How to Conduct an Effective Annual Product Quality Review

Duration: 60 Minutes
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 Quality Review
Instructor: Danielle DeLucy
Product ID: 501733
Objectives of the Presentation
  • 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
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. If done properly, the Annual Product Review (APR) report can be a highly valued administrative tool by upper management.

Areas Covered
  • Annual Product Review definitions
  • Key benefits or purposes for effective APRs
  • What needs to be included in the report
  • Records and data
  • Approaches for completing APRs
  • Decision making based on APRs
  • Regulatory expectations for Annual Product Reviews
  • A model of an example Annual Product Review Report
  • Review of citations
Who will Benefit
This course is designed for professionals in the Pharmaceutical, Biotechnology and related industries who design, manufacture, organize or otherwise manage drug products and/or active pharmaceutical ingredients (API). It will be especially beneficial to individuals in the following areas:
  • QA staff and management
  • Compliance Personnel
  • Regulatory Affairs
  • Quality Assurance
  • Product Submission
  • Training
  • Consultants
  • Clinical Research
  • Documentation and Technical Writing
  • Project Management
  • Product Development
Topic Background
Annual Product Review (APR) is a critical cGMP requirement. It is an integral part of QA function, which provides an opportunity to assess the state-of-control of the product and process. Annual Product Reviews not only are required by GMP but also can be a robust quality improvement tool if utilized properly.

A 2015 FDA guidance on Quality Metrics places additional emphasis on the Annual Product Review. The FDA will be focusing more on the content of the Annual Product Review and the involvement of senior management in the review and follow-up of the Annual Product Review.
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  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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.
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