Speakers
Dr Gerd Jilge
Dr Jilge is working in Quality Management on method
development for new drug substances at Boehringer
Ingelheim Pharma GmbH & Co. KG, Germany. Before
that he held a position in Drug Regulatory Affairs of
Boehringer Ingelheim GmbH with the focus on CMC
documentation for the submission of new and registered drug
products.
Objectives
This webinar gives an introduction of the content of a validation protocol using a chromatographic example for the determination of impurities.
The content of the validation protocol will be discussed with respect to
.. information on specific data for the protocol,
.. detailed information how to carry out the validation experiments,
.. evaluation of data and test results for each validation parameter as well as
.. a proposal for the setting and reporting of the acceptancecriteria.
Furthermore, information on an error handling plan are provided if acceptance criteria cannot be fulfilled, an important topic which is also discussed in the current EMA GMP regulations.
The webinar also considers the validation protocol as an ideal tool for an instruction (SOP) to perform validation experiments.
Background
According the FDA Guideline on „Analytical Procedures and Methods
Validation for Drugs and Biologics“ validation of the analytical
procedures should be carried under an approved validation protocol
or plan which contains all relevant information, e.g. description
of the validation parameters including the responsibilities,
materials used, testing conditions and the respective acceptance
criteria.
Target Group
The webinar targets laboratory managers, supervisors and analysts in pharmaceutical quality control departments who have responsibility for the validation of analytical test procedures. Furthermore, this Webinar is designed for personnel from Quality Assurance,
Regulatory Affairs and Contract Laboratories.
Technical Requirements
To be able to take part in a Webinar, you need a computer with high-speed Internet access (i.e. DSL) and speakers.
Your Internet browser must have following features to use the GMP Webinar system:
1. Adobe Flash-Player must be installed.
2. Javascript must be allowed.
3. Port 1935 must be released.
Please read the detailed technical requirements in this document:
http://www.gmp-compliance.org/webinar/webinar_requirements.htm
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