Dr Rainer Gnibl, GMP Inspector for EMA
Prof Edwin van den Heuvel, University of Technology Eindhoven
Arno Hoekstra, Kite Pharma
Dr Andreas König, Fidelio Healthcare
Dr Jens-Uwe Rengers, JeRo Consulting
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.
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 id
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.
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
This pre-course session will provide you with recommendations, Tools and examples to apply statistical principles in your day-to-day Business and it will help you to meet future challenges.
You will gain understanding of the consequences of appropriate and inappropriate performance parameters and a sound evaluation of data.
The Application of statistical Tools in Data Review
- Ongoing/data collection and management
- Interpretation, comparison and presentation of data
- Describing process capability and Performance
- Control Charts; what is a trend and how to deal with it?
- Quality Metrics
- Documenting the outcomes; are we in control?
- Quality Review Summary Report
- Descriptive statistics
- Outlier detection
- Normality testing
- Quality Review Performance
- Control Charts
- Capability indices
- Case study on analysing and interpreting process Performance data.
Recording from 24.03.2021
Duration of recording: approx. 5 hours