Certificate in Medical Device Quality Systems

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 will be able to review and conduct external and internal audits. Participants will be adequately prepared to assist in an FDA or other regulatory audits of their facility.

Audience

  • New and incumbent process, laboratory, and utility technicians and entry-level professionals in the biotechnology and medical device industries.
  • Individuals retraining and transitioning from other industries into biomanufacturing jobs.
  • College and community college students or graduates of programs in the life sciences, such as: 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.
BioNetwork Capstone Certificate in Medical Device Quality Systems
Course Requirements
CGMP Overview for Medical Devices

This course provides an overview of the Food and Drug Administration (FDA) principles, requirements, and expectations for compliance...

4 hours
Deviations, Root Cause Analysis and CAPA Resolution

This course is designed to introduce technicians and professionals to the principles and regulatory requirements of current drug,...

8 hours
Elements of Supplier and Internal Quality Audits

Regulatory authorities are increasingly expecting on-going, competent assessments of internally and externally sourced processes and...

8 hours
FDA Audit Preparation

FDA Audit Preparation is designed to help create an environment of preparedness to instill a culture of quality assurance by raising the...

8 hours
Good Documentation Practices for Medical Devices

This course presents the regulatory requirements and best practices for medical device documents, documentation, and record keeping.  ...

8 hours

This course provides a broad overview of the United States Food and Drug Administration (FDA) principles, requirements, and expectations...

16 hours

College

Certificate Hours
60 +
There are additional or optional course requirements.
One of these Courses are Required
  • CGMP Overview of Medical Devices is best as a refresher.
  • Medical Devices, CGMPs and ISO Overview is recommended for those new to GMPs, ISO, or medical devices.
CGMP Overview for Medical Devices

This course provides an overview of the Food and Drug Administration (FDA) principles, requirements, and expectations for compliance...

4 hours

This course provides a broad overview of the United States Food and Drug Administration (FDA) principles, requirements, and expectations...

16 hours