How much does IQ, OQ, PQ in the Verification and Validation Process cost?

Registration options: Recording – 1 Viewer: $350; Recording – Unlimited Viewers: $990.

Do I receive a certificate after completing IQ, OQ, PQ in the Verification and Validation Process?

Yes, a certificate of completion is included with your registration.

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Recorded WebinarNew

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.

4.8(0 reviews)

1.5 hours

Instructor

John E. Lincoln

FDA Regulatory Affairs, Design Control & QMS Expert

IQ, OQ, PQ in the Verification and Validation Process

Quantity

Recording – 1 Viewer

$350.00

Buy Now

Secure payment via Stripe

Certificate of completion

What You'll Learn

The Master Validation Plan — structure and FDA expectations

Hardware/equipment and software validation under cGMP

When and how to use DQ, IQ, OQ, PQ, or their equivalents

Product risk management per ISO 14971:2019 and ICH Q9

The FDA's 10 key documents for software validation (recently updated)

Incorporating 21 CFR Part 11 requirements, data integrity, and cybersecurity into V&V

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

The Master Validation Plan — Structure and FDA Expectations

12 min

DQ, IQ, OQ, PQ — When and How to Use Each

15 min

Product Risk Management: ISO 14971:2019 and ICH Q9

12 min

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.

40+ Years FDA Regulated Industries30 Years Independent ConsultantUCLA GraduateDesign Control & Technical File Expert

Quantity

Recording – 1 Viewer

$350.00

Buy Now

Secure payment via Stripe

Certificate of completion

Event Details

Format

Recorded Webinar

Duration

1.5 hours

Certificate

Included

Access

Lifetime

Topics

IQ OQ PQ Validation Master Validation Plan cGMP ISO 14971 ICH Q9 Software Validation Medical Device

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