Laboratory Controls - Microbiology

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About This Course

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