In-house Courses
Validation of Microbiological Methods
OUTLINE
This basic course is designed to educate participants in the background of microbiological testing and test validation in the regulatory environment of pharmaceutical support. This course will be extremely important to those new to the industry, or who have recently acquired responsibilities for overseeing a microbiology laboratory function or reviewing microbiological test data. No prior knowledge of pharmaceutical microbiology is needed.
The first day of the course covers basic microbiology in the pharmaceutical setting, general discussions of the validation of those tests, and the regulatory foundation for most microbiological tests. This includes the Antimicrobial Efficacy Test, Microbial Limits Test, Bioburden testing, and the Sterility test. Out of specification and environmental monitoring will also be covered.
The second day of the course covers validation in more detail. Participants will create and critique specific validation procedures, and discuss regulatory guidance to methods validation. A discussion of rapid microbiology methods on the horizon will also be provided.
This is a basic course on validation 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 discussion of currently proposed revisions to these topics, but familiarity with the material will enhance your experience.
If you are interested in a more in-depth treatment of the topic, please consider our advanced course or in a combination of topics from the two in an in-house presentation.
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
- Validation of specific microbiological tests:
- 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
- Discuss the different regulatory assays of importance to the microbiologist, and the portions of those tests critical to validation.
- Develop a validation procedure for major compendial assays such as sterility tests, antimicrobial efficacy tests, and microbial limits water testing
- Evaluate different sampling techniques used in environmental monitoring of air, surface, water, and personnel
- 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
Bring this course to your location
Available Course Offerings
|
