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.
WHY SHOULD YOU ATTEND?
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.
AREA COVERED
- 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
LEARNING OBJECTIVES
- 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
WHO WILL BENEFIT?
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.
- 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
- 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
Quality Assurance/Quality Control Directors, Managers, and Specialists
Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
Engineering/Development Directors, Managers, and Specialists