Modern Microbiology Laboratory Pharmacopoeial and GMP Compliance
: 17 Sep 2019 - 19 Sep 2019
: Munich, Germany
Type: Training, Workshop
Most tests applied in microbiological QC are described in detail in the different Pharmacopoeias (e.g. EP, USP, and JP). These methods are regarded as being validated – but not for your products! In the end, it is up to you to prove that the official methods function in your Environment.
The validation of microbiological test methods, for your needs, consumes a lot of time, money and manpower. Things can get more complicated if your products interfere with the execution of the test. The real challenge is to fulfil both, regulatory requirements and at the same time financial targets set by your Management.
During this 3-day workshop you will develop strategies for a sustainable approach to performing microbiological test procedures in compliance with the regulations. This course will give you clear guidance on how to cope with these tasks besides your routine laboratory work.
The key tool of this seminar will be team work. During interactive sessions you will create procedures for the most common microbial test methods. Our experienced ECA course leaders will moderate the discussions to lead you to practice-oriented solutions. After completion of the course you will be able to run microbiological test procedures in a compliant and at the same time efficient manner. To guarantee optimal conditions for the exchange of opinions and experiences, the number of participants is limited!
This course will provide practical guidance on implementing the harmonized test methods as well as alternative microbiological methods.