In-house Courses
Microbiology Issues in Pharmaceutical Manufacturing:
Environmental Monitoring and Cleaning/Disinfecting
OUTLINE
The FDA's recent draft of the "Guide to Aseptic Processing" repeatedly urges a comprehensive knowledge of the microbial population present in all classes of clean rooms at your facility. Contamination prevention in your manufacturing facility begins with the choice, qualification, and proper application of disinfectants during cleaning. Cleaning and disinfecting a manufacturing suite is a science, not an exercise.
Understanding disinfectant qualification methods and the translation of this qualification to cleaning procedures is the key to avoiding contamination and its pitfalls such as failed media fills or sterility tests. Use your EM trending data to develop effective disinfectant efficacy studies and implement robust cleaning procedures to prevent contamination in your manufacturing facility to ensure your product’s integrity.
Key Topics
- FDA Guidance relevant to microbiology in support of pharmaceutical manufacturing
- Developing an Environmental Monitoring Master Plan
- Tracking and Trending of Envrionmental Monitoring Data
- The use of FDA 483 observations to avoid problems in your facility
- Theory and practice of disinfectants
- Development of a Cleaning/Disinfection Plan
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.
- Manufacturing personnel responsible for the plant environment who wish to DOCUMENT TRAINING in this area.
Learning Objectives
At the completion of this course, attendees will be able to:
- Understand the basics of an Environmental Monitoring plan and how to apply it to control of contamination.
- Develop a trending analysis for your facility.
- Evaluate methodology used for microbiological and proficiency testing.
- Evaluate and select appropriate disinfectants for your application.
- Review existent 483 observations to avoid pitfalls in your facility.
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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