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.

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Course Details & Registration Information

Elements of Current Good Manufacturing Practices in Biomanufacturing Processes
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
This course focuses on the application of current good manufacturing practices (cGMP) in the production of biopharmaceuticals. An overview of select topics will be covered from current regulations found in sections 210/211 of Title 21 of the Code of Federal Regulations (CFR) as well as the relevant ICH and FDA guidance documents.
Course Objectives
  1. Gain an understanding of the historical development of CGMPs and their current application in the production of biopharmaceuticals
  2. Become broadly familiar with select topics in section 210/211 of Title 21 of the Code of Federal Regulations along with other FDA and ICH guidance documents
  3. Understand how regulations apply to real-world situations through in-depth work sessions covering practices that are frequently in the production of biopharmaceuticals
  4. Practice the application of regulatory principles to procedure development and validation
  5. Be able to locate and identify relevant regulatory information through regulation/guidance searches
Outline of Instruction
  1. Day 1 Lectures
    A. The historical development of GMP regulations
    B. Outline of regulations and enforcement
    C. Quality
    E. Documentation and records
    F. Building and facilities
    G. Equipment
    H. Equipment maintenance, cleaning, calibration
    I. Validation
    J. Cleaning validation
  2. Day 1 Work Session: Procedures and validation
  3. Day 2 Lectures
    A. Production and in-process controls
    B. Materials management
    C. Packaging and labeling
    D. Laboratory controls
    E. Personnel
    F. Complaints and recalls
    G. Change control
    H. Computerized systems
    I. Cell culture and fermentation
    J. Regulations on biologics
  4. Work Session: Warning Letters- Becoming the FDA inspector
Contact Hours
Industry Standard, State, or National Certification
CE to CU Articulation
Text and Supplies Needed
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 80% or above
  2. Participation
  3. Completion of course exam with a minimum score of 70%
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