Certificate short courses for those seeking a career in the bioscience industry
These certificate short courses for those seeking a career in the bioscience industry are based at Biotility, at the University of Florida Center of Excellence for Regenerative Health Biotechnology in Alachua, affiliated with the CTSI Translational Workforce Development Program.
- Elements of a GMP-Compliant Quality Control Lab
Thursday, Jan. 12, 2017, 1 p.m. to 5 p.m.
The quality control (QC) unit serves an important role in the (bio)pharmaceutical industry by assessing and measuring specific and pre-defined parameters to ensure the safety and quality of (bio)pharmaceutical products. Erroneous QC laboratory analyses may have dire consequences for consumer health if out-of-specification product is sold. Topics discussed in this course include an overview of regulatory requirements, QC laboratory activities including raw materials, in-process and finished product testing, and handling out-of-specification (OOS) test results. Equipment qualification, method validation, and vendor qualification will also be covered. Practical examples, case studies and hands-on activities will be used to illustrate FDA QC laboratory hot button issues and regulatory compliance as related to the GMP-compliant QC laboratory.
- Principles of Current Good Manufacturing Practices (cGMPs)
Thursday, Feb. 16, 10 a.m. to noon
This is a two-hour lecture-based course covering cGMP’s, regulatory compliance, and maintaining a culture of quality. Participants learn the core precepts of the FDA’s current Good Manufacturing Practices and their direct application to the manufacture and testing of a regulated product. Perfect for fulfilling the FDA’s cGMP training requirement.
- Quality Audits in the (Bio)Pharmaceutical and Device Industry
Friday, March 3, 10 a.m. to noon
External and Internal Quality Audits in GMP manufacturing including the (bio)pharmaceutical and medical device industries are global regulatory compliance tools to ensure the safety and effectiveness of drugs, vaccines, other biological products, and devices. The course includes an overview of regulatory requirements, the different types of audits, and how to prepare for, conduct, and follow up on an audit. Special attention will be given to the internal audit which is a company’s most important managerial tool for monitoring the quality of processes and products. Internal audits, when effectively implemented, are critical to the identification of weaknesses and the continual improvement of the Quality System.
- Core Concepts in Biomanufacturing and Quality Systems: Applications of cGMPs
April, 6-7, 2017, 9 a.m. to 5 p.m.
Created in response to industry demand for employees who understand the practices and nuances of working in a regulated industry, this course provides future or current employees a comprehensive and applied understanding of how regulatory compliance is built into all aspects of a company. Using a blend of hands-on applications and lectures, course instructors integrate current Good Manufacturing Practices with core concepts of the manufacturing processes, facilities, quality systems, and documentation to build a solid understanding of the development, manufacture, testing, and release-for-sale of a regulated product.