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
Last Recorded Date: Nov-2010

Training CD / USB Drive

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

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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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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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