Course
Elements of Medical Product Auditing
Name
SEF-146CL
Available Classes
Not currently offered.
Intended Audience
People in the field of medical device production quality assurance and/or auditing.
Description
Regulatory authorities are increasingly expecting on-going, competent assessments of internally and externally sourced processes and materials. This course provides foundational information on regulatory requirements and expectations for audits as well as the different types of audits and their purposes. Additional information includes how to plan, conduct, and report audits as well as the investigatory and assessment tools used in audits. Course material is appropriate for personnel new to auditing, experienced auditors that are assuming lead auditor responsibility, and senior management responsible for resourcing audit efforts and assessing the information obtained from those audits.
Course Objectives
- 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
- Introduction to Auditing
- Audit Classifications
- Medical Device and Pharmaceutical Regulations, Requirements, and Expectations
- Auditor Skills and Competencies
- The Audit Process
- 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
- Attendance 80% or above
- 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
capstonecenter@waketech.edu