How to Conduct Annual Product Reviews to Achieve GMP Compliance
Learn how to write compliant Annual Product Quality Reviews (APRs) — covering regulatory requirements, what to include, and how well-written APRs strengthen your compliance position.
Instructor
Danielle DeLucy
Pharmaceutical Quality & Microbiology Consultant
What You'll Learn
About the event
About this event
Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product, any change in the specifications, or any change in the manufacturing process. It is designed to minimize product defects and the risks associated with manufacturing.
This webinar provides a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review, focuses on regulations and regulatory requirements per US and European standards, and discusses how well-written APRs benefit your firm's compliance.
Code: FDB3164
Curriculum
Requirements
- Quality Assurance, Compliance, and Regulatory Affairs teams in pharmaceutical manufacturing
- Applicable to any professional responsible for annual product review preparation or approval
Meet Your Instructor
Danielle DeLucy
Pharmaceutical Quality & Microbiology Consultant
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 clients. In the years after, she held positions in quality management while increasing her responsibility. She has helped lead many Regulatory Health Inspections and was instrumental in coaching peers prior to inspections. Currently, Danielle assists companies faced with warning letters, consent decrees and those wishing to improve compliance and establish more robust quality systems.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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