Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971:2009 Requirements - Webinar by GlobalCompliancePanel 2010

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must be considered. Areas Covered in the Session:

• Verification or Validation - Recent regulatory expectations
  
• The Master Validation Plan
  
• Product Validation - how it differs from process / equipment V&V
  
• Process / Equipment / Facility Validation
  
• When and How to use DQ, IQ, OQ, PQ
  
• How to use your Risk Management Tools (per ISO 14971)
  
• The 11 "must have" elements of software validation
  
• 21 CFR Part 11 issues
  
• Possible "test case" formats.

Who Will Benefit:

• Senior management, project leaders
  
• Regulatory Affairs
  
• Quality systems personnel
  
• R&D and engineering staff
  
• All charged with new product development, regulatory submissions, initiating / overseeing company-wide V&V planning, using a risk-justified approach
  
• CAPA and P&PC personnel desiring to verify proposed solutions and minimize post-production / life cycle and other costly problems.