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 Medical Devices
Name
SEF-3001KG1
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
Intended Audience
All personnel working in the medical device industry including manufacture/production operators, quality control personnel, quality assurance personnel, and maintenance and engineering personnel.
Description
This course provides an overview of the Food and Drug Administration (FDA) principles, requirements, and expectations for compliance with Current Good Manufacturing Practices (CGMPs) related to medical device manufacture. This will include a review of FDA enforcement and the consequences of non-compliance. An introduction to ISO certification and the similarities to Quality Systems Regulations (QSR) will be discussed. The importance of Good Documentation Practices (GDP) with respect to CGMP compliance will be stressed.
Course Objectives
  1. Explain the regulatory definition of medical devices.
  2. Describe the FDA regulation of medical devices.
  3. Identify aspects of FDA oversight.
  4. Discuss Quality Systems Regulations.
  5. Compare ad contrast ISO 13485 and QSR.
  6. Discuss the mechanics of ISO certification.
  7. Implement Good Documentation Practices.
  8. Navigate the FDA website and resources.
Outline of Instruction
  1. Regulatory definition of medical devices
  2. Overview of medical device product types
  3. The role and responsibilities of the FDA in the regulation and oversight of medical devices
  4. Comparison of 21 CFR 820 (QSR) to ISO 13485
  5. Overview of good documentation practices
Contact Hours
4
CEU's
0.4
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Text and Supplies Needed
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 90% or above
  2. Participation
Accreditation/Special Approval Requirements
Intended Audience
All personnel working in the medical device industry including manufacture/production operators, quality control personnel, quality assurance personnel, and maintenance and engineering personnel.
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
Related Courses
  • Medical Devices, CGMPs and ISO Overview - SEF-414CL
  • Elements of Current Good Manufacturing Practices in Biomanufacturing Processes - SEF-79524
  • Good Documentation Practices and Data Integrity - SEF-211CL
Course Contact Information
Bionetwork Manager