Proper Execution of Annual Product Reviews

Recorded Session
60 Minutes

OVERVIEW

    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.

Learning Objectives

    • Discuss how to write APRs
    • Outline the requirements for APR reporting
    • Review what information to include in the reports
    • Discuss how well written APRs benefit your firm’s compliance

Why Should You Attend?

    This webinar will 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

    This webinar will review:

    • Annual Product Review definition
    • What needs to be included in the report
    • A model of an example Annual Product Review Report
    • Review of citations

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

Webinar Option
Transcript
Downloadable Recorded Session
Training CD

Speaker Profile

ins_img 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 …