The Biotechnology Career Interest Team is supported by the Biotility program at the UF Center of Excellence in Regenerative Health Biotechnology (CERHB). Biotility is a state resource for biotechnology and medical device industries, and for individuals seeking to transition into industry careers. Biotility provides high-quality short-courses for 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. UF graduate courses that are especially relevant to biotechnology careers will be included in the career course listing.
Contact: Tamara Mandell, MEd, CERHB Assistant Director for Education and Training (email@example.com)
Biotility has moved to a new testing and training facility! Come visit us in Foundation Park, 14193 NW 119th Terrace, Alachua, FL 32615
Biotility Certificate Short Courses
Register for upcoming courses at: http://biotility.research.ufl.edu/all-courses/#industryTraining
Core Concepts of Biomanufacturing and Quality Systems
May 11-12, 9:00 am – 5:00 pm
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.
May 12, 2020 4:00 pm – 5:00 pm
Speaker, Mr. Brad Fackler, NIH OITE Industry Advisor
We will discuss the landscape of the biotech industry in Maryland with a focus on what companies are located here, how do you find them, and how do you position yourself for a job in these companies.
Corrective Action Preventive Action
May 13, 9:00-11:00 am
CAPA… the word strikes fear in the hearts of some, dread in the hearts of others. But the truth is that CAPAs are here to help you. CAPAs are an essential part of any biotech quality management system, are required by law, and are good for business when done right. This course will provide an overview of CAPA principles, along with some best practices and examples of how things can go wrong.
May 13, 9:00-11:00 am
Inventory is expensive and difficult to manage, and yet is an essential requirement for providing great service to customers. This course provides the tools to retain enough inventory to assure high levels of customer service, while avoiding excessive inventory levels that can create losses.
Topics in this course cover a mix of classic and advanced management techniques to keep firm control over the mix and amount of inventory. Any business with an inventory must ensure they never order too many or too few materials, and that they never place an order too early or too late. Making these inventory management mistakes can result in running out of products, or overspending on holding and ordering costs, both of which are bad for business. This course will show you the best inventory models available, to ensure your goods and services flow to your customers without delay.
FDA Guide to Warning Letters
May 13, 1:00-3:00 pm
The outcome of regulatory inspections is critical to an organization’s success. If the outcome of the inspection results in FDA 483 observations or a warning letter, it is important to take the observations and subsequent responses very seriously. This course discusses the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters, as well as providing essential elements of a thorough response. Additionally, this course reviews the proper structure of the response to ensure that the regulatory agency’s expectations are met and the submission process is properly understood.
Cleanrooms and Gowning
May 14, 8:30 am – 12:00 pm
This course combines lectures on cleanroom operations, design, and procedures, with hands-on experience with aseptic technique and gowning practices in an actual cleanroom environment. The Cleanrooms and Gowning course offers an excellent opportunity for current or future industry professionals to gain practical experience within this critical aspect of Current Good Manufacturing Practices.
Architectural Considerations for Cleanrooms
May 14, 1:30-5:00 pm
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.
Biotility Online Courses
Developed and taught by industry experts, these content-rich, self-paced courses were created to provide flexible options for busy schedules. Click on the titles below for full descriptions.
- 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
REGISTRATION FEE: $125 Register Here