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Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
- International regulation (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
Overview of the webinar
The session 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 should attend?
- Quality Control Personnel
- Quality Assurance Personnel
- Manufacturing Personnel
- Auditors
Why should you attend?
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.
Faculty - Mr.Carl Patterson
Carl Patterson, M.S. has completed twelve plus years in the biotechnology, pharmaceutical manufacturing and quality fields. He completed his Bachelor's of Science in Microbiology from the University of Texas. Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master's of Science in Biomedical Quality Systems from SDSU. Through the years, has worked with several companies in regards to aseptic processing and has helped to insure the expectations, related to aseptic processing, have been met.