Certificate in Pharmaceutical Quality Systems

Certificate in Pharmaceutical Quality Systems

This certificate demonstrates successful completion of a series of courses designed to provide the student with experience in biomanufacturing quality systems. Upon completion of this certificate, participants will demonstrate a familiarity with the regulations that drive pharmaceutical manufacturing CGMPs, proper SOP construction and revision, the ability to follow good documentation practices in all CGMP generated records, and the elements needed to effectively conduct investigations. Participants will be able to review and conduct external and internal audits and assist in 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 Pharmaceutical Quality Systems
Course Requirements
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 Current Good Manufacturing Practices (cGMP) in Biomanufacturing Processes

Understand the fundamentals of current Good Manufacturing Practices (CGMP) for Biomanufacturing. CGMP exists to protect the health and...

16 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 and Data Integrity

Are you responsible for preserving documents or for ensuring that your company’s data is complete and correct?

Stay on top of...

8 hours

College

Certificate Hours
56