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Microbiology Quality Control 2022 - Objectionable Microorganisms in Biopharmaceutical Production – Identification and Risk Mitigation



VenueOnline, Online Online

KeywordsMicrobiology; FDA Inspections; Compliance


Topics/Call fo Papers

Objectionable Microorganisms in Biopharmaceutical Production – Identification and Risk Mitigation
Product Id : FDB3261
Category : Clinical & Laboratory, Food, Drugs & Biologics, Quality
Presenter : Carl Patterson
Scheduled On : March 03 2022 1:00 pm
US/Canada (Eastern Time - ET)
Duration : 60 Minutes
Objectionable microorganisms associated with a medical device or pharmaceutical product can cause a serious illness to a patient. By testing and identifying these mircoorganisms early in the manufacturing processes, controls can be put into place to prevent harm to the patients.
Objectionable microorganisms are considered, if discovered, harmful to the patients. By identifying and controlling these microorganisms, and putting the appropriate controls in place early in the pharmaceutical manufacturing or medical device manufacturing processes, problems in the patients can be prevented. This webinar will review the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place. By knowing, where, when, why and how objectionable microorganisms exist, harmful consequences to the patients can be prevented.
Areas Covered in the Session :
Regulations pertaining to objectionable microorganisms
Knowing what microorganisms are considered objectionable
The importance of knowing what microorganism are there in your product
Identifying objectionable microorganisms
Sources of microorganisms in pharmaceutical manufacturing facility
How to determine if you have an objectionable microorganism
Tests to determine objectionable microorganisms
Methods to control and reduce the amount of objectionable microorganisms
Who Should Attend:
Quality Assurance Departments
Quality Control Departments
Microbiology Analysts and Technicians
Regulatory Affairs Departments
Manufacturing Departments
Engineering Departments
Operations Departments
Production Departments
Logistics Departments

Last modified: 2022-02-16 19:05:46