ComplianceOnline

Setting up a cGMP compliant Microbiology Laboratory

Instructor: Melissa Myers
Product ID: 701572
Training Level: Basic to Intermediate
  • Duration: 70 Min

recorded version

$349.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$600.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will help companies that are currently setting up a microbiology laboratory as well as current microbiology laboratories to evaluate themselves against the current practices.

Why Should You Attend:
Requirements for operating a microbiology laboratory to support cGMP manufacturing of drugs is more complex and has specific requirements when compared to that of a chemistry laboratory. There are significant expenses associated with maintenance and understanding of the industry expectations is a must.

Because of the inherent variability in microbial data, proper quality systems must be in place to help ensure the reliability and reproducibility of the results obtained from the laboratory. The quality systems required include control of media, control of test organisms, and control of equipment, proper aseptic technique and training of personnel. Equipment needs are also significantly different than that of a chemistry laboratory. Because results may be difficult to interpret due to the inconsistency of results (from lack of organisms lack of homogeneous distribution, environmental factors, etc.), procedures specific to microbial data may be required as well as more testing or environmental controls.

Attend this Webinar to have a through understanding of best practices related to programs required, the equipment needs, testing controls, trainings and OOS investigations for setting up a microbiology laboratory.

Areas Covered in the Seminar:

  • Microbial testing performed by a microbiology laboratory to support manufacturing.
  • Equipment need.
  • Testing controls.
  • Evaluating results.
  • OOS investigations.
  • Training.

Who Will Benefit:

This webinar will help companies that are currently setting up a microbiology laboratory as well as current microbiology laboratories to evaluate themselves against the current practices.
  • Microbiology personnel
  • QC microbiologist
  • QC managers
  • Quality Assurance

Instructor Profile:
Melissa Myers, Ph.D. is Manager of Microbiology at Catalent Pharma Solutions, a leading provider of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies. Melissa has managed the full service microbiology laboratory for over 11 years. Additionally, she led the successful remediation of the environmental monitoring programs for an aseptic manufacturing plant under FDA warning letter.

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