Course No 16317
|Non-ECA Members:||EUR 1790,--|
|ECA Members:||EUR 1590,--|
|EU GMP Inspectorates:||EUR 895,--|
|APIC Members:||EUR 1690,--|
(All prices excl. VAT)
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During this workshop, the following contents and questions should be addressed by presentations and panel discussions. Considering that, panelists from the fields Non-Sterile Products, Sterile Products, Combination Products as well as biopharmaceutical APIs will be on hand for the workshop.
In their Pharmacopeial Forum 39(4) in 2014, the USP published the draft of chapter <1115> “Bioburden Control of Nonsterile Drug Substances and Products”. The document outlines a risk-based approach to the control of potential contamination in non-sterile product manufacturing.
But “bioburden” is not only a topic of Non-Sterile Products. Annex 1 of the European GMP Guideline requires “The bioburden should be monitored before sterilisation. There should be working limits on contamination immediately before sterilisation, which are related to the efficiency of the method to be used. Bioburden assay should be performed on each batch for both aseptically filled product and terminally sterilised products.”
And last but not least, bioburden testing for medical devices made or used in the USA is governed by Title 21 of the Code of Federal Regulations and worldwide by ISO 11737.
The current developments determine us to address this topic in a special workshop session to look at this from various angles and provide you with information about the regulatory background and practical examples and strategies for bioburden control. Pharmacopoeial experts, representatives of pharmaceutical quality control and from testing laboratory will show you what the challenges of the bioburden control strategy are and how they implemented an adequate control in their companies.
This conference is of interest to professionals in microbiology from
Pharmaceuticals and Biopharmaceutical Companies
Academic Research Institutions
Contract Service Laboratories
who are involved in
Research and Development
Microbiological QA and QC
Topic: General Information
Bioburden control strategy dependent of the lifecycle phase of the product (so-called “Phase-appropriate control strategy”)