Overview:
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:
- As-Product
- In-Product
- In Production and Test Equipment
- 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:
- 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
Who Will Benefit:
- 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