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.
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
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
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 …
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