Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

Duration: 60 Minutes
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.
Regulations Pertaining to Objectionable Microorganism
Instructor: Carl Patterson
Product ID: 505540
Objectives of the Presentation
  • 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.

Areas Covered
  • 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
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
Topic Background
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.
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Recorded Session for one participant
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Carl Patterson, M.S. has completed twelve plus years in the biotechnology, pharmaceutical manufacturing and quality fields. He completed his Bachelor's of Science in Microbiology from the University of Texas. Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master's of Science in Biomedical Quality Systems from SDSU. Through the years, has worked with several companies in regards to aseptic processing and has helped to insure the expectations, related to aseptic processing, have been met.
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