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The Most Common Problems in FDA Software Validation & Verification

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


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

Course Objetives:

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.

Course Outline:

• 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

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 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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

Contact Us



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