Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971:2009 Requirements

MessageThis Webinar is over
Date May 21, 2014
Time 10:00am
Cost $195.00
Online
Overview:
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.

 


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