Master Validation Plan - The Unwritten Requirements

Topics

• 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

Who should Attend

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