ComplianceOnline

Performing Investigations for Environmental Excursions

Instructor: Melissa Myers
Product ID: 701573
  • Duration: 60 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

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Read Frequently Asked Questions

This Webinar will discuss the modalities of proper investigations for environmental excursions and how to find the root cause and take appropriate preventive actions.

Why Should You Attend:
Environmental excursion investigations are complex and multidisciplinary and require the investigator to illicit information from multiple departments to aid in determining the true root cause. Excursions investigations are aided by a robust environmental trending program that should evaluate data for individual sites, rooms, suites and the normal microbial flora of the facility. Proper investigation encompasses manufacturing areas, classified areas and microbial testing laboratories. Failure to properly investigate environmental excursion to true root cause will not allow for appropriate and effective corrective actions. This leads to lack of environmental control of you manufacturing or laboratory operations.Ultimately, this may lead to product failures and possible regulatory actions or worse patient interactions.

Failure to properly investigate environmental excursion to true root cause will not allow for appropriate and effective corrective actions. This leads to lack of environmental control of you manufacturing or laboratory operations.Ultimately, this may lead to product failures and possible regulatory actions or worse patient interactions.

This presentation will cover the investigation process from initiation and immediate response to organization, compilation of data, analyzing the data recovered to drawing conclusions and designing corrective actions.

Areas Covered in the Seminar:

  • Why investigate environmental excursions.
  • Identifying an excursion - now what do I do?
  • Compling all necessary information.
  • Analzying information (including trend analysis).
  • Driving to root cause.
  • Defining appropriate corrective actions.
  • Evaluating effectiveness of corrective actions.

Who Will Benefit:

This webinar will provide valuable assistance to regulated manufacturing and laboratories that support microbial testing.
  • Microbiologists
  • Quality Control personnel
  • Environmental Monitoring personnel
  • 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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