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Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

4324
Duration : 60 Minutes

Carl Patterson, MS, SSGB, SSBB,

Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However Read more


This webinar will review the regulations pertaining to objectionable microorganisms, testing and identifying objectionable microorganisms, and putting appropriate controls into place to prevent harming patients.

Course Objectives:

• 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

Why Should You Attend:

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.

Course Outline:

• Definition of objectionable microorganisms
• Regulations pertaining to objectionable microorganisms
• Identifying objectionable microorganisms
• Tests to determine objectionable microorganisms
• Sources of objectionable microorganisms
• Actions to reduce objectionable microorganism

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Quality Assurance
• Quality Control
• Production
• Logistics
• Manufacturing
• Quality system auditors
• QA directors and managers
• Microbiology analysts and technicians
• Consultants
• Regulatory and Compliance Management

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production


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