Software Verification and Validation Planning to Meet FDA Requirements 2013

  • 24 Apr 2013
  • Webinar

Description

Software Verification and Validation Planning to Meet FDA Requirements is a webinar that covers topics such as:

  • Current Regulatory Expectations and Recent Audit "Hot Buttons"
  • Verification or Validation
  • Product and Process / / Facilities / Equipment Software V&V
  • The Project Validation Plan
  • GAMP / Other Considerations
  • When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
  • CFR Part 11, QMS, Electronic Records / E-Signatures
  • The FDA’s 11 Key V&V Documentation Elements
  • "White Box" and "Black Box" Validations

Software Verification and Validation Planning to Meet FDA Requirements brings together QA, Senior management in Drugs, Devices, Biologics, Dietary Supplements, R&D, RA, Production, Engineering, Consultants; others tasked with product, process, electronic records software V&V responsibilities and Operations.

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Important

Please, check "Software Verification and Validation Planning to Meet FDA Requirements" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Healthcare, Medical device, Pharma
Industry: Food & Beverages

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