Laboratory Controls-Microbiology

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.

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

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

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 will be selected from the following:

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