C4A – Verification vs Validation-Product, Process or Equipment and QMS Software

August 26, 2020 @ 10:00 am – 11:00 am


By John E Lincoln


The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA. 

This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,”Electronic Records”/”Electronic Signatures”, IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, 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 done in the “real-world”. 

This webinar will address software that is:

  • As-Product
  • In-Product
  • Process and/or In Production and Test Equipment and
  • The Quality System/CGMPs

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

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