Pharmaceutical Microbiology

Venue: Holiday Inn Boston-Somerville

Location: Somerville, Mass, Canada

Event Date/Time: Jun 15, 2010 End Date/Time: Jun 16, 2010
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About This Course:
Microbiological contamination of products and processes continues to be a major concern to the industry and its regulators. The potential impact of such contamination can be catastrophic. Put simply, microbial contamination can kill your patients and your business! This course, for non-biologists and microbiologists, is designed to provide you with the knowledge, confidence and decision making risk assessment skills to prevent this happening. You will learn:

Microbiological Best Lab Practices (USP <1117>) – New Draft
Changes in the New Harmonized Microbial Limits Tests: USP <61>, <62>, and <1111>
Characteristics of the Microbes encountered in Pharmaceutical Microbiology
Efficacy of Antimicrobial Preservation
Microbial Identification Techniques
Microbiology Investigations
Validation of Microbial Test Methods
Microbial Identification (NEW USP <1113>)
Detection Methods and Their Limitations
Development of an Effective Disinfectant Efficacy Evaluation Program
Validation of Microbiological Rapid Methods (RMM)
Sterility Test Validation and Critical Parameters
Sterilization and Sterility Assurance
Contract Microbiology Services – Relevant Microbiological Issues
Disinfectant Qualification
The basic characteristics of all microorganisms found in your pharmaceutical environment, how they get there and how you can remove them!
How to sample, isolate, count and identify these microorganisms
Discussion and Working Groups:

A significant proportion of this course will be devoted to group work, where delegates have the opportunity, to put theory into practice. Additionally, discussion periods, provide delegates with an opportunity to obtain answers to their specific questions and concerns.


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