In-house Courses
Pharmaceutical Microbiology for Managers
Outline
Starting from the question of "What is microbiology?" this course provides an introduction to pharmaceutical microbiology for someone who is not familiar with the science of microbiology. Providing a strong regulatory foundation for USP, FDA and EMEA guidelines, this course provides a good introduction to the field with reviews of common tests, manufacturing plant support, audit strategies, and lab practices.
Please note that by the nature of this topic class size must be restricted. Register early to secure a place in this course.
Key Topics
- What is Microbiology?
- Regulatory basis of microbiological testing
- Common tests:
- Antimicrobial Efficacy Test
- Microbial Limits/Bioburden Test
- Sterility Test
- Validation of test procedures
- OOS and Corrective Actions
- Support of Manufacturing
- Water Testing
- Environmental Monitoring
- Media Fills
- Cleaning and Disinfection
- Training Issues
- FDA Issues with Microbiology Labs
- Good Microbiology Lab Practices
Who Should Attend?
- New Microbiology Laboratory supervisors and Microbiologists responsible for testing and release of Pharmaceutical, Parenteral and Medical Device products.
- Regulatory and Compliance Personnel newly responsible for auditing of manufacturing facilities and QA and Contract Microbiology Laboratories.
- Professionals who wish to DOCUMENT TRAINING in this new area of responsibility.
Learning Objectives
At the completion of this course, attendees will be able to:
- Understand the role microbiology plays in product development and product quality
- Know what regulations apply to the pharmaceutical microbiology lab and how to stay abreast of changes
- Understand the need and methods to validate microbial recovery in tests
- Know the current FDA concerns dealing with the Microbiology laboratories
- Investigate microbiological data deviations
- Evaluate methodology used for microbiological and proficiency testing
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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