Auditing for Microbiological Aspects 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.
The seminar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. There are international and federal regulations that describe what aspects should be considered during manufacturing. This webinar will go into detail on those regulations and how they apply to pharmaceutical and biopharmaceutical manufacturing.
- Provide background information on what microbiological aspects to auditing
- What international regulations should be referenced
- ISO classification of rooms and how it should be applied
- Validation and qualification of bioburden and manufacturing suites
- Key sources of microorganisms and why this is important
- What the source means in terms of the root cause
- Product bioburden and why bioburden is important
Course Level - Intermediate
Who Should Attend
- Quality Assurance
- Quality Control
- All personnel who work for pharmaceutical manufacturing and contract manufacturing organizations where microbiological aspects are monitored and reported