Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Live Webinar
01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar
"Listen From Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems"
Annual Product Quality Review
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.
• Annual Product Review definition
• What needs to be included in the report
• A model of an example Annual Product Review Report
• Review of citations
• 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
• Personnel involved in the preparation of the Product Review
Industries who can attend
This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.