How to Conduct Annual Product Reviews to Achieve GMP Compliance
75 Minutes
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 or any change in the specifications of the product or any change in the manufacturing process. It is designed to minimize the product defects and also the risks associated with the manufacturing of the pharmaceutical product.
WHY SHOULD YOU ATTEND?
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe. It will also discuss the comparative evaluation about similarities and differences of requirements associated with the manufacturing of the drug product in different countries. It is also necessary to know that the regulatory requirements of different countries are different and hence this will further guarantee the quality of the pharmaceutical product.
AREA COVERED
- Annual Product Review definition
- What details needs to be included in the report?
- A model of an example Annual Product Review Report
- Review of Citations
LEARNING OBJECTIVES
- Discuss how to write APRs
- Outline the requirements for APR Reporting
- Review what information needs to be included in the reports
- Discuss how well written APRs benefit your firm’s compliance
WHO WILL BENEFIT?
- Quality Assurance Teams
- Compliance Teams
- Regulatory Affairs Teams
- Quality Assurance/
- Quality Control Directors,
- Managers, and Specialists
- Regulatory Compliance Directors
- Engineering/Development Directors
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe. It will also discuss the comparative evaluation about similarities and differences of requirements associated with the manufacturing of the drug product in different countries. It is also necessary to know that the regulatory requirements of different countries are different and hence this will further guarantee the quality of the pharmaceutical product.
- Annual Product Review definition
- What details needs to be included in the report?
- A model of an example Annual Product Review Report
- Review of Citations
- Discuss how to write APRs
- Outline the requirements for APR Reporting
- Review what information needs to be included in the reports
- Discuss how well written APRs benefit your firm’s compliance
- Quality Assurance Teams
- Compliance Teams
- Regulatory Affairs Teams
- Quality Assurance/
- Quality Control Directors,
- Managers, and Specialists
- Regulatory Compliance Directors
- Engineering/Development Directors
Speaker Profile
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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