Master Validation Plan - The Unwritten Requirements

Master Validation Plan - The Unwritten Requirements is a webinar that covers topics such as:

  • The Master Validation Plan and its structure
  • Verification or Validation - Recent regulatory expectations
  • Process / Equipment / Facility Validation including FDA`s recent guidance
  • Product Validation - how it differs from process / equipment V&V
  • How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)
  • When and How to use DQ, IQ, OQ, PQ, or their equivalents
  • Incorporating 21 CFR Part 11 requirements
  • The 11 key documents for software validation
  • Approximately two 10 minute breaks during the webinar, with Q&A
  • Suggested "test case" formats

Master Validation Plan - The Unwritten Requirements brings together:

  • Supplements
  • Senior Management in Drugs, Devices, Biologics, Dietary
  • RA
  • QA
  • Engineering
  • R&D
  • Operations
  • Production
  • Consultants,Others tasked with Product, Process, Software Validation Responsibilities

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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