Online Webinar 2019 - Live Webinar Annual Product Quality Reviews ; Preparation & Reports - 2015 FDA, EU & Canada Regulatory Requirements

Overview
Product reviews are often requested by regulatory investigators. Annual Product Reviews have been a requirement of the US GMPs for pharmaceutical products since 1978. More recently 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". More recently, the product review has been referenced as a mechanism for verifying that a process continues in a validated state in the FDA Process Validation Guidance. Product Reviews are a vital component of an effective Quality System.
Objectives of the presentation are to talk about:
Requirements for Annual Product Reviews (Product Quality Reviews).
Annual Product Reviews and Annual Reports.
The Annual Product Review as a tool for the verification that a consistent, repeatable process occurs in the actual production environment.
What should be included in the Annual Product Review.
Annual Product Review preparation.
Continuous improvement and the product review.
Management involvement.
Regulations governing product review including:
US 21CFR211.180(e)
EU GMP Guide ; 1.5 -Canada –GMP Guidelines ; GUI-0001 ; C.02.011
ICH Q10 ; Pharmaceutical Quality System
US FDA Guidance to the Industry ; Quality System Approach to Pharmaceutical GMP Regulations
Why Should you Attend
In this live training webinar we will discuss the world-wide regulatory requirements for Annual product Reviews (or Product Quality Reviews). 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.
Who can Benefit:
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
Instructor Profile
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 and began his career teaching Analytical Chemistry in a small liberal arts college. Dr.Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.
In 1994 Dr. Lanese formed his own company, The Lanese Group, since then he has been a consultant in the area of quality system and cGMP compliance and has been consulted by small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations.
Dr. Lanese lectures throughout the world and presents webinars on a variety of topics related to Quality Systems, GMPs, APIs, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. 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 the best article of the year by the Journal of GXP Compliance. In 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry. Jerry is a member of the Editorial Board of the Journal of GXP Compliance.