Webinar: EMA´s Q & A regarding PDE-values

Webinar: EMA´s Q & A regarding PDE-values

Heidelberg, Germany

Course No 17653


Costs

Non ECA Member: EUR 249,--
ECA-Member: EUR 199,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Robert Schwarz, FH Campus, Vienna, Austria

Background

Preventing cross contamination is an essential GMP-requirement and has already been mentioned in the EU GMP Guideline since its first publication in 1989. However, in the last years this requirement has become more and more relevant. There is a stronger focus on cross contamination since the EMA has published their „shared and dedicated facility guideline“ regarding the use of multi-purpose equipment. In this guideline, health-based exposure limits (HBEL) and permitted daily exposure-values (PDE) are implemented as state of the art values. Consequently, the chapter 5 of the EU GMP Guideline and the Annex 15 have been revised in the same direction. A Question and Answers (Q&A) draft document and now the final version should interpret EMA´s „shared and dedicated facility guideline“. De facto, these two Q&A´s have led to some confusion in the pharmaceutical industry.

Target Group

We address staff from the pharmaceutical industry and API manufacturers who are interested in the topics cross contamination and cleaning validation, e.g. head of production, validation managers, QA-personnel etc.

Technical Requirements

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.

Programme

  • What is a Q&A document?
  • The PDE concept – how was it developed?
  • Why the use of HBEL/PDE values?
  • How to get HBEL/PDE values?
  • EMA´s Q &A document for the interpretation of EMA´s 
  • “Shared and Dedicated Facilities” guideline
  • Comparison of the Q &A draft (2016) and the final version (2018) – What changes?
  • Influence of the Q & A document on cleaning validation

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