• 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
The verification and validation of medical industry software are coming under increased scrutiny by the U.S. FDA.
This webinar will address the use of the FDA, GAMP®, 21 CFR 11, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, and their real-world implementation. If will focus on the 11 key software documents from an FDA Guidance Document.
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.
• Senior management in Drugs, Devices, Combination Products, Biologics, Dietary Supplements
• QA / RA
• Software development, programming, documentation, testing teams
• Consultants; others tasked with product, process, electronic records software V&V responsibilities
The software has become pervasive in medical devices themselves, and in the controlling, running, and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics, or dietary supplements industries.
• A quick review of Internet forums will show much confusion about the subject. Software is being developed for medical imaging and even thought control of computers. It is increasingly being used for e-records and e-signatures.
• The U.S. FDA rightly recognizes that virtually all software quality problems occur in the design, testing, and validation phases since the replication of software are relatively defect-free. Regulatory auditors are more comfortable with delving into software issues.
• Effective and real-world software V&V is even more important in today’s resource-constrained industrial environment. This discussion will focus on a preferred U.S. FDA documentation "model" in various software/firmware applications, including ERP, in-device, as-device, process/equipment control, and cGMP data / 21 CFR Part 11 applications.
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years experience in U.S. FDA-regulated industries, 19 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.