Biotility certificate short courses offered in Spring 2019

Biotility at the University of Florida , part of the CTSI Translational Workforce Development Program, is committed to providing high-quality education and training to facilitate the professional growth of each participant.

These 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 course offerings for Spring 2019.

Online Courses

Developed and taught by an industry expert in the field of medical devices, these content-rich, self-paced courses were created to provide flexible options for busy schedules. The registration fee for these courses is $125.

  • cGMPs for the Medical Device Industry
  • Quality Audits
  • Design Controls for the Medical Device Industry
  • Process Validation
  • Corrective and Preventive Action (CAPA) for the Medical Device Industry
  • Medical Device cGMPs Internationally
  • Regulatory Approval for Medical Devices

Learn more and register >

HVAC Cleanroom Design Concepts for Pharmaceutical Compounding

Taught by an expert in cleanroom design, this course will focus on the revised standards governing pharmaceutical compounding facilities set forth by the United States Pharmacopeia. A new standard focused on hazardous compounding (USP 800) will be introduced on December 1, 2019. The introduction of this new standard will be accompanied by revisions to the existing standards USP 797 and USP 795. We will have an interactive discussion about Common Design/Maintenance Issues which will allow the attendees to discuss their specific challenges. Attendees are encouraged to email any specific topics that they would like to see addressed.

  •  Jan. 11, 2019
  • 1 p.m – 5 p.m.                                                                        
  • Registration fee:  $125                                                                                                                                      

Introduction to Clinical Research

Are you interested in working in the field of clinical research? This course will cover central topics, including personnel roles and responsibilities, study design, data collection, ethical considerations,Good Clinical Practices (GCPs), and regulatory compliance. There will also be discussion on the drug and medical device development processes.

  • Feb. 28, 2019
  • 1 p.m – 5 p.m.                                                                        
  • Registration fee:  $125                                                                                                                                      

Core Concepts in Biomanufacturing and Quality Systems: Applications of cGMPs

This two-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.

  • April 4-5, 2019
  • 9 a.m. – 5 p.m. (both days)                                                                     
  • Registration fee:  $250