Objectionable Microorganisms in Pharmaceutical Manufacturing
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.
To date, Carl has now
garnered over two decades’ worth of extensive hands-on expertise.
Currently, he is the Chief Consultant of his very own consultant
business called aseptic-process.net, where he specializes in the aseptic
processing of pharmaceutical products in the pharmaceutical
manufacturing sector. Recently, he is in the process of creating
webinars so he can share pertinent information about pharmaceutical
manufacturing from a microbiological perspective.
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.
Objectionable microorganisms are considered if discovered, harmful to the patient. By identifying and controlling these microorganisms, then 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
- 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
Course Level - Intermediate
Who Should Attend
Employees, Supervisors, and Managers involved in compounding drug products. Quality personnel involved with reviewing procedures, batch records, and results associated with aseptically compounding drug products.