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IQ, OQ, PQ in the Verification and Validation Process

Duration : 90 Minutes

John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide.  He specializes in quality assuranc Read more

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 product / equipment / process V&V requirements and execution. And now the FDA is taking an even tougher stance.

Why do companies need robust V&V?

What are the “must have” elements from  the cGMPs and best practices?

How do you define and use IQ, OQ, PQ, or their equivalents?

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?

Course Objectives:

This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures.

Course Outline:

• IQ, OQ, and PQ, major components of robust Verification and Validation V&V programs – Regulatory requirements

• The Master Validation Plan(s)

• Individual V&V Plans and their execution

• Product Verification and Validation

• Process and Equipment V&V; including software

QMS V&V and 21 CFR Part 11

• When / How to Use DQ, IQ, OQ, PQ, or ASTM E2500 Equivalents

• The 11 Elements of the FDA’s Software VT&V “Model”

• Incorporating the Hazard Analysis / Risk Management tools of ISO 14971 or ICH Q9

• How to Avoid recent compliance problems

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

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, based on a proper understanding of the roles of IQ, OQ, and PQ, or equivalent terminology. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. 

• Senior management

• Middle management

• Research & Development

• Engineering

• Software

• QA / RA

• Manufacturing

• Operators

• Consultants

• cGMP Instructors

• All personnel involved in verification and/or validation planning, execution and documentation.

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

Contact Us

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