Course Description

Annual Product Reviews/Product Quality Reviews

April 24-26, 2023 | Time: 8:30am-1:30pm EDT / 14:30-19:00 CEST
Virtual Course

Course Offering 230424VT1998
Course ID 1998

In-Person Course

Who Should Attend?
This course is targeted toward professionals who are responsible for the preparation of the FDA Annual Product Review, or Product Quality Review, or the oversight of the preparation of the Product Quality Review.

This annual Product Quality Review course also includes information that is pertinent to those who support process validation as defined in the FDA 2011 Process Validation Guidance and those who want to understand the potential impact of the FDA draft guidance on Quality Metrics on Product Reviews and the organization as a whole.

Course Description
Periodic Product Quality Reviews or Annual Product Reviews of drug products are required by the U.S., EU and Canada. The purpose of the annual product quality review course is to educate the participant in the regulatory requirements for the FDA Annual Product Review while demonstrating the power of the Periodic or Annual Product Review as a Quality Assurance and Quality Improvement tool.

We will discuss how the Product Review supports the US, EU and Canadian GMPS while applying the ICH Q10, Pharmaceutical Quality System elements of Process Performance and Product Quality Monitoring, CAPA, Change Management and Management Review. Discussion will also include the impact of the FDA 2011 Process Validation guidance and the potential impact of the proposed FDA requirement for Quality Metrics on the Product Review.

This 12-hour accredited intensive course will discuss the comparative evaluation about similarities and differences of requirements associated with the manufacturing of the drug product in different countries.

Can't Make the LIVE Course dates?
You can register now for the on demand! Simply select the On Demand option when registering and we will automatically send you access to the recorded version for you to view for 30 days. On Demand will be available within 2 weeks after the live offering.

PLEASE NOTE:Since this training is highly interactive, you must have a webcam on your computer equipped with a microphone and speakers/headset in order to fully participate.

Course Director
Danielle DeLucy, Owner/Principal ASA Training & Quality Consulting, LLC

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 20 years serving in numerous Quality Management Roles at Sanofi Pasteur, 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. She has worked with companies such as Johnson & Johnson, Novartis, and Glaxo SmithKline to name a few. Currently, Danielle assists companies who are faced with warning letters, consent decrees, and those wishing to improve compliance to establish more robust quality systems so that the company can succeed.

Venue Information
Online (Live or On Demand)
Attend Online from Your Location
Access Information Sent Upon Confirmed Registration