Objectionable Microorganisms in Biopharmaceutical Production – Risk Mitigation

Objectionable microorganisms associated with a medical device or pharmaceutical product can cause a serious illness to a patient. By testing and identifying these microorganisms 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
• Consultants