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.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
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.