Good Manufacturing Practices for Bioprocesses
This course presents an in-depth discussion of the application of current good manufacturing practices (cGMP's) to the biotechnology industry. cGMP requirements, compliance, and adequate documentation will be addressed.
The course will include class lectures, library research projects, and short design projects. Discussion of current reference articles and case studies will also be included.
The latest available information on the FDA new GMP initiative in the 21st Century, including risk-based GMP's, will be discussed.
- Introduction to cGMP's: drugs and biologics, CFR publications, other guidelines
- cGMP requirements and compliance, buildings and facilities, bulk production
- Containment, NIH guidelines
- cGMP documentation requirements, raw materials and product specifications, test procedures
- Batch records and SOP's
- Facilities validation, process validation
- Laboratory controls, assay development, and validation
- Training requirements
- GMP considerations for multiproduct facilities
- Environmental monitoring
- International GMP's
- The FDA new GMP initiative
Who should attend
- Biotechnology professionals/biochemical engineers
- Industrial and government researchers
- Faculty and graduate students (engineering, chemistry, biology and pharmacy)
- Manufacturing and R&D staff
- Architects and engineers
- Regulatory affairs professionals
- Quality control/quality assurance professionals
Duration: 45 hours
Locations: Live Lecture at UMBC Main Campus and Distance Learning lectures downloaded online.
E-mail firstname.lastname@example.org or call (443) 692-6599:
- if you have any questions about this course,
- to be notified when this course and any closely related courses are scheduled for open enrollment,
- to request a quote for group training at your location or ours.