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
Last Recorded Date: Feb-2010

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: +1-650-565-8542

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.

Follow us :
Validation, Verification and Transfer of Analytical Methods
Upcoming In-person Seminars by EX-FDA OFFICIALS

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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