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.
Below are our course offerings for Fall 2017.
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 in July 2018. 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.
- Wednesday, Nov. 1, 2017
- 8 a.m. – Noon
- Registration fee: $125
HVAC Cleanroom Design Concepts for Pharmaceutical cGMP
Taught by an expert in cleanroom design, this course will cover basic HVAC Cleanroom Concepts involving architectural design, maintenance and validation procedural issues required in a pharmaceutical cGMP environment. Examples of industrial cleanrooms will be highlighted to promote interactive discussion with regards to laboratory design and maintenance of actively used cleanroom environments. Attendees are encouraged to email any specific topics they would like to see addressed.
- Wednesday, Nov. 1, 2017
- 1 p.m. – 5 p.m.
- Registration fee: $125
Core Concepts in Biomanufacturing and Quality Systems: Applications of cGMPs (2-day)
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, Nov. 2 –Â Friday, Nov. 3, 2017
- 9 a.m. – 5 p.m.
- Registration fee: $250
Good Documentation Practices (GDPs) in a cGMP Environment
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.
- Monday, Nov. 6, 2017
- 2:30 p.m. – 5 p.m.
- Registration fee: $95
Writing Controlled Documents in a cGMP Environment
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.
- Tuesday, Nov. 7, 2017
- 9 a.m. – 11:30 a.m.
- Registration fee: $95
Basics of Bioinformatics
This course provides an opportunity to learn and apply the fundamentals of bioinformatics and molecular modeling techniques using the specialized app Molecular World™ and BLAST. We will use these molecular modeling and sequence analysis tools to explore models of small chemicals, proteins, and DNA, and learn how we can use these models to identify cancer-causing mutations, search for drug homologues for various diseases, and understand the function of select anti-viral drugs based on their 3-D models.
- Location: Clinical and Translational Research Building (CTRB)
- Friday, Dec. 8, 2017
- 9 a.m. – 5 p.m.
- Registration fee: $150
Questions?
Tamara Mandell, Director
386.462.6397