This FDA compliance training will guide you through Software Verification and Validation process in FDA-Regulated Industries. U.S. 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 software V&V. Starting with a Project Validation Plan, evaluating its elements against ISO 14971:2007 hazard analysis/risk management, allows development of meaningful product/process 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). Two matrices/models simplify regulatory requirements for “as-product”, “in-product”, process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. QMS and 21 CFR Part 11 require yet another approach.
Some 'real world' test case examples.
Areas Covered in the seminar:
- Verification or Validation - Recent regulatory expectations.
- The Project Validation Plan.
- Software Product Validation - how it differs from process/equipment V&V.
- When and How to use DQ, IQ, OQ, PQ.
- How to use your Risk Management Tools (per ISO 14971:2007).
- GAMP guidance.
- The 11 'must have' elements of software validation.
Some 'real world' test case examples.
Who Will Benefit:
- All management levels; project leaders
- Regulatory affairs
- Quality systems personnel
- R&D and engineering staff
- All charged with new product/pilot development, regulatory submissions, initiating/overseeing company-wide software/V&V planning, using an ISO 14971:2007-based risk-justified approach.
- CAPA and P&PC personnel desiring to minimize post-production/life cycle and other costly problems.
Course Provider
John E Lincoln,
