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 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). 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.
- 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 -Canada –GMP Guidelines ;1.5 - Canada- GMP; GUI-0001 ; C.02.011
- ICH Q10 ; Pharmaceutical Quality System
- The impact of the New FDA Quality Metrics program
Who will Benefit
The following individuals or disciplines will benefit from attending this Webinar:
- Senior Management
- Production Management
- Quality Management
- Quality Assurance
- Quality Assurance Product Reviewers
- Personnel involved in the preparation of the Product Review
Industries who can attend
This 120-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Faculty John G. Lanese
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.