Validation Planning to Meet US FDA and ISO 13485 Requirements
This FDA validation training will guide you through the validation planning which required meeting the US FDA & ISO 13485 Requirements.
Description
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. Also: 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, budgets, time). 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 are considered.
Areas Covered in the seminar:
- Verification or Validation -- Recent regulatory expectations.
- The Master Validation Plan.
- Product Validation – how it differs from Process / Equipment V&V.
- Process / Equipment / Facility Validation.
- When and How to use DQ, IQ, OQ, PQ.
- How to use your Risk Management Tools (per ISO 14971) – expand or contract the validation templates.
- The 11 “must have” elements of software validation.
- “White box” and/or “black box” and some test case suggestions.
Who will benefit:
- Senior management, project leaders
- Regulatory affairs
- Quality systems personnel
- R&D and engineering staff
- All charged with new product development, regulatory submissions, initiating / overseeing company-wide V&V planning, using a risk-justified approach.
- CAPA and P&PC personnel desiring to minimize post-production / life cycle and other costly problems.
Instructor Profile:
John E. Lincoln, consultant, has successfully designed, written and run all types of qualifications / validations, which have passed FDA audit or submission review, and have been 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 28 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, the Journal of cGMP Compliance, and past training chair - Intermountain Biomedical Association), and publishes a newsletter. He is a graduate of UCLA.
