Biotechnology

Wake Tech offers a variety of non-degree, short classes and certificate training programs in biotechnology, including hands-on training in biomanufacturing and biopharmaceutical operations in a simulated industrial, current good manufacturing practices (cGMP) environment.

BioWork Process Technician
BioNetwork Training
Pharmaceutical Quality Systems Certificate
Medical Device Quality Systems Certificate

For those interested in earning a degree to work in the biotech industry, visit Wake Tech's Biotechnology Department.

Financial assistance available

Workforce Continuing Education offers financial assistance for many workforce training programs through the Propel program and other resources. Email [email protected] for more information.

Course details and registration information

Back to courses
Course
Good Documentation Practices for Medical Devices
Name
SEF-3001KL1
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
Intended Audience
Manufacture/Production Operators, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, Maintenance/Engineering Personnel
Description
This course presents the regulatory requirements and best practices for medical device documents, documentation, and record keeping. It covers the differences between documents and records, the ISO 9001 document hierarchy and appropriate content for each document level, record-keeping requirements (including for 21 CFR Part 11), and the appropriateness of Excel spreadsheets for record keeping. The course also reviews general good documentation practices, incorporating the requirements of the FDA's Guide to Industry Data Integrity and Compliance with CGMP.
Course Objectives
  1. Understand FDA required documents and record requirements for medical devices.
  2. Understand how to compliantly record and maintain data whether in hard-copy or electronic format.
  3. Participants will learn regulatory expectations for data accuracy, review and integrity assurance.
Outline of Instruction
  1. FDA's requirements for documents and record keeping defined in 21 CFR 820 and ISO 13485.
  2. Differences, usage and purpose of documents typically found in the medical device industry.
  3. Good documentation practices as well as common errors and data omissions that occur in medical device documentation.
  4. Electronic signature and electronic record keeping requirements of 21 CFR Part 11.
  5. Regulatory definition of raw data and the emerging regulatory expectations for data integrity.
Contact Hours
8
CEU's
0.8
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
Manufacture/Production Operators, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, Maintenance/Engineering Personnel
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
  • Manufacture/Production Operators
  • Team Leaders and Supervisors
  • Quality Control Personnel
  • Quality Assurance Personnel
  • Maintenance/Engineering Personnel
Related Courses
Course Contact Information
Bionetwork Manager
Back to courses