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:
The U.S. FDA has stated that software validation can only be risk-based. This applies to Software:
- As-Product
- In-Product
- In Production and Test Equipment
- The Quality System
Areas Covered in the Session:
- 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
Speaker
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.
Who Should Attend
- 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
