Calibration and Validation of Equipment

Description:

Review a company's calibration, verification, and validation system against the critical requirements of the CGMPs and risk management. Starting with the required but often neglected Master Validation Plan, evaluating ISO 14971 and ICH Q9 risk analysis and documentation requirements in hazard analysis and product risk management, and a solid calibration program allows the development of meaningful product quality-specific equipment validations. Consider Human Factors / Use Engineering elements where required. A variety of V&V protocols will be presented and discussed, including how to employ equipment test cases in IQs, OQs, and PQs, or their equivalents. The QSR / QMSR / ISO 13485 and 21 CFR Part 11 and cybersecurity are also discussed and where they are to be incorporated in validation.

Why Should You Attend:

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in verification and validations. Validation starts with calibration to NIST standards (or similar) of key instrumentation/gauges. V&V must be based on patient / user safety / risk. And all software must be validated per the FDA. A field-tested (FDA and Notified Body) software V&V "model" will be presented. Critical components of product risk management from ISO 14971 (and ICH Q9) will be presented.

Areas Covered in the Webinar:

Participants will learn how an effective calibration and validation system is a critical requirement of a risk-based approach to CGMP compliance and product safety. Issues to be covered include:

• Calibration requirements
• Prospective, Concurrent, or Retrospective Validations
• Assurance of product quality from CGMP-compliant validation
• Learn methods for developing validations and best practices.
• Regulatory requirements for validation
• "Working definitions" for V&V and DQ, IQ, OQ, and PQ
• Product, Process, Production / Test Equipment V&V
• The Validation Master Plan
• Compile a Compliant V&V Test Report with Various Test Cases

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to review and modify their Calibration and Equipment Validation Planning and Execution / Documentation. While this information is focused on Medical Devices, its principles apply to personnel / companies in the Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• Engineering, including Software
• All personnel involved in verification and/or validation planning, execution and documentation.

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 42 years experience in U.S. FDA-regulated industries, 27 of which are as an independent consultant. John has worked with global companies to resolve regulatory issues, lead validations (hardware and software) and implement QMS/RA systems. He has published numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on Validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.

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