QC Micro Skills for Biopharma
Overview
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 lectures and lab-based practical sessions, including Growth Promotion Testing and BI Processing, Environmental Monitoring, Water Sampling, Bioburden and Sterility testing (using rapid micro methods) & Endotoxin testing (using recombinant Factor C technology, Microbial Identifications, and Mycoplasma testing. The course will also include an overview of how to approach deviations and investigations.
Key topics covered
- Microbiology basics, with a focus on commonly found microbes, and their potential entry into 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
- Endotoxin testing using Recombinant Factor C technology as well as cartridge-based Rapid Method.
- 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
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.
What do Attendees Obtain on Completion?
An MCQ quiz will be taken at the end of the course. Attendees will receive results and a certificate of completion.
Register
Course Format
Blended; Online & Onsite Training
- 3 mornings of online theory
- 2 days NIBRT practicals
Dates & Price
Dates:
- Course 1 01/04/2025 - 03/04/2025
NIBRT Online Course (no practicals included)
€1,495.006 Places Remaining
- Course 2 01/04/2025 - 08/04/2025
Full course 01 – 03 Apr (Online) 07- 08 Apr (Onsite)
€3,485.006 Places Remaining
