Risk of Objectionable Microorganisms in Bio-Pharmaceutical Manufacturing

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and Live Webinar

"Listen from Carl Patterson "Creating a QC Lab function where none had existed previously (Bioserv)""

Objectionable microorganisms

Description

Objectionable microorganisms are considered, if discovered, harmful to the patient.  By identifying and controlling these microorganism and putting the appropriate controls place early in the pharmaceutical manufacturing or medical device manufacturing process problems in the patient 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 patient 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
•        And much, much more…

Who will Benefit

•        QA personnel, 
•        QC personnel, 
•        Manufacturing personnel, 
•        Auditing personnel

Industries who can attend

This 60 minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Carl Patterson, M.S.

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, his avid interest in all things biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse. Furthermore, Carl holds various degrees and certifications, including an M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.

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