How much does FDA's 21 CFR Part 11 Add-On Inspections cost?

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

Do I receive a certificate after completing FDA's 21 CFR Part 11 Add-On Inspections?

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

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FDA's 21 CFR Part 11 Add-On Inspections

Navigate FDA's increased scrutiny of electronic records and software validation — implement effective 21 CFR Part 11 V&V strategies aligned with GAMP, ISO 14971, and real-world inspection expectations.

4.8(0 reviews)

1.5 hours

Instructor

John E. Lincoln

FDA Regulatory Affairs, Design Control & QMS Expert

Quantity

Recording – 1 Viewer

$350.00

Buy Now

Secure payment via Stripe

Certificate of completion

What You'll Learn

Current regulatory expectations and recent audit hot buttons for Part 11

The Part 11 Project Validation Plan — structure and essential elements

Simplified approach to 21 CFR Part 11 compliance and software V&V

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

The FDA's 10 Key V&V Documentation Elements

GAMP and IEC 62304 considerations for regulated software validation

About This Event

The verification and validation of cGMP software is coming under increased scrutiny by the U.S. FDA. This webinar addresses the use of U.S. FDA Guidance, GAMP, 21 CFR Part 11, Electronic Records/Signatures, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Risk Management models and their real-world implementation. The FDA has eliminated its "selective enforcement" policy and is now looking for proper implementation of the control of electronic records and electronic signatures. Regulatory auditors are increasingly comfortable delving into software issues. This webinar provides simple but effective real-world 21 CFR Part 11 software V&V strategies in today's resource-constrained environment. Code: FDB2787

Curriculum

Current Regulatory Expectations and Add-On Inspection Hot Buttons

15 min

The Part 11 Project Validation Plan

12 min

Simplified Approach to Part 11 Compliance and Software V&V

12 min

Requirements

Senior and middle management, R&D, Engineering, Software, QA/RA, Manufacturing, and Operations
Applicable to companies in Medical Devices, Diagnostic, Pharmaceutical, 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

21 CFR Part 11 Electronic Records Software Validation GAMP FDA IEC 62304 cGMP

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