QC Micro Skills for Biopharma

Course Descriptor

This comprehensive 3-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 as an introduction to the remaining classroom-based lectures and lab-based practical sessions, including Growth Promotion Testing and BIs, Environmental Monitoring and Water Testing, Microbial Identifications, and Adventitious Agents testing.  The course will also cover a regulatory overview of micro lab requirements as well as how to approach common lab deviations.

QC Micro Skills for Biopharma

SKU: QC Micro Skills for Biopharma Category:

2,250.00

Clear
Dates:
  • 09/06/2020 - 11/06/2020

    6 Places Remaining

  • 29/09/2020 - 01/10/2020

    6 Places Remaining

Fee:
€2250
Suitable 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

 

 

 

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