Biotechnology

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 (tmandell@cerhb.ufl.edu)

Biotility has moved to a new testing and training facility!  Come visit us in Foundation Park, 14193 NW 119th Terrace, Alachua, FL 32615

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Core Concepts in Biomanufacturing and Quality Systems: Applications of cGMPs

November 13-14, 2019, 9:00 am – 5:00 pm

COURSE DESCRIPTION

Created in response to industry demand for employees who understand the practices and nuances of working in a regulated industry, this 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 processes, facilities, quality systems, and documentation to build a solid understanding of the development, manufacture, testing, and release-for-sale of a regulated product.

LEARNING OUTCOMES

• Identify primary aspects of regulatory compliance with respect to departmental roles and responsibilities
• Gain a working knowledge of cGMPs and the relationship between compliance and risk management
• Apply cGMPs to the manufacture, testing, and release for sale of a regulated product
• Demonstrate the use of industry-specific documentation to meet cGMP requirements
• Understand the correlation of facility, equipment, and process control via qualification and validation

COST:  $250*     MORE INFO AND REGISTRATION

*25% discount for students and postdocs ($187.50)

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Cleanrooms and Gowning

November 15, 2019, 8:00 am – 12:30 pm

COURSE DESCRIPTION

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 cGMPs.

LEARNING OUTCOMES

• Reference the International Organization for Standardization (ISO), its purpose, and cleanroom classifications
• Understand the purpose and influence of standards and regulations in clean manufacturing
• Discuss strategies for cleanroom design, operations, and behaviors to best achieve and maintain classification specifications
• Demonstrate successful gowning and aseptic processing in a Class 5 cleanroom

COST:  $200*     MORE INFO AND REGISTRATION

*25% discount for students and postdocs ($150.00)

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NEW! The 5 Pillar Strategy for a Lean Workplace

November 15, 2019, 1:00 – 5:00 pm

COURSE DESCRIPTION

The 5 Pillars course covers the core principles of 5S, and illustrates why using 5S is essential to your “Lean” initiative. 5S is one of the most versatile Lean techniques, and can be used in almost any work environment, whether it is a busy professional office, an auto shop, healthcare facility, laboratory, school, or the factory floor. The 5S program can have an insightful impact on your company’s organization and production.

This course examines the positive environmental impacts of 5S, and how to make immediate improvements with real long-term benefits. It also explains the importance and structure of 5S Teams; who should be involved, who benefits most and how to get the biggest results from your 5S effort.

LEARNING OUTCOMES

At the end of this course participants will be able to understand the concept of the 5S, select appropriate 5S techniques, and apply a systematic problem-solving methodology and improve the quality and productivity of products and service of the company. Participants will learn this simple, effective and orderly technique to identify and remove waste from your work environment.  Participants will have the knowledge and ability to, initiate the 5S strategy, eliminate non-value-added steps and reap the benefits of 5S.

• Participants will be able to create a unified communications and collaboration system to help improve their business in a variety of ways through 5S implementation.
• All employees, as well as customers, vendors and contractors, can work together in a much more standardized efficient way.
• Improved safety, less errors and lower costs of operations.
• Improved quality, increased productivity and higher employee satisfaction.

COST:  $150*     MORE INFO AND REGISTRATION

*25% discount for students and postdocs ($112.50)

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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

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BIOSTATISTICS 101 for Cancer Researchers
The University of Florida Health Cancer Center
Fall 2019  (August 29-October 16)
Instructor:   Ji-Hyun Lee
Professor and Director
Division of Quantitative Sciences & Biostatistics Shared Resources
Jihyun.Lee@ufl.edu
352-273-9079
Administrative Assistant:
Donna M. Johnson
johnsodm@ufl.edu
352-273-7137