Webinar on Robust Verification and Validation

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Robust Verification and Validation
Product ID FDB1109
 Category Food, Drugs Biologics
Scheduled On Wednesday, July 30, 2014 at 1300 Hrs
Duration 90 Minutes
Speaker John E. Lincoln

To register for this webinar please visit
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• Webinar Description

This 90 minute in-depth webinar discusses the FDA
Warning Letters and recent high-profile recalls
indicate major cGMP deficiencies in big name
device and pharma companies, many going back to
insufficient, poor or non-existent VV
planning. And now the FDA is taking an even
tougher stance. Why do companies need robust
VV? What are the "must have" elements from  the
cGMPs? How do ISO 14971 and ICH Q9 for hazard
analysis and product risk management factor in
and assist to allocating limited company
resources? How can these be integrated into the
company's quality management system?

Area Covered In The Session

• Robust Verification and Validation -- Recent
  Regulatory requirements.
• The Master Validation Plan(s).
• Individual Verification and Validation Plans and
  their execution.
• Product Verfication Validation.

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• Process and Equipment Verfication Validation,
  including Software.
• QMS VV and 21 CFR Part 11.
• When and How to Use DQ, IQ, OQ, PQ, or ASTM E2500
  Equivalents.
• The 11 Elements of the FDA's Software VV
  "Model".
• Incorporate the Hazard Analysis / Risk Management
  tools of ISO 14971 and ICH Q9.
• Avoid recent compliance problems.

• Who Will Benefit

• This webinar will provide valuable assistance to
  all regulated companies that need to review and
  modify their company's planning and execution of
  verification and validation. Its principles apply
  to personnel / companies in the Medical Devices,
  Pharmaceutical, Diagnostic, and Biologics fields.
  The professionals who will benefit include all
• Senior management
• Middle management
• RD
• Engineering
• Software
• QA / RA
• Manufacturing
• Operators
• Consultants
• cGMP instructors

• Speaker Profile

John E. Lincoln is a medical device and
regulatory affairs consultant. He has helped
companies to implement or modify their GMP
systems and procedures, product risk management,
U.S. FDA responses.
To know more visit https//compliancetrainings.co
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