Annual Product Reviews : New FDA Quality Metrics Guidance on Annual Product Review

Product Id : FDA88
Instructor : Danielle DeLucy
Jan 23, 2018 01:00 PM ET | 12:00 PM CT |10:00 AM PT | 60 Minutes

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Overview

A review, conducted annually to give an organized and comprehensive summary of all production activities, analytical and physical, Stability, Deviations, Change controls, Out of specifications recalls and market complaints, which assess the quality standards of each drug product.

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.

Session Highlights:

  • Annual Product Review definition
  • What needs to be included in the report
  • A model of an example Annual Product Review Report
  • Review of citations
  • 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
  • A brief summery of all batches kept on stability for the product
  • Details of deviation reports/change controls, if any, should be given along with document reference number
  • Details of out of specification results
  • Product complaints received, returned goods, field alert issue and recall if any, along with their investigation reports and corrective action
  • Review of any regulatory changes
  • Details of Licenses status and cGMP certification
  • Completed APR summary and recommendations’s review and approval by HODs Quality & relevant

Who Will Benefit:

  • Quality Assurance Professionals
  • Quality Control Professionals
  • Regulatory affairs
  • Supplier audit groups
  • Director-Quality
  • Directors and Managers of all disciplines
  • Personnel involved in the preparation of the product review
Speaker Profile:

Danielle DeLucy,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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