Validation Planning to Meet US FDA and ISO 13485 Requirements

Why Should You Attend:

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 Webinar:

• 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.