In-house Courses
Auditing the Microbiological Laboratory
OUTLINE
Providing a strong regulatory foundation for USP, FDA and EMEA guidelines. This comprehensive training course demonstrates best practices for auditing QC microbiological laboratories.
This course begins by reviewing current updates to FDA requirements and recent enforcement trends in regulated environments. Additional strategies demonstrate how to identify the most relevant technical aspects for quality control laboratories and evaluate the equipment and media used in the lab.
Explore the latest FDA compliance trends in microbiological test methodology and better assess compendial and proficiency tests, including those done during pre-approval inspections.
Learn to qualify environmental parameters and evaluate best handling practices, proper gowning methods, and compliant storage processes. Further focus for examining retest results emphasizes the logic and rationale for conducting the tests and how the results were achieved.
After completing the course, you will be able to assess effective data gathering techniques, evaluate automated microbial systems and ultimately reveal best practices for auditing compliance. In addition, FMEA and risk analysis approaches to problem solving are introduced.
Key Topics
- QC in the microbiology laboratory
- FDA Guidance on auditing the microbiology laboratory
- Regulatory basis of microbiological testing
- Validation of test procedures
- Documentation and Data Storage
- OOS and Corrective Actions
- FMEA
- Health and Safety Audits
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:
- Ensure compliance with cGMP for the Microbiology lab
- Investigate microbiological OOS results
- Evaluate methodology used for microbiological and proficiency testing
- Comply with documentation standards
- Evaluate new, rapid microbiological methods for suitability of purpose
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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