CfPIE - The Center for Professional Innovation & Education, Boston, MA USA
October 25 & 26, 2018
Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)
Periodic Product Quality Reviews or Annual Product Reviews of drug products are required by the U.S., EU and Canada. If used effectively, these reviews can be a powerful Quality Assurance tool. The Product Review Process includes: Process Performance and Product Quality Monitoring, Corrective Action/Preventive Action, Change Management and Management Review which are enablers identified in ICH Q10, The Pharmaceutical Quality System. It also includes the ICH Q10 enablers of Knowledge Management and Quality Risk Management. Contemporary guidance suggesting that the Annual Product Review can support the concept of Continued Process Verification and Quality Metrics.
The purpose of the course is to educate the participant in the regulatory requirements for the Annual Product Review while demonstrating the power of the Periodic or Annual Product Review as a Quality Assurance and Quality Improvement tool. We will discuss how the Product Review supports the US, EU and Canadian GMPS while applying the ICH Q10, Pharmaceutical Quality System elements of Process Performance and Product Quality Monitoring, CAPA, Change Management and Management Review, as well as the enablers of Information Management and Risk Management. Discussion will also include the impact of the FDA 2011 Process Validation guidance and the potential impact of the proposed FDA requirement for Quality Metrics on the Product Review.
Topics of discussion include:
- The regulatory requirements for the Annual Product Review
- The Annual Product Review as it relates to other required and expected reports
- The Annual Product Review as part of a contemporary Quality System
- What should be included in the Product Review
- The Product Review as a source of recommendations for process improvement
- Management involvement and responsibility
- The Product Review in support of stage 3 of process validation, continued process verification
- The Product Review process as a user of, and contributor to, the corporate knowledge
- The application of quality metrics to the Product Review process
Participants are encouraged to bring examples of Product Reviews as well as specific questions and concerns that can be discussed during this seminar.
Who Should Attend
This two-day seminar is targeted toward professionals who are responsible for the preparation of the Annual Product Review, or Product Review, or the oversight of the preparation of the Product Review. It also includes information that is pertinent to those who support process validation as defined in the FDA 2011 Process Validation Guidance and those who want to understand the potential impact of the FDA draft guidance on Quality Metrics on Product Reviews and the organization as a whole. This includes professionals in Quality Assurance, Quality Control, Production, Development and other related disciplines.
Jerry Lanese, Ph.D.
Jerry Lanese, Ph.D.
Dr. Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He has managed Analytical Research, Quality Control and Quality Assurance functions in several pharmaceutical firms.
In 1994 Dr. Lanese formed his own company, The Lanese Group, and since that time he has been a consultant in the area of quality systems and cGMP compliance and has consulted with 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 seminars and 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.