FDA`s 21 CFR Part 11 Add-on Inspections

FDA`s 21 CFR Part 11 Add-on Inspections is a webinar that covers topics such as:

  • The proven V&V 11-element "model" – useful for all software V&V
  • 21 CFR Part 11, Electronic Records / Electronic Signatures – What it is and what it isn’t?
  • "Risk Based" – what it means in SW V&V and how it should be used
  • Developing test cases / scripts from Part 11
  • Insights on Cloud issues and Agile issues
  • Why Part 11 violations seldom show up directly on 483’s, but are there nonetheless

FDA`s 21 CFR Part 11 Add-on Inspections is intended for:

  • Middle management
  • Senior management
  • Engineering
  • R&D
  • QA / RA
  • Software
  • Operations
  • Manufacturing
  • CGMP instructors
  • Consultants
  • All personnel especially involved in product, process, validations, cGMP responsibilities

Future Events

FDA`s 21 CFR Part 11 Add-on Inspections 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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