Laboratory Controls-Microbiology


Virtual Learning
February 13 – 15, 2024

12 hrs VILT, 4 hrs self-paced

3 days


About This Courses

Laboratory controls are critical to the decision making of the Quality Unit as they form a critical part of the data to help with batch release decisions.

This highly interactive course, laboratory controls- microbiology is part of NSF’s training program for the Certificate in Pharmaceutical Quality, linked to the US FDA’s 6 systems approach.

Our virtual instructor-led training will be delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. Full details will be sent following registration.

Key Learning Objectives

On completion of this course, you will know and understand:

  • The characteristics of microorganisms
  • Microbiological methods
  • How to sample, isolate and identify microorganisms
  • Development of environmental monitoring and contamination control strategies

Course Outline

Microbiological Methods:

  • Sampling
  • Isolation and enumeration (counting)
  • Identification (how and when to identify microorganisms)
  • Tests for sterility and preservative efficacy
  • Monitoring methods

Assessment of Microbial Contamination Risks:

  • Contamination control strategies
  • Microbiological aspects of good plant and process design
  • How to use risk assessment and hazard analysis to identify and remove contamination risks

Removal of Microorganisms:

  • Good disinfection practices
  • Sterilisation and filtration

Decision Making and Problem Solving

  • How to interpret microbiological data and trends
  • How to identify the root cause of contamination incidents
  • How to use risk assessment techniques to assess the impact of “failures” on product quality and patient safety

Who Should Attend

Pharmaceutical Quality Unit and Technical Professionals

  • Quality professionals starting in their Quality Assurance or Quality Control roles who want to increase their broad understanding of laboratory controls.
  • Staff whose role requires them to understand laboratory processes such as auditors, those with quality oversight responsibilities and regulators.
  • Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development.

Course Tutors

Course tutors will be selected from the following:

  • Tony Mayhall
  • Shannon Wills
  • Linda Linke
  • Joe Day