Biotility online courses coming Oct. 15, in-person courses through Fall 2018

Published: September 24th, 2018

Category: Education, Event, News

Biotility at the University of Florida 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 Fall 2018.

Online courses coming October 15!

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 $75.

  • 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 >


Good Documentation Practices

Numerous types of documents are used in regulated industries, serving functions that include communicating instructions and information, and recording information. Participants in this course will learn the history of GDPs, strategies for implementing compliance, as well as standards and practices for accurately completing cGMP paper records. Requirements of 21 CFR 11, Electronic Records; Electronic Signatures, will also be addressed.

  • Friday, October 19, 2018
  • 9 a.m. – 11:30 a.m.
  • Registration fee: $95

Learn more and register >


Writing Controlled Documents

Current Good Manufacturing Practices (cGMPs) in a regulated industry require the use of controlled documents. Participants in this course will learn strategies for designing and writing controlled documents, with the goal of minimizing risks for misinterpretation, and errors in communication. Participants will also gain an understanding of the associated regulatory requirements and will learn fundamental concepts of document control.

  • Friday, October 19, 2018
  • 12:30 p.m. – 3 p.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.

  • Thursday, November 8, 2018 – Friday, November 9, 2018
  • 9 a.m. – 5 p.m. (both days)                                                                     
  • Registration fee:  $250                                                                                                                                                

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.

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

Learn more and register >