Test Method / Design Verification and Validation

Speaker

Instructor: John E Lincoln
Product ID: 706920
Training Level: Intermediate to Advanced

Location
  • Duration: 90 Min
Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design Verification and Validation under U.S. FDA cGMP, EU MRD and ISO 14971
RECORDED TRAINING
Last Recorded Date: Aug-2023

 

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

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Description:

Review a company's Test Method and Design Verification and Validation system for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning and associated documentation. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 for hazard analysis and product risk management, allows the development of meaningful product quality-specific process validations, especially at the design stage (820.30). Also the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents. Our matrix examples simplify "as-product", in-product", process and equipment, et al, software VT&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 and cybersecurity are considered where required.

Why Should You Attend:

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in test method / device design verification and validations. What are the regulatory requirements? One major failing is lack of sufficient or targeted risk-based process V&V planning / execution. The "must have" elements from ISO 14971 for hazard analysis and product / process risk management. Integration of test method validation essentials into a company's quality management system, specifically its design control activities.

Areas Covered in the Webinar:

Participants will learn how an effective Test Method Validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety.

Issues to be covered include:

  • Assurance of product quality from CGMP test method compliant validation
  • FDA Test Method V&V requirements
  • Learn methods for developing process validations and best practices
  • Understand the scope of regulations governing test method / design validation and identify gaps
  • Develop a plan to rectify existing validation plans, protocols and reports
  • Learn how to construct, implement and deploy a Validation Master Plan

Who Will Benefit:

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

  • Senior management
  • R&D
  • Quality Assurance / Regulatory Affairs
  • Production
  • Engineering, including Software
  • All personnel involved in verification and/or validation planning, execution and documentation.
Instructor Profile:
John E Lincoln

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 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. 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, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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