This risk-based software V&V training will guide you through 11 'must have' elements of software validation and how to use your Risk Management Tools (per ISO 14971:2007).
One major failing is lack of sufficient or targeted risk-based software V&V planning. 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.
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.
- White box and/or 'black box'.
- 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.
- NOTE: GAMP® is a registered trademark of ISPE.
Course Provider
John E Lincoln,
