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BIOTECHNOLOGY

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BIOTECHNOLOGY

CCBC and Biotechnology
CCBC prepares students for the intensive research, government oversight, recordkeeping, and specialized production techniques that today's biotechnology sector requires. Whether it's laboratory work, quality control and assurance tasks, manufacturing and production or bioinformatics, CCBC equips its biotechnology students with the tools that the industry demands.

Biotechnology and Biomanufacturing Degree / Certificate Programs at CCBC
Biotechnology and biomanufacturing programs at CCBC are designed to provide students with a foundation in biotechnology concepts focusing on the bioscience laboratory. Students may choose to enroll in the certificate or A.A.S. degree program in biotechnology and biomanufacturing.

Short-Term Intensive Courses at CCBC
Classes focusing on key areas of biotechnology are offered through the Baltimore Pharma Bio Training Partnership in conjunction with the University of Maryland Baltimore County, BioTechnical Institute of Maryland, Inc., and the Baltimore County Department of Economic Development. Past offerings include:

Additional courses will be available in

  • Validation Processes
  • Technical Writing and Communications
  • Automation Fundamentals

Introduction to Current Good Manufacturing Practices for the Pharmaceutical and Biotechnology Industry
Completing the course will give you an understanding of the critical role that current Good Manufacturing Practices (cGMP) play in maintaining the safety of medicines. You'll also understand how cGMPs impact various stages of the production process, learn where information on the cGMPs is published, be familiar with international cGMPs and efforts to harmonize. Learn about real-world examples that illustrate the cGMPs in action and discuss possible ways that noncompliance of the cGMPs can be corrected. The course is offered in a lecture/discussion format.

Current Good Manufacturing practices Advanced Seminar
This session provides more in-depth coverage of the subject of cGMPs. The seminar includes information on the Food and Drug Administration's (FDA) recent guidance on Quality Systems, GMPs for the 21st century, Risk-based GMPs and other current topics. GMPs as applicable to small molecules are also discussed. Participants are given the opportunity to work together in round-table discussions, using what they have learned to formulate answers to various case studies.

Laboratory Documentation
This course will prepare biotechnology and bioscience workers in Documentation Requirements and Standards. The goal is to present and clarify the reasons for documentation controls and to provide FDA rules surrounding quality documentation.

Aseptic Processing
This introduction to the processing of pharmaceuticals and biotechnology products in an aseptic environment will present the use of aseptic techniques in the pharmaceutical and biotechnology industry using real-world examples. Case studies will illustrate the importance of proper techniques and adherence to validated procedures and methods and how deviations may affect product quality. The course is offered in a lecture/demonstration format.

Change Control: A Practical Workshop
This course is intended to highlight the need for a proper change control program that encompasses all GMP or application-related changes and provide insight to the necessary involvement of various disciplines within the company. All changes within in the pharmaceutical manufacturing and regulatory environment must be evaluated for potential impact on product quality or validated systems. It is critical that personnel understand the change control process, proper involvement, and evaluation of changes and associated documentation.

Open enrollment, customized, and on-site training is available.
Contact: e-mail: appliedtrain@ccbcmd.edu or call Jay Bouis at 443-840-4428

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