In-house Courses
Advanced Topics in the Validation
of Microbiological Methods
OUTLINE
This comprehensive two-day course focuses on the practical application of new USP and PDA guidance on validation of microbial recovery and validation of alternate microbiological methods. The course agenda will include a review of current and proposed USP chapters, and specific procedures for validation of your products with those procedures. This intensive course, taught by industry experts, is your opportunity to consider all aspects of microbial validation. By attending this course, you'll obtain valuable information that you can apply immediately.
This is not an introductory course on microbiology methods. If you are new to microbiology in an industrial setting, please become familiar with USP 2004 (or USP 2003) chapters <51>, <62>, <71>, <1111>, <1227> and <1231> before attending. This course will provide some discussion of currently proposed revisions to these topics, but it assumes familiarity with the material and focuses on experimental and statistical validation procedures for the microbiology laboratory.
If you are interested in a more basic course, please consider our validation course, or a customized combination of the two to be offered in-house.
Key Topics
- Overview of USP Chapter "<1227> Validation of Microbial Recovery from Pharmaceutical Articles"
- Overview of validating alternate microbiological methods as described in the proposed USP chapter <1223>, and PDA Technical Report #33
- Statistical Concepts in microbial validation
- Validation of specific microbiological tests:
- Water Testing
- Bioburden Testing
- Microbial Limits Tests
- Sterility Tests
- Antimicrobial Effectiveness Testing
- Methods to demonstrate "equivalence" to compendial methods for quantitative tests, qualitative tests, and identification tests.
Who Should Attend
- Microbiology Laboratory supervisors and Microbiologists responsible for testing and release of Pharmaceutical, Parenteral and Medical Device products.
- Regulatory and Compliance Personnel responsible for auditing of manufacturing facilities and QA and Contract Microbiology Laboratories.
- Professionals who wish to DOCUMENT TRAINING in this new area of microbial testing.
Learning Objectives
At the completion of this course, attendees will be able to:
- Define the USP revision process and the different mechanisms for commentary
- Define the different sources of variability in microbiological tests and determine the appropriate statistical tools to analyze different types of data
- Design a validation procedure for major compendial assays such as sterility tests, antimicrobial efficacy tests, microbial limits and water testing
- Extrapolate from examples provided in the course to develop a proficiency program for technicians in the microbiology laboratory
- Understand the issues surrounding the introduction of alternate technologies in the QA/QC microbiology laboratory, and what technologies are currently available.
Please Note:
It is our intent to make our course a helpful to you as possible. It is offered through the Microbiology Network, and taught by recognized experts in the field. If you have a topic of special interest, or any questions of particular importance to you, please let us know in advance. This will allow the instructors an opportunity to incorporate your concerns into the course. We know how critical your time and money are, and will do everything possible to ensure ensure that you get value from this experience.
Note: This course is being offered in cooperation with the Microbiology Network
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