Proper Execution of Annual Product Reviews

An Annual Product Quality Review (APR) is a yearly evaluation that checks whether there have been changes to a pharmaceutical product's specifications or manufacturing process. Its purpose is to reduce product defects and manufacturing risk. This 60-minute annual product review webinar explains how to carry one out properly.

You'll start with the APR definition and what the report needs to include, then work through a model example of an APR report and review related citations.

The session also compares similarities and differences in the requirements for drug product manufacturing across different countries.

• Write an annual product review
• Outline the requirements for APR reporting
• Decide what information to include in the report
• Explain how well-written APRs benefit your firm's compliance

• Annual product review definition
• What needs to be included in the report
• A model example of an annual product review report
• Review of citations
• Similarities and differences in requirements across countries

Regulatory requirements differ from country to country, and understanding them helps ensure product quality. A well-written APR shows that you monitor your product and process and supports your firm's compliance.

The session suits QA and QC, regulatory affairs and compliance, and engineering and development directors, managers and specialists.

Quality Assurance/Quality Control Directors, Managers, and Specialists 

Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists 

Engineering/Development Directors, Managers, and Specialists

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.