Drafting a Software V&V Documentation Package and Protocol
Duration : 90 Minutes
John E. Lincoln,
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide. He specializes in quality assuranc Read more
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
A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process.
Course Outline:
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• 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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
