Validation for FDA and ISO 13485 Compliance: Pack of Two Courses
From Medical Devices
Computer system validation and risk-based verification and validation planning to meet US FDA and ISO 13485 requirements
This pack of two training courses provides 2 hours of training on Computer system validation and risk-based verification and validation planning to meet US FDA and ISO 13485 requirements.
Module 1: Catching Up on Computer System Validation: Meeting FDA and ISO 13485: 2003 Requirements
Many regulated companies are still using unvalidated computer systems. Computer system validation is required by the FDA as well as ISO 13485: 2003. Medical device companies must transition to the 2003 version of 13485:2003
This presentation will review the FDA and ISO requirements for computer system validation and describe methods for meeting those requirements. Emphasis is placed on applications currently used in production and quality systems, such as document control, ERP, complaint, and QA systems, and manufacturing execution systems.
What Attendees will Learn
What I have to validate to meet FDA and ISO 13485 requirements ? ,Why validation makes good business sense? , The top 11 errors in computer system validation, What procedures are required and where to get them? , What approaches you can use: prospective, concurrent, and retrospective, How to validate new systems with a prospective validation process?, How to validate existing systems using a combination of concurrent and retrospective validation?, What are the minimum deliverables that I must create ?
Instructor Profile: Tim Stein, Ph.D., is the founder and CEO of Business Performance Associates, Inc. (BPA), a consulting firm that specializes in both quality systems for biomedical companies and computer system validation. Tim is the author of Computer System Risk Management and Validation Life Cycle which is scheduled for release in April 2006 by Paton Press. Tim has written a set of policy and procedure documents and templates for computer system validation that are available through ComplianceOnline.
Module 2: Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
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.
Attend this seminar for learn key success factors for risk-based V&V planning to meet FDA and ISO 13485 requirements. It will cover creating a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, for development of meaningful product validations; the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources (personnel, budget, time); developing a matrix simplifies 'as-product', 'in-product', process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 will also be discussed.
Instructor Profile: John E. Lincoln, consultant, has successfully designed, written and run all types of qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control projects; with over 24 years of experience, primarily in the medical device industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP Compliance, and Intermountain Biomedical Association), and publishs a newletter. He is a graduate of UCLA.