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► ProgramsGood Manufacturing Practices for Bioprocesses (Online, Self-Paced)

Good Manufacturing Practices for Bioprocesses (Online, Self-Paced)

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.

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

Audience

  • 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


Group Training Available

UMBC Training Centers can deliver any of our courses in a group training environment at our facilities or yours. Group training can be an effective and economical method to quickly assure competency and consistency of knowledge and skills within an organization or department.