How to Conduct Annual Product Reviews to Achieve GMP Compliance Annual

Danielle DeLucy

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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.

Why Should You Attend:

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.

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.

Learning Objectives:

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

Areas Covered in the Webinar:

  • 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

Who Will Benefit:

  • Site Quality Operations Managers
  • Quality Assurance personnel
  • Plant Managers and Supervisors
  • Manufacturing Superintendents and Managers
  • Regulatory Affairs Managers
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

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Recorded video

Recorded video session

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Speaker: Danielle DeLucy, Pharmaceuticals, Biotechnology

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 has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.