Improve your Quality Reviews - Live Online Training
25/26 June 2026
Course No. 22211
Speakers
Dr. Jens-Uwe Rengers
vorm. Akorn
Dr Rainer Gnibl
GMP Inspector
Cheryl Chia
Lotus Phoenix Consulting
Dr Jean-Denis Mallet
Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
Dr Simone Baisi
KEDRION, SpA
All times mentioned are CEST.
Objectives
This Live Online Training examines regulatory requirements, provides insight into inspectors’ expectations and explains tools for improving your documented review processes.
Based on real examples you will learn how you can implement and improve your Quality Reviews and use them more efficiently.
Background
Quality Reviews and Metrics are critical GMP elements. They are an integral part of a pharmaceutical quality system and provide an opportunity to assess and control relevant processes.
Both parts of the EU-GMP Guidelines require the Product Quality Review (PQR) to verify the consistency and appropriateness of existing processes, but also to identify product and process improvement opportunities.
The FDA 21CFR 211 requires an Annual Product Review (APR) to evaluate annually the quality standards of each drug product.
All relevant guidance do also consider a Management Review to be an appropriate instrument to assess adequacy and effectiveness of quality systems.
All these different reviews could result in a tremendous work load or they can be performed in an efficient way with useful results – depending on how they are organised. Therefore, it is very important to understand the requirements and the idea behind it and to see how these tools can be used more efficiently.
Target Group
This Live Online Training is designed for managers, supervisors and all other staff members in the pharmaceutical and API industry who are involved in preparing and compiling Quality Reviews and Metrics.
Date & Technical Requirements
Date of the Live Online Training Thursday, 25 June 2026, 9.00 – 17.15 h CEST Friday, 26 June 2026, 9.00 – 16.00 h CEST
We use WebEx for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Testimonials
Seminar Programme as PDF