Online Webinar 2019 - Live Webinar Auditing for Microbiological Aspects in Pharmaceutical and Biopharmaceutical Manufacturing

Overview
Microorganisms can be found in any aspect of pharmaceutical and, especially, biopharmaceutical manufacturing. Understanding where to look for microorganism and how these are introduced into your process will provide success when being reviewed by an auditor. It is not enough to identify microorganism in your process, but to understand, how, where, when, and why the microbes are in your process. These are questions regulatory auditors will ask when your facility is being inspected.
Session Highlights
International regulations (ISO)
Federal regulation (FDA, USP)
Room classifications and how applied to manufacturing
Auditing company environmental programs for effectiveness
Reviewing of documents in relation to microbial aspects
Sources of common microorganisms
Identify root causes for many microbiological excursions
Why Should you Attend
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.
Who Will Benefit
This training webinar has been designed for the following personnel in pharmaceutical, biopharmaceutical companies:
Quality assurance personnel
Quality control personnel
Microbiology professionals
Validation
Manufacturing
Quality system auditors
Warehouse managers
Facilities/maintenance
Regulatory and compliance management
Instructor Profile
Carl Patterson
Carl Patterson
QA Team Lead, Bachem
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.