Software Verification and Validation For FDA-Regulated Industries
Instructor:
John E Lincoln
Product ID: 701135
- Duration: 60 Min
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.
John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and 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 24 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 and the Journal of cGMP.
More Training By Experts
- 10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance
- Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
- Change Control - Implementation and Management
- Validation for FDA and ISO 13485 Compliance: Pack of Two Courses
- Medical Device QSR (21 CFR Part 820), Design Control, Hazard Analysis Under ISO 14971 and ICH Q9: Pack of 3 Courses
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