Winter/Spring Schedule for Bioscience Industry Training for Professional Development

Published: February 21st, 2018

Category: Education, Event, News

Biotility at the University of Florida CERHB is committed to providing high-quality education and training to facilitate the professional growth of each participant. Our short-courses are attended by professionals, students preparing to enter industry careers, and researchers, all of whom seek to expand and deepen their knowledge in technical and regulatory details unique to biotechnology industries and translational research.

Below are our course offerings for Spring 2018.

Current Good Manufacturing Practices (cGMPs) for the Medical Device Industry

Good manufacturing practices are the regulations enforced by the United States Food and Drug Administration (FDA) for medical devices. They are often referred to as current Good Manufacturing Practices (cGMP’s), and provide the systems and the framework to assure proper design, monitoring, and control of manufacturing processes and facilities. This course will provide an overview of medical device cGMP’s. Attendees will also gain knowledge of what constitutes a medical device, a brief overview of the risk classification of medical devices, management’s role in the implementation of cGMP’s, and the importance of good documentation practices. 

  • Wednesday March 14, 2018 
  • 9 a.m. – 11:30 a.m.
  • Registration fee: $95

Learn more and register >

Medical Device Design Controls

Good manufacturing practices are the regulations enforced by the United States Food and Drug Administration (FDA) for medical devices.  Part of these regulations include controls for medical device design and development.  These specific design and development regulations are termed “Design Controls,” and are referenced in the US Code of Federal Regulations Part 820.30 (CFR 820.30).  They are the application of a formal methodology for design and development of some Class I devices and all Class II and III devices marketed in the United States. Course participants will gain an understanding of these regulations, and how they work to insure that devices meet user needs and intended uses.

  • Wednesday, March 28, 2018
  • 9 a.m. – 11:30 a.m.                                                                      
  • Registration fee:  $95

Learn more and register >

Core Concepts in Biomanufacturing and Quality Systems: Applications of cGMPs

This 2-day 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 process, facilities, quality systems, and documentation to build a solid understanding of the development, manufacture, testing, and release of a regulated product. This certificate short-course will be held at Valencia College’s Lake Nona Campus: 12350 Narcoossee Road, Orlando, FL 32832, Biotechnology Lab, Room 352. 

  • Friday, March 24, 2018 and Saturday, March 25, 2018
  • 9 a.m. – 5 p.m.                                                                       
  • Registration fee:  $250

                                                                                                                                                                              Learn more and register >

Core Concepts in Biomanufacturing and Quality Systems: Applications of cGMPs 

This 2-day 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 process, facilities, quality systems, and documentation to build a solid understanding of the development, manufacture, testing, and release of a regulated product.

  • Thursday, April 5, 2018 and Friday, April 6, 2018
  • 9 a.m. – 5 p.m.                                                                       
  • Registration fee:  $250

                                                                                                                                                                             Learn more and register >

Cleanrooms and Gowning

This course combines lectures on cleanroom operations, design, and procedures, with hands-on experience in an actual cleanroom environment. Participants will gain practical experience learning to gown in and enter an ISO Class 5 cleanroom. 

  • Friday, April 13, 2018
  • 1 p.m. – 5 p.m.                                                                      
  • Registration fee:  $200

Learn more and register >