Drafting a Software V&V Documentation Package and Protocol
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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.
Areas Covered in the Session:
Who Will Benefit:
- 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
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.