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Conducting a risk assessment for objectionable microorganisms

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This webinar on Objectionable Micro-organisms will provide examples of objectionable microorganisms and will review specific actions to take when one is found. It will also review how to conduct an effective risk analysis to mitigate the risk they present.

Speaker
Instructor: Frank Settineri
Product ID: 701532

Why Should You Attend:
GMPs require objectionable microorganisms to be minimized in pharmaceutical and biopharmaceutical manufacturing facilities. Unfortunately they do not provide a list of objectionable microorganisms; in fact objectionable microorganisms are not listed anywhere - it's up to each manufacturing site to determine what is objectionable, based upon the products that are produced in the facility. This is not an easy task and can only be accomplished by conducting a risk assessment for each objectionable microorganisms that are found.

This course provides attendees with an understanding of the role objectionable microorganisms play in maintaining the safety and quality of products. We will take participants through a step-by-step process of determining how to assess the risk of an objectionable microorganism, how an objectionable microorganisms affect the safety and quality of in-process products, products already in the market and on the process itself. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing risk analyses for particular products and businesses.

Learning Objectives:

The course offers methodologies and techniques on:

Areas Covered in the seminar:

This course will focus on conducting the risk assessment and will include the following topics:

Who will benefit:

This course was developed for those involved in the manufacture of pharmaceutical and biologic products, components, and packaging materials. The course will be especially useful for personnel responsible for:

Instructor Profile:
Frank Settineri, is the founder and President of Veracorp LLC, a consulting firm that specializes in providing pharmaceutical, biotech, medical device and startup companies with the essential advice they need to keep their businesses running efficiently and within regulatory guidelines. With over 30 years of pharmaceutical business, manufacturing and laboratory experience he is an authority on FDA Warning Letters and 483s, GMP compliance, validation planning, outsourcing, microbiology, sterile and non-sterile manufacturing issues. He learned from the best mentors and brings a unique over site to the industry that has made and saved millions for his clients.

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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 only 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."
For substitution, please email editor@complianceonline.com or call +1-650-620-3937.

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Training Options Training Duration = 90 Min
$349.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$600.00 Get Training CD Only
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