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

A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process.

Areas Covered in the Session : 

• 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

Who Should Attend:

• 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

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 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 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 published 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.