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*

10:15 AM Log-In Period

10:30 AM Introduction

                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,

11:30 AM 10 Minute Break

                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,

12:30 PMLive 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 training for attendee training records

Who should attend:

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

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

How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.