This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.

The U.S. FDA has stated that software validation can only be risk-based. This applies to Software:

  • As-Product
  • In-Product
  • In Production and Test Equipment
  • The Quality System

A manufacturer is responsible to identify those risks, and take reasonable steps to address them in the software validation process. The FDA, GAMP and others provide guidance in the methodology and documentation to achieve this. Consideration of the principles in ISO 14971 can assist in providing an acceptable vehicle by which to perform and document risk-based software V&V.

Webinar Takeaway

  • Verification or Validation - Current Regulatory Expectations
  • The Project Validation Plan
  • Product Software Validation and Process / Equipment Software Validations - how they differ
  • When and How to Use DQ, IQ, OQ and PQ
  • ISO 14971:2007 Issues
  • GAMP Guidance
  • The 11 Key Elements of the Software V&V Model
  • "White box" and "Black box" Validations
  • 'Real World' Considerations

Who Will Benefit

  • Senior Management, Project Leaders
  • Internal / External Auditors and/or Consultants
  • Regulatory Affairs
  • Quality Systems Personnel / QAE
  • New product development, Marketing and R&D
  • Software Product and Process / Manufacturing Engineering Staff
  • Document Control
FDA Faculty John E. Lincoln

Faculty John E. Lincoln

Medical Devices / Regulatory Consultant; also pharma and dietary supplements

Saint George, Utah

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln 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 / CGMP audits and 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. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

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