IQ, OQ, PQ in the Verification and Validation Process
Develop a Master Validation Plan and defensible IQ, OQ, PQ protocols aligned with FDA cGMP, ICH Q9, ISO 13485, and ISO 14971 risk management standards.
Instructor
John E. Lincoln
FDA Regulatory Affairs, Design Control & QMS Expert
What You'll Learn
About the event
About this event
This course guides participants on how to develop or improve DQ, IQ, OQ, and PQs and the Master Verification and Validation Plan that meets risk requirements under U.S. FDA cGMP, ICH Q-series, and ISO 13485, based on product use hazard analysis per ISO 14971:2019 and ICH Q9.
FDA Warning Letters and recent recalls indicate major cGMP deficiencies in many companies, particularly in V&V planning and protocol execution. A Master Validation Plan is expected by the FDA under the "c" in cGMP. This course provides the tools to develop meaningful product validations through proper up-front V&V planning and execution.
Sample IQ, OQ, and PQs are illustrated and discussed. The recently updated FDA Guidance on 10 documents for software V&V is presented as a model. All points have been field tested with regulatory agencies in the US, EU, and Asia.
Code: MD2789
Curriculum
Requirements
- Senior and middle management, R&D, Engineering, QA/RA, and Manufacturing personnel
- Applicable to companies in Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields
Meet Your Instructor
John E. Lincoln
FDA Regulatory Affairs, Design Control & QMS Expert
John E. Lincoln has over 40 years experience in U.S. FDA-regulated industries, 30 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new/changed product 510(k)s, process/product/equipment including QMS and software validations, ISO 14971 product risk management files/reports, Design Control/Design History Files, and Technical Files. He has held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). John has prior experience in military, government, electronics, and aerospace industries. He is a peer-reviewed author, teacher, and speaker, and a graduate of UCLA.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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