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.
- 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.
Visit Writing Effective SOPs for the 4 hour...
- 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.