The webinar 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.
The microbial aspect of pharmaceutical/biopharmaceutical manufacturing is a key component of the overall manufacturing process. Understanding this component is vital in ensuring a pharmaceutical product meets the expectations of a regulatory agency. If this component of the manufacturing process is not well understood, consequences to be harmful to the patient and subsequently the company producing the product.
All personnel who work for pharmaceutical manufacturing and contract manufacturing organizations where microbiological aspects are monitored and reported.
Carl Pattersonis 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 theU.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.
Carl holds various degrees and certifications, includingan 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.View all trainings by this speaker