QC Micro Skills for Biopharma

Course Descriptor

This comprehensive 4-day course is designed to equip new QC analysts with the main theory and practical experience required to develop their skills in the microbiology laboratory. Classroom-based lectures on microbiology basics and the main aspects of contamination control will introduce the various hands-on sessions over subsequent days, covering basic micro culturing techniques, IDs and use of microscopes, water and in-process testing methods of bioburden and endotoxin / sterility testing for the support of manufacturing and utilities, as well as validation tests such biological indicators. The course will wrap up on the final day with sessions on the use of Quality Manangement Systems, GxP and Audits and Regulations.

QC Micro Skills for Biopharma

SKU: QC Micro Skills for Biopharma Category:

2,250.00

Clear
Dates:
  • 15/10/2019 - 18/10/2019

    5 Places Remaining

Fee:
€2250
Suitable for:

New recruits to QC who are looking to familiarise themselves with the theory and practical elements of standard Micro testing.
Lab management personnel who want to refresh their knowledge on testing protocols and requirements.
QA, Manufacturing or Engineering personnel who have an interest in what happens in the laboratories.

Who should attend

New recruits to QC who are looking to familiarise themselves with the theory and practical elements of standard Micro testing.
Lab management personnel who want to refresh their knowledge on testing protocols and requirements.
QA, Manufacturing or Engineering personnel who have an interest in what happens in the laboratories.

Key topics covered

  • Microbiology basics and contamination control for a biopharmaceutical manufacturing facility.
  • An overview of WFI generation system and aseptic water sampling techniques.
  • Environmental monitoring of a manufacturing facility.
  • Basic microbiology lab techniques including plate streaking, colony counting and microscopy.
  • Support testing performed by a microbiology lab including microbial identifications, growth promotion and processing of biological indicators.
  • Testing water samples, in-process samples and finished product for bioburden and endotoxin.
  • An introduction to Quality Management Systems and their use in responding to laboratory deviations. 
  • Regulation of the biopharmaceutical industry from a microbiology perspective.
  • An overview of GxP from a microbiology perspective.

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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