Pharmaceutical Microbiology for Non-Microbiologists
Course
In Barnard Castle
Description
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Type
Intensive workshop
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Level
Intermediate
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Location
Barnard castle
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Class hours
16h
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Duration
2 Days
Controlling microbiology throughout the manufacturing process is a key success factor for production. Microbiology is unseen and data is history, effective control requires all disciplines to be involved in the control measures and any out of specification investigations. Therefore, all key personnel should have a thorough understanding of microbiology.
This course is designed to give non-microbiologists a comprehensive introduction to microbiology so that they can engage in the required control measures, investigations and corrective actions.
Important information
Documents
- Pharmaceutical_Microbiology_for_Non-Microbiologists_V1.4.pdf
Facilities
Location
Start date
Start date
About this course
At our Microbiology for Non-Microbiologists Training Course delegates will:
• Develop a sound understanding of basic pharmaceutical microbiology
• Be able to identify microbial hazards
• Learn how to reduce contamination
• Learn the requirements for sterile and non-sterile product manufacture
• Be able to constructively participate in microbiological risk assessments
• Be able to participate in out-of specification investigations
• Review microbiological data and understand the methods of analysis control
• Understand Gram positive and gram negative bacteria, and gram staining
• Identify Bacteria (bacteriology and mycology)
• Learn about Spores and spore forming microorganisms
• Read micro-organisms on Agar plate
The course provides an introduction to pharmaceutical microbiology and is applicable to anyone who works in a sterile manufacturing operation who is not directly involved in microbiology or is new to this area. This includes persons who review data but are not qualified microbiologists.
This two-day course combines classroom-based lectures with practical workshops in our approved MHRA laboratory, and aims to give delegates a solid introduction to microbiology in the context of pharmaceutical manufacture. Throughout the course, data interpretation will be practised and the consequences of misinterpretation discussed.
Reviews
Subjects
- Microbiology
- Microbiology in Manufacturing Processes
- Sterile Product Manufacture
- Micro Limit Testing
- Monitoring Methods
- Sampling Methods
- Isolation
- Counting
- Interpretation of Data
- Bacterial Identification
- Spores
- Reading Plates
- Control Measures
- Regulatory Expectations
Teachers and trainers (1)
Marcus Booth
Director of Training and Consultancy
Over the last 27 years we have trained thousands of people within the pharmaceutical, biotech, medical device and health care industries. Honeyman courses continue to remain popular because they provide delegates with a sound understanding of the scientific principles associated with each technical discipline and the opportunity to put the principles into practice during interactive workshops, demonstrations and discussion sessions. We all actively work within industry and so provide pragmatic current best practice to allow companies to cGMP requirements and regulatory expectations.
Course programme
- The importance of microbiological data and control in pharmaceutical and medical device manufacture
- The microbiological spectrum
- The microbiology of concern to manufacturing processes
- Sources of microbiological contamination
- Micro requirements for sterile and non-sterile product manufacture
- Micro limit testing
- Monitoring methods: sampling methods, isolation and counting
- Interpretation of microbiological data
- Gram positive and gram negative bacteria, and gram staining
- Bacterial identification (bacteriology and mycology)
- Spores and spore forming microorganisms
- Reading plates
- Out-of-specification investigations
- Control measures
- Regulatory expectations
Pharmaceutical Microbiology for Non-Microbiologists