Improve your Quality Reviews - Live Online Training
29/30 March 2023
Course No. 20193
Speakers
Dr. Jens-Uwe Rengers
vorm. Akorn
Dr. Rainer Gnibl
GMP Inspektor, Regierung von Oberbayern
Cheryl Chia
Lotus Phoenix Consulting
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.
Technical Requirements
We use WebEx Events for our live online training courses and webinars. At https://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.
Quality Reviews in the Context of FDA, EU and ICH Requirements and Expectations
EU-GMP: which types of Quality Reviews are required?
EU Quality System Review (overview)
How to achieve EU-GMP compliance
ICH/US-FDA view on the situation (overview)
EU Product Quality Review (PQR) - Technical terms and aims of PQR - What documents and data should be reviewed? - Are EU-requirements the same for APIs & medicinal products? - What about US-FDA and ICH?
PQR and APR
How to combine PQR and APR in an efficient way
Well-proven PQR/APR designs
Interface to Regulatory Affairs
Certainties (PQR/APR in Custom Manufacturing, how to deal with limited numbers of batches …)
EU Product Quality Reviews in the Light of Inspections – Expectations of the Agencies
Inspectors view on critical parts of EU-PQR
Practical implementation and inspection
PQR and contract manufacturing
Comparison EU-PQR and US-APQR (inspectors point of view)
Discussion of given PQR-Examples Based on real examples, the speaker will discuss the content and lay-out of PQRs:
What is useful?
What is ambiguous?
What could be improved?
Set up of efficient PQRs and APRs
How to profit from existing QA Systems in PQR/APR and vice versa
Best practices
Time/efforts needed
Ongoing data collection
Foreseeable complications/advantages
Well-proven examples
Management Review
Definition, scope, objectives
Organisation
Participants, responsibilities
Topics to be presented: input and output
KPIs per system
Examples and experience
Using KPI in Quality Reviews and in Communication with Authorities
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
Testimonials
Seminar Programme as PDF