The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.
This webinar will address the use of the FDA, DAMP, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, to structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if “risk-based”. How can this be realistly accomplished.
This webinar will address software that is:
- In Production and Test Equipment; and
- The Quality System
A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process.
- Verification or Validation
- Current Regulatory Expectations and “Hot Buttons”
- The Project Validation Plan
- Product and Process / Equipment Software V&V
- When and How to Use DQ, IQ, OQ, PQ
- GAMP Considerations
- The FDA’s 11 Key Elements
- White Box and “Black Box” Validations
- Senior management, Project Leaders, Internal / External consultants
- Mid-level Management and Supervisory Personnel
- Regulatory Affairs Departments
- Quality Systems / QAE Departments
- R&D Departments
- Engineering Departments
- New Product Development Departments
- Validation Technicians
- IT Departments
- Medical Device, Equipment / Process SW Programmers