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
Elements of Supplier and Internal Quality Audits
Name
SEF-219CL
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
Intended Audience
People in the field of medical device production quality assurance and/or auditing.
Description
Regulatory authorities expect ongoing assessments of all processes and materials, and this course will help you understand regulatory requirements and expectations for audits. You will also learn the different types of audits, their purposes, and the investigatory and assessment tools used in audits – as well as how to plan, conduct, and report audits. The course is appropriate for those new to auditing, experienced auditors taking on lead auditor responsibilities, and senior management responsible for resourcing audit efforts and assessing the information obtained.
Course Objectives
  1. Prepare participants to classify, plan, execute, and close out an audit while adhering to the guidance and expectations of medical product regulators and industry.
Outline of Instruction
  1. Introduction to Auditing
  2. Audit Classifications
  3. Medical Device and Pharmaceutical Regulations, Requirements, and Expectations
  4. Auditor Skills and Competencies
  5. The Audit Process
  6. Group Workshop
Contact Hours
8
CEU's
0.8
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 80% or above
  2. Participation
Accreditation/Special Approval Requirements
Intended Audience
People in the field of medical device production quality assurance and/or auditing.
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
Related Courses
Course Contact Information
Bionetwork Manager