Course Descriptor
This 3.5 day course is designed to equip QC Microbiology analysts with the main theory and practical experience required to develop their skills in a GMP biopharmaceutical microbiology laboratory. The course will cover microbiology basics in the classroom-based lectues and lab-based practical sessions, including Growth Promotion Testing and BI Processing, Environmental Monitoring, Water Sampling, Bioburden and Sterility testing (using rapid methods) & Endotoxin testing (using recombinant Factor C technology, Microbial Identifications, and Virus and Mycoplasma testing. The course will also cover data trending and an overview of how to approach deviations and investigations.
Course delivery method: Blended Online and Onsite at NIBRT
- Three mornings online theory
- Two days NIBRT practicals
Course Costs:
- Three mornings online theory only: €1,425
- Full course of Three mornings online theory and Two days NIBRT practicals: €3,325
| March Delivery Online Theory – 22nd, 23rd & 24th Full course – 22nd, 23rd & 24th (online theory) + 28th & 29th (onsite practicals) |
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September Delivery |
QC Micro Skills for Biopharma
€1,425.00 – €3,325.00
Dates:
- 22/03/2023 - 24/03/2023
Out of stock
- 22/03/2023 - 29/03/2023
Out of stock
- 20/09/2023 - 22/09/2023
3 Places Remaining
- 20/09/2023 - 27/09/2023
8 Places Remaining
Fee:
€3325Suitable for:
- QC Micro personnel looking for a refresher or introduction to the relevant theory and practical elements of common microbiology lab tests.
- Lab management personnel who want to refresh their knowledge on testing protocols and regulatory requirements.
- QA, Manufacturing or Engineering personnel who have an invested interest in what happens in a QC Micro lab.
Who should attend
- QC Micro personnel looking for a refresher or introduction to the relevant theory and practical elements of common microbiology lab tests.
- Lab management personnel who want to refresh their knowledge on testing protocols and regulatory requirements.
- QA, Manufacturing or Engineering personnel who have an invested interest in what happens in a QC Micro lab.
Key topics covered
- Microbiology basics, with a focus on commonly found microbes in biopharmaceutical plants.
- Regulations for QC Micro, including audit readiness in the lab
- Basic personnel hygiene and aseptic technique required when sampling and testing
- Lab support tests including growth promotion of media and processing of biological indicators
- Environmental monitoring risk assessments and sampling execution
- Water purification systems; how and when they are sampled and how samples are tested
- Microbial identification techniques used in microbiology labs; a comparison of traditional techniques versus modern techniques
- Adventitious Agents Testing, with a focus on in-house mycoplasma testing techniques
- How to handle and approach common deviations that can arise in the laboratory
Learning outcomes
Upon completion of this course, you will be able to:
- Describe the importance of microbiology in biopharmaceutical manufacturing.
- Describe the main principles of contamination control within the manufacturing facility.
- List the main roles and responsibilities of the QC Microbiology lab.
- Describe the main environmental monitoring sampling techniques and operate particle counting and viable monitoring equipment.
- List the main components of a WFI generation system.
- Aseptically take samples from a WFI generation system and submit these samples to the laboratory for testing.
- Describe bioburden and endotoxin testing techniques for water samples, in-process samples and finished product.
- Perform basic colony morphology identifications, gram staining procedures and microscopic identifications.
- Perform lab support tests such as growth promotion testing and processing of biological indicators.
- Describe how Quality Management Systems are used to respond to laboratory investigations.
- List the main regulations and guidelines governing microbiology practices in a biopharmaceutical plant.
- Describe the main GLP, GDP and GMP practices from a laboratory perspective.
Assessment
A competency based assessment will be undertaken at the end of the course. This will certify proficiency in the theory and practical skills.
