Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements and the Impact of the New FDA Quality Metrics Guidance on Annual Product Reviews

Live, Interactive Training Webinar

Date: Wednesday December 12, 2018
Time: 9:30am - 11:30am ET (New York Time)
Instructor: Jerry Lanese Ph.D. Biography>>>

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Product Reviews are often requested by regulatory investigators. Annual Product Reviews have been a requirement of the US GMPs for pharmaceutical products since 1978. Since the turn of the century EU and Canada have included a requirement for Annual Product Quality Reviews in their regulations or guidances covering drug products. Inadequate Annual Product Reviews has been the subject of US FDA 483 observations and Warning Letters. The concept of ongoing product, process and system reviews is a vital part of the philosophy of continuous improvement found in the Pharmaceutical Quality System outlined in ICH Q10 and the FDA Guidance to the Industry: “Quality Systems Approach to Pharmaceutical GMP Regulations”. Metrics that relate to the Product Review will be part of the FDA Quality Metrics Program and increase the importance of the Product Review. Product Reviews are a vital component of an effective Quality System and will increase in importance in the coming years.

In this live training webinar we will discuss the world-wide regulatory requirements for Annual Product Reviews (or Product Quality Reviews). The new focus on management involvement in the Product Review process, driven by the FDA Quality Metrics program will be discussed. Different geographic requirements for product review content will be discussed and evaluated. These requirements will also be related to the evolution of regulations and Quality Systems. Systems for the preparation of the product review will be discussed. Finally, we will discuss the expectation for product, process, and quality system review to support the evolving regulatory expectation for continuous improvement within a contemporary Pharmaceutical Quality System.

Learning Benefits:
-Requirements for Annual Product Reviews (Product Quality Reviews).
-Annual Product Reviews and Annual Reports.
- The Product Review as a tool in Stage 3 of Process Validation – Continued process verification.
-What should be included in the Annual Product Review.
-Annual Product Review preparation.
-Continuous improvement and the product review.
-Management involvement.in the Product Review process
-Learn about the regulations governing product review including:
-US 21CFR211.180(e)
-EU GMP Guide; 1.5 -EU GMP Guide; 1.5 -Canada –GMP Guidelines; GUI-0001; C.02.011
-ICH Q10; Pharmaceutical Quality System
-The impact of the New FDA Quality Metrics program

Webinar outline and time breakdown:

Time*
09:15 AM Log In Period
09:30 AM Introduction
09:40 AM Terminology: Annual Product Review, Product Quality Review, Annual Product Quality Review,
Requirements for the Annual Product Review,
What should be included in the product review,
10:30 AM Break
10:40 AM The trend in requirements for Annual Product Review,
Evolution of the Quality System, Impact of Quality Metrics,
Annual Product Review Preparation,
Annual Product Review and Management,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A Copy of the presentation slides
  • Table – Comparison of Product Review Requirements
  • A copy of the FDA Quality Metrics Guidance
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Senior management
  • Production management
  • Quality management
  • Quality Assurance
  • Quality Assurance Product Reviewers
  • Regulatory
  • Personnel involved in the preparation of the Product Review

Registration Form ►


Instructor: John G. (Jerry) Lanese Ph.D.

John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan. Since leaving graduate school, Dr. Lanese has had post doctoral research appointments, taught at the college level, filled several Quality Unit positions in the pharmaceutical industry and for the past 15 years he has been an independent consultant, with a focus on the FDA regulated industries. As part of his consulting practice Jerry lectures throughout the world on a variety of topics related to Quality Systems. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology. In 2005, his article “Training and the Laboratories” was selected as best article of year by the Journal of GXP Compliance. Recently, in 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry… Full Bio>>>

 

 

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