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 industry software
This webinar will address the use of the FDA, GAMP
The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if “risk-based”. How can this be done in the "real world". This webinar will address software that is:
3.Process and/or In Production and Test Equipment; and
4.The Quality System / CGMPs.
A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process.
• A quick review of Internet forums will show much confusion about the subject.
• The U.S. FDA rightly recognizes that virtually all software quality problems occur in the design, testing
• Effective and
• Verification or Validation -- FDA Expectations
• The Project Validation Plan
• An FDA-accepted Documentation "Model"
• Product and Process / Test / Facilities / Equipment Software V&V
• When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
• The FDA’s 11 Key V&V Documentation Elements
• “White Box” and “Black Box” Validations
• GAMP® / Other Considerations
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 in Drugs, Devices, Combination Products, Biologics, Dietary Supplements
• QA / RA
• Software development, programming, documentation, testing teams
• Consultants; others tasked with
NOTE: GAMP® is a registered trademark of ISPE. To learn more about GAMP®, visit www.ispe.org