Drafting a Software V&V Documentation Package and Protocol

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:

• As-Product;
• In-Product;
• In Production and Test Equipment; and
• The Quality System.

• 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
• Quality Systems Personnel / QAE
• R&D and Engineering Staff
• New Product Development Personnel
• Validation Technicians
• IT Department
• Medical Device, Equipment / Process SW Programmers