Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries"

General procedure for the preparation and documentation of the Annual Product Quality Review

Description

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.

Areas 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

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

Industries who can attend

This 90 minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Danielle DeLucy

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.

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