BioNetwork Capstone Certificate in Medical Device Quality Systems

This certificate demonstrates successful completion of a series of courses designed to provide the student with experience in quality systems related to the manufacturing of medical devices. Upon successful completion of the series, participants will recognize the regulations that drive cGMPs in a medical device production environment, demonstrate proper SOP writing, be able to follow good documentation practices in all cGMP-generated records, effectively conduct investigations and be able to review and conduct external and internal audits. Participants will be adequately prepared to assist in U.S. Food and Drug Administration or other regulatory audits of their facility.

Who should earn this certificate?

  • New and incumbent biomanufacturing operators, process technicians and entry-level professionals in the biotechnology, pharmaceutical and life science industries
  • Individuals retraining and transitioning from other industries into biomanufacturing jobs
  • College students and recent graduates of life sciences programs, including Agricultural Biotechnology, Agriculture, Biology, Biopharmaceutical Technology, Bioprocess Technology, Biotechnology, BioWork, Chemistry, Engineering, Laboratory Technician, Microbiology, Pharmaceutical Technology and Quality Assurance
  • Students who have earned or are pursuing a BioWork Certificate to enhance their job-related skills

Course requirements

SEF-3001KN1
Writing Effective SOPs
4 hours
SEF-3001Kl1
FDA Audit Preparation
8 hours
SEF-219CL
Elements of Supplier
and Internal Audits
8 hours
SEF-3001KL1
Good Documentation Practices and Data Integrity for Medical Devices
8 hours
SEF-3001KM1
Deviations, Root Cause Analysis
and CAPA Resolution
8 hours

 

One of these courses is required as well

SEF-414CL
Medical Devices, CGMPs
and ISO Overview
(recommended for those new to GMPs, ISO or medical devices)
16 hours
SEF-3001KG1
CGMP Overview of Medical Devices
(best as a refresher)
4 hours

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.

Workforce Continuing Education
Financial Resources
and Student Support

About BioNetwork Capstone Center

BioNetwork is an initiative of the North Carolina Community College System designed to promote the growth of life science industries, education and employment opportunities in North Carolina. The Capstone Center is hosted by Wake Tech Community College and located in the Golden LEAF Biomanufacturing Training and Education Center on North Carolina State University's Centennial Campus in Raleigh. Facilities include a certified cleanroom suite and state-of-the-art laboratories. Courses are led by faculty with industry expertise, allowing a unique and exceptional training opportunity.  Experientially oriented courses provide an array of critical hands-on experiences and problem-solving skills necessary for working within a cGMP-focused environment.

Course details and registration information

For questions about the certificate or these courses, email [email protected].

CGMP Overview for Medical DevicesSEF-3001KG1
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...
Elements of Supplier and Internal Quality AuditsSEF-219CL
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 assess...
FDA Audit PreparationSEF-3001KI1
This course is designed to help in creating an environment of preparedness and a culture of quality assurance by raising the awareness of FDA compliance in regulated facilities. Maintaining current knowledge of preparation steps, do’s and don’ts, documentation completeness a...
Good Documentation Practices and Data IntegritySEF-211CL
This course presents the regulatory requirements and best practices for pharmaceutical documents, documentation, and record-keeping. It includes a review of the differences between documents and records; the typical ISO 9001 document hierarchy, as well as an explanation and...
Medical Devices, CGMPs and ISO OverviewSEF-414CL
This course provides a broad overview of the United States Food and Drug Administration (FDA) principles, requirements, and expectations for compliance with the Current Good Manufacturing Practices (CGMPs) for medical device manufacturing. We will review the regulatory defin...
Writing Effective Standard Operating Procedures (SOPs)SEF-413CL
Students will learn how to write an effective Standard Operating Procedure (SOP) as well as why these are a required and essential component of documentation systems in regulated industries. Discussion will include the functional areas in which SOPs are needed, the qualities...
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