The Most Common Problems in FDA Software Validation & Verification
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This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
The U.S. FDA has stated that software validation can only be risk-based. This applies to Software:
3) In Production and Test Equipment, and
4) The Quality System.
A manufacturer is responsible to identify those risks, and take reasonable steps to address them in the software validation process. The FDA, GAMP and others provide guidance in the methodology and documentation to achieve this. Consideration of the principles in ISO 14971 can assist in providing an acceptable vehicle by which to perform and document risk-based software V&V.
Areas Covered in the Session:
Who Will Benefit:
- Verification or Validation – Current Regulatory Expectations
- The Project Validation Plan
- Product Software Validation and Process / Equipment Software Validations – how they differ
- When and How to Use DQ, IQ, OQ and PQ
- ISO 14971:2007 Issues
- GAMP Guidance
- The 11 Key Elements of the Software V&V Model
- "White box" and "Black box" Validations
- 'Real World' Considerations
- Senior Management, Project Leaders
- Internal / External Auditors and/or Consultants
- Regulatory Affairs
- Quality Systems Personnel / QAE
- New product development, Marketing and R&D
- Software Product and Process / Manufacturing Engineering Staff
- Document Control
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have 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, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.