Objectionable Microorganisms: Considering the Risk

Speaker

Instructor: Frank Settineri
Product ID: 701313
Training Level: Intermediate to Advance

Location
  • Duration: 90 Min
This Objectionable Microorganism training will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.
RECORDED TRAINING

 

$500.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

FACT: Due to increased scrutiny by the FDA and other regulatory agencies, companies must now determine how to reduce the risk if they find objectionable microorganisms. This webinar will provide insight into reducing this risk.

GMPs require that products be free of objectionable microorganisms and it is incumbent upon manufacturers to ensure their products meet these requirements. But just what is an objectionable microorganism? This webinar will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

Areas Covered in the seminar:

  • What is an Objectionable Microbe?
  • Pathogens vs. Objectionables.
  • Just how objectionable is it?
  • Consider the risk.
  • Performing a risk assessment.
  • Example

Who will benefit:

  • Quality system auditors
  • Senior Management responsible for making final decisions
  • QA directors and managers
  • Information Technology managers and personnel
  • Microbiology analysts and technicians
  • Consultants
  • Regulatory and Compliance Management

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. His accomplishments in science (setting up and running laboratories), compliance (auditing, validation, and outsourcing) and business (building a start-up pharmaceutical company and its infrastructure) endow him with a unique oversight of the industry that has benefited his clients, including major pharmaceuticals, start ups, laboratories and generic companies.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

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