Introduction toIndustrial Biotechnology:

Working in a Regulated EnvironmentCOURSE DESCRIPTION: This is an entry-level course for the development of skills needed

to function in today’s biotechnology industry. The course covers two tracks, Processes & Facilities andRegulatory Affairs, Quality Assurance, & Quality Control, using a blend of on-line modules, classroomexercises, and wet-lab skills. This course integrates concepts in processes and facilities with qualitycompliance to simulate the work experience in a regulated environment.

Students will be asked to apply project managment skills in the production or regulation of a standardbiotechnology-based process. The two topics covered will include:

1Processes and Facilities

Building Systems• Equipment (Maintenance, Calibration)• Raw Material (Sourcing, Storage)• Aseptic Processing• Manufacturing•

2Regulatory Affairs, Quality Assurance,and Quality Control

cGMP’s, GLP’s, GCP’s• FDA Organization Structure (Overview)• Regulatory Compliance and FDA Inspections• Documentation (Forms, SOPs, Batch records)• Validation, Sampling, & Testing Methods•

Each student will have the opportunity to complete both tracks of study. A 40 hour industry recognized certificate, documenting 16 hours of online modules and 24 hours of wet lab, will be issued upon completion.

?? ??Who should attend: This course is intended for bothcurrent employees of biotechnology or individuals with aScience or Math background who are interested in a careerin industrial biotechnology.

Fees: All accepted trainees will have fees paidby a Workforce Florida Training Grant

To enroll: Mail/Fax back a completed enrollment form (page 2 of this pdf)

Part IOctober 21-23, 2008

Tuesday, Wednesday & Thursday1:00 p.m. - 5:00 p.m.

Part IIOctober 28-30, 2008

Tuesday, Wednesday & Thursday1:00 p.m. - 5:00 p.m.

Employ Florida Banner Center for Biotechnology, Florida Community College, Advanced Technology Center

For more information or any questions,contact: Chris Bush at (904) 598-5625 or email cbush@fccj.edu

TRAINING ENROLLMENT FORMMAIL FORM TO:

Florida Community College, Advanced Technology Center401 W. State Street, Jacksonville, FL 32202 Attn. Chris Bush

PHONE: (904) 598-5625

FAX:

(904) 632-3095 EMAIL: cbush@fccj.edu

NAME: ___________________________________________________________________________________________

ADDRESS: ________________________________________________________________________________________

CITY: _________________________________________________ STATE: _______ ZIP: ______________________

EMAIL: _______________________________________________ PHONE: __________________________________

CHECK BEST CONTACT METHOD: EMAIL PHONE ( DAY AFTERNOON EVENING)

ARE YOU A RESIDENT OF FLORIDA: YES NO ARE YOU OVER 18: YES NO

Voluntary Personal Information:

GENDER: MALE FEMALE DATE OF BIRTH: ___________________________

RACE: CAUCASIAN AFRICAN AMERICAN HISPANIC ASIAN OTHER: ____

Attendance to both sections is required

HIGHEST DEGREE EARNED: HS AS/AA BS/BA MS/MBA PhD Other: ________

ARE YOU CURRENTLY EMPLOYED: YES NO

HAVE YOU PREVIOUSLY WORKED IN A BIOTECHNOLOGY/SCIENCE FIELD: YES NO*

IF YES, DESCRIBE:

*If you replied no, it is recommended you complete two online modules of the Biotechnology industry before completing your enrollment. Please log onto the Education Center s̓ web site (http://cerhb.rgp.ufl.edu/education_index.html), under the instructional materials tab will be two modules entitled, Biotech Introduction and Day in the Life of a Technician.

1) How did you hear about the Employ Florida BANNER Center for Biotechnologyʼs Education Center?

2) What do you hope to achieve by completing this training?

3) Please write a brief personal statement outlining your work experience along with your short and long term goals.

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FCCJ - Part IOctober 21-23, 2008Tuesdays, Wednesday & Thursday1:00 p.m. - 5:00 p.m.

FCCJ - Part IIOctober 28-30, 2008Tuesdays, Wednesday & Thursday1:00 p.m. - 5:00 p.m.