Eliminate the Confusion –Annex 13 GMP guide 2011

  • 17 Feb 2011
  • Webinar

Description

This GMP webinar will help you understand the compliance requirements concerning Annex 13 of the GMP guide.

Areas Covered in the Seminar:


  • Review the role of the "Qualified Person" who must have access to the Product Specification File as the basis for assessment of the suitability for release and certification of a particular batch.
  • Packaging instructions requires expressly with a view to the complicated procedures in the manufacture of investigational medicinal products.
  • The requirement for reconciliation at the end of the packaging and labelling processes.
  • Packaging materials requires special quality control checks for a homogeneous appearance of the packs in order to prevent unintentional unblinding due to a visible difference between the placebo and the active medication packs.
  • Manufacturing operations that the production parameters and the corresponding in-process controls must be deduced from the knowledge actually available at the time.
  • An appropriate process of blinding the test preparation, comparator product and placebo must be completely identifiable.
  • The requirements for the randomisation procedure are also more strictly formulated: in addition, safety aspects and the procedure for breaking the code must be described in the corresponding procedures.
  • The section on the risks of product mix up in the case of simultaneous packaging of different preparations.
  • Labelling is specifically detailed in the draft e.g. name, address and telephone number of the sponsor, contract research organisation or the principal contact for the clinical trial.


Who Will Benefit:


This webinar will provide valuable assistance to all companies/ manufacturing sites. Those that would benefit most would be:

  • Clinical Research Professionals
  • Clinical Research Project Managers
  • Technical Directors / VP`s
  • Operations / Production Managers
  • Quality Assurance Managers
  • SOP mangers and co-ordinators

Past Events

Important

Please, check "Eliminate the Confusion –Annex 13 GMP guide" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical laboratories, Pharma
Science: Laboratories, Life Sciences & Biology
Technology: Biotechnology

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