Validation Planning to Meet US FDA and ISO 13485 Requirements

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.

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