Indian Rocks Beach, FL 33785
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"Helping People Learn Compliance and Science" SM
Introduction To Laboratory CGMPs:
A Quality Systems Based Approach
Immediately Available for Online Enrollment and Instruction!
ABOUT THE COURSE
"Introduction to Laboratory CGMPs: A Quality Systems Based Approach" is a solid, introductory level and yearly review course based on FDA’s newly adopted quality systems based approach for auditing CGMP facilities. The course materials are based on internal FDA guidance documents and current best practices of the pharmaceutical industry. The course is augmented with real world examples recently encountered by the instructor. This is an excellent means to introduce analytical chemists to laboratory CGMPs and the concepts of current good manufacturing practices in general. It’s also an excellent means for laboratory managers to evaluate how their laboratories measure up to current industry standards. Handouts are all downloadable for future use.
WHO WILL VALUE FROM THIS COURSE
Newly hired analytical chemists preparing to work in a CGMP laboratory environment, QA personnel who review data and audit laboratories, and most laboratory personnel in need of yearly CGMP training, will benefit from this course. Laboratory managers desiring to evaluate the current status of their compliance with CGMPs will also find this course very useful.
COURSE OUTLINE
Module 1: Introduction and Background
Module 2: The Quality Systems Based Approach to Laboratory CGMPs
Module 3: Elements of the Laboratory Control System
- Laboratory Managerial and Administrative Systems
- Laboratory Documentation Practices and Standard Operating Procedures
- Laboratory Equipment Qualification and Calibration
- Laboratory Facilities
- Methods Validation
- Laboratory Computer Systems
- Laboratory Investigations
Module 4: The Law and FDA
Module 5: Review
Module 6: Course Resources
- All Video Clips
- Handouts and Appendices
- Knowledge Check and Certificate Printing
ADMINISTRATION
The course contains approximately six hours of video clips, quizzes, whiteboard discussions, and a final knowledge check which, if you achieve 80% or better you will receive a signed training certificate. It also contains over 200 pages of handouts. Cost is $195 per person, which gives the student complete, unrestricted and open access to the course for a two week period. Purchase is via credit card and is is offered through an e-learning portal referred to as Course City (www.coursecity.com). Enroll now and "Take a Course".
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