Online Seminar 2019 - 90 Minutes Webinar Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada

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.
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
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
Key Learning Objectives of your Topic:
• 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
The following individuals or disciplines will benefit from attending this Webinar:
Senior management
Production management
Quality management
Quality Assurance
Quality Assurance Product Reviewers
Regulatory
Personnel involved in the preparation of the Product Review
Faculty
Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy 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.
Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, 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 lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.