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Date: 3rd - 7th August, 2009
Location: Bethseda, MD, USA
Summary:Pharmaceutical - Training
This five-day workshop offers you a unique opportunity to evaluate several different Rapid Microbiological Systems in a laboratory-based environment. You will hear from two rapid method experts from the US FDA and another from USP. Time will be allotted to 'Ask the Inspector' to get your validation, implementation and regulatory questions answered!
Other lectures will cover important issues regarding rapid microbial systems such as: comparability protocols, validation, acceptance criteria, and hardware and software considerations.
You will also participate in informal discussions with other attendees about the positive and negative attributes of each system related to specific microbiological applications.
Upon completion of this course, participants will be able to:
- Identify various types of rapid microbiological tests that may be routinely performed in a pharmaceutical environment, including validation activities
- Describe at least two key concerns or issues associated with each type of test system
- Relate the regulations and guidelines to the methods associated with rapid microbiology testing
- Manage the pitfalls and difficulties associated with performing the various types of tests on the rapid microbiology systems available
- Recognize the instructions for performing each type of test and what constitutes an appropriate system for their testing
- Create a list of issues and recommendations for these testing methods
Rapid Microbiological Methods Course
