Webinar: Method Transfer - New EU and WHO Requirements and Practical Implementation

Method Transfer - New EU and WHO Requirements and Practical Implementation

recorded on 16 December 2014


Costs

Non-ECA Members: EUR 199,--
ECA Members: EUR 149,--

(All prices excl. VAT)

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

Background
Transfer of analytical methods is always an issue, especially during GMP inspections. Method transfers are an important part of pharmaceutical development. Compliance with international guidelines as well as cooperation between the transferring and the receiving laboratory are crucial.

This webinar was designed in order to show practical aspects of method transfer in compliance with current regulatory guidelines, especially the new EU GMP Chapter 6 and the detailed requirements of WHO Guideline Annex 7.

Educational Objectives
This webinar aims at giving you a comprehensive but still compact overview about the transfer of analytical methods.

Current Guidelines:
WHO Guideline Annex 7
New EU GMP Guide Chapter 6
USP <1224>

Practical aspects:
When does method transfer take place?
Which guidelines to follow?
How does method transfer take place?
Transfer protocol and transfer report
Practical examples

Target Audience
The webinar targets executives and staff in quality control laboratories, who want to get a compact but yet comprehensive overview of the transfer of analytical methods.

Speaker
Dr. Ralph Nussbaum
Ralph Nussbaum was head of an F&E analytical laboratory at Grunenthal GmbH in Aachen, before he joined Carbogen Laboratories as head of quality control in Hunzenschwil, Switzerland. In 2002 he took over responsibility for quality assurance as qualified person for drug substances at Carbogen. Since 2003 he is heading Analytical Services in Aachen.

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK