "as-product", in-product", process and equipment, software VT&V, assuring key FDA requirements are not overlooked. V&V of a company's QMS and 21 CFR Part 11 are considered.

Areas Covered in the Webinar:

• Verification or Validation -- Current regulatory expectations.
• Purpose, format, contents and execution of the Validation Master Plan and the Individual V&V Plans.
• When / how to use the DQ, IQ, OQ, PQ, or their ASTM E2500 equivalents.
• What is "risk-based"?
• Using the Risk Management tools of ISO 14971 and ICH Q9.
• The 11 Elements of the FDA’s software / firmware VT&V "Model".
• Part 11 and QMS software V&V.
• Key recent compliance problems and their resolution.

Instructor Profile: John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years’ experience in U.S. FDA-regulated industries, 23 as an independent consultant. John has worked with companies from start-up to Fortune 100, worldwide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, submissions, process / product / equipment including QMS and software validations, ISO 14971 product risk management and human factors files / reports, Design History Files, Technical documentation. He's held positions in Engineering, QA, QAE, RA, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, written numerous chapters for books on validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.

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