ComplianceOnline

Process Verification and Validation Planning and Execution

Instructor: John E Lincoln
Product ID: 701662
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jun-2017

Training CD / USB Drive

$299.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.

Why Should You Attend:

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies. And now the FDA is taking an even tougher stance. One major failing is lack of sufficient or targeted risk-based process V&V planning / execution. Pharma companies must consider key elements of the FDA Process Validation Guidance Document; other medical products can use the same principles. Incorporate the "must have" elements from ISO 14971 and ICH Q9 for hazard analysis and product / process risk management. Then integrate all as process validation essentials and incorporate into a company's quality management system.

This webinar will review a company's process verification and validation system for major cGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. Attendees will learn how the FDA's recent process validation guidance for pharma can assist all regulated industries meet regulatory requirements. It will discuss how one can start with a Master Validation Plan, evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management, allows the development of meaningful product quality-specific process validations.

It will also discuss the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources. The speaker will present a matrix that simplifies "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 will also be discussed briefly.

Areas Covered in the Webinar:

  • Verification or Validation -- Recent regulatory expectations
  • FDA's Current Process Validation Guidance
  • Key Process / Equipment V&V Considerations
  • When / How to Use DQ, IQ, OQ, PQ, ASTM E2500 Equivalents
  • Using the Risk Management tools of ISO 14971 and ICH Q9
  • The 11 Elements of the Software VT&V "Model"
  • Avoid recent compliance problems

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to review and modify their Process Validation Planning and Execution / Documentation. While this information is focused on Pharmaceutical and Medical Devices, its principles apply to personnel / companies in the Diagnostic, Combination, and Biologics fields as well. 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
Instructor Profile:
John E Lincoln

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 24 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP.

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Upcoming In-person Seminars by EX-FDA OFFICIALS
Risk Management in Medical Devices Industry

Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied 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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews Write review

From new perspective of FDA's enforcement and Process Validation guidance to Key areas on Validation and Life cycles this seminar provides a very good perspective on how to direct our companies efforts and focus resources.
- Anonymous

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