Course Description

The FDA has been increasing their inspection coverage of the pharmaceutical laboratory as a result of significant GMP concerns with laboratory control and operations. This course has been designed to focus on the compliance and quality aspects of microbiological laboratory operations, with emphasis on current regulatory documents and those areas frequently cited by FDA investigators. The course format is lecture/discussion supplemented with problem solving exercises drawn from real life FDA citations. Topics include: regulatory requirements for performing bacterial endotoxins (LAL) testing, sterility testing current issues environmental monitoring and microbial limits/bioburden testing.

Course Instructor
This course is taught by Karen Z. McCullough, Director of Quality Operations at Roche Molecular Systems in Branchburg, NJ. She is acknowledged as a worldwide expert in the field of bacterial endotoxin testing (LAL). She is a Founder, Charter Member and Steering Commttee Member for the LAL Users Group. Ms. McCullough's interest is in the convergence of science and compliance in the application of the principles and practices of cGMP to pharmaceutical microbiology. Ms. McCullough holds a B.S. degree in Bacteriology from Rutgers University and a M.S. degree in Molecular Biology from the University of Oregon. She has been involved in LAL testing and pharmaceutical microbiology for over 30 years.

Learning Objectives

This course will provide attendees with a practical understanding of microbiological procedures, regulations and compliance requirements. Attendees will also acquire the technical and practical skills needed to audit and control microbiological test procedures and results.

Who Should Attend

This course is intended for quality assurance, Quality Control and Compliance personnel who have direct responsibility for performing, auditing and evaluating microbiological test methodologies and results. This course is suitable for both entry-level as well as advanced-level personnel, including supervisors and managers.

Course Outline

• The Bacterial Endotoxins Test (LAL) (Limulus Amebocyte Lysate)
  • Gel clot
  • Kinetic
  • Compliance issues
  • Interpretation
• Sterility Testing
  • Media growth promotion testing
  • Bacteriostasis/fungistasis
  • Interpretation
• Environmental Monitoring
  • Philosophy and practice interpretation
  • Methods
  • Interpretation
• Microbial Limits/Bioburden
  • Current USP requirements
  • International considerations/harmonization efforts
  • Technical issues
• Workshop