Biotechnology

Wake Tech offers a variety of non-degree, short classes and certificate training programs in the biotechnology field, including hands-on training in biomanufacturing and biopharmaceutical operations in a simulated industrial, current good manufacturing practices (cGMP) environment.


Course Details & Registration Information

Course
Good Laboratory Practices: FDA and EPA Regulations
Name
SEF-79724
Available Classes
    Section Location Begin Date End Date Instructor Price Seats Available/Total Seats
215015 BTEC BioNetwork Capstone Learning Center 12/04/2019 12/05/2019 G. Picard $130.00 8/12
Description Course Outline Requirements Intended Audience More Details
Description
Lectures will present an overview of Good Laboratory Practice Standards (as defined by the EPA, 40 CFR Part 160 of the Federal Register, and the FDA, 21 CFR Part 58 of the Federal Register) for conducting acceptable regulatory laboratory studies in support of both pesticide and drug registrations. The course includes exercises in the evaluation of protocols, using SOPs for the preparation of standard solutions and the rejection of data, and the evaluation of laboratory labels. Students will gain a broad understanding of the requirements reinforced by class exercises for conducting acceptable FDA and EPA studies.
Course Objectives
  1. Become familiar with the EPA and FDA Good Laboratory Practice guidelines that are necessary to produce acceptable regulatory studies
  2. Gain an understanding of the documentation guidelines required for the generation of acceptable EPA and FDA product registration safety studies
  3. Gain hands-on experience evaluating protocols, laboratory labels, and SOPs
Outline of Instruction
  1. Introduction and definitions
    a. Personnel
    b. Testing facilities
    c. Equipment
    d. Standard Operating Procedures
  2. Lab: SOP exercise
  3. Test, control, and reference substances
  4. Protocols
  5. Good freezer stability protocol, bad protocol exercise, and discussion
  6. Study conduct exercises
    a. Principal investigator role example - typical data forms
    b. Study director role play- rejection of data exercise using SOP ES.A.0601.01
    c. Quality assurance auditor role play - evaluation of lab labels produced by instructor and class participants during SOP exercise
  7. Final reports
  8. Archives
  9. EPA report of GLP Compliance Status in the US
  10. Course exam
Contact Hours
8
CEU's
0.8
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
High School Diploma, Biowork or equivalent
Text and Supplies Needed
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 80% or above
  2. Participation
  3. Achieve a minimum score of 70% on course exam
Accreditation/Special Approval Requirements
Intended Audience
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
Related Courses
Course Contact Information
Bionetwork Manager