Course Description | Instructor Information | Biotech Home

Overview

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.

Lecture Topics

• 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

Price: $1,195.00

Locations: Live Lecture at UMBC Main Campus, Video Transmission to NCI-Frederick Conference Center in Frederick, MD, and Distance Learning lectures downloaded online.

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