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
CGMP Overview for Pharmaceuticals
Name
SEF-3001KH1
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
Intended Audience
Manufacturing Technicians, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, Maintenance/Engineers
Description
An overview of Current Good Manufacturing Practices (CGMP) fundamentals used by pharmaceutical and biomanufacturing companies. CGMP exists to protect the health and safety of patients and consumers which supports the mission of the Food and Drug Administration (FDA). This course equips professionals whose responsibilities depend on operating in CGMP and regulated facilities.
Course Objectives
  1. Define the elements of current Good Manufacturing Practices (CGMP) for biomanufacturing and pharmaceutical production.
  2. Explain how CGMP helps regulated companies comply with the law: Part 21 of the Code of Federal Regulations (21 CFR 211).
  3. Understand the importance of current Good Documentation Practices (CGDP) for pharmaceuticals and Part 11 of the Code of Federal Regulations (Electronic Record Keeping).
  4. Recognize the consequences of failing to comply with CGMP.
Outline of Instruction
  1. The mission of the FDA
  2. The quality assurance role
  3. Personnel and organization
  4. Buildings and facilities
  5. Equipment
  6. Control of components, drug product containers, and closures
  7. Production and process controls
  8. Packaging and labeling
  9. Holding and distribution
  10. Laboratory controls
  11. Records and reports
  12. Return and salvaged drug products
  13. Complaints and recalls
  14. Good Documentation Practices (GDP)
  15. Computer systems (Part 11)
  16. Regulatory enforcement
Contact Hours
4
CEU's
0.4
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Text and Supplies Needed
Provided by BioNetwork
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 100%
  2. Participation
Accreditation/Special Approval Requirements
Intended Audience
Manufacturing Technicians, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, Maintenance/Engineers
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
  • Manufacturing Technicians
  • Team Leaders and Supervisors
  • Quality Control Personnel
  • Quality Assurance Personnel
  • Maintenance/Engineers
Related Courses
  • Medical Devices, CGMPs and ISO Overview - SEF-414CL
  • Elements of Current Good Manufacturing Practices in Biomanufacturing Processes - SEF-79524
Course Contact Information
Bionetwork Manager