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.
Objectives of the Presentation
- Provide background information on what microbiological aspects to audit for
- What international regulations should be referenced
- ISO classification of rooms and how it should be applied
- Product bioburden and why bioburden is important.
- Validation and qualification of bioburden and manufacturing suites.
- Key sources of microorganisms and why this is important
- What the source means in terms of root cause
Why Should you Attend
The risk of non-compliance related to microbiological causes is too great, in terms of fines, potential law suits, loss of consumer confidence and ultimately, the bottom line. This means that biopharmaceutical manufacturers must prove that their facilities and products are free from contamination.
This webinar is designed to help organizations understand that preventing microbial contamination is the responsibility of everyone in the organization, and that everyone must play a part in it. Attendees will learn how to create a robust inspection program that includes auditing for potential sources of microbial contamination.
- 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
QA Specialist ,
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.
Who will Benefit
- Personnel involved with observing aseptic processing operations
- Quality assurance personnel
- Quality control personnel
- Microbiology professionals
- Quality system auditors
- Warehouse managers
- Regulatory and compliance management
- All personnel who work for pharmaceutical manufacturing and contract manufacturing organizations where microbiological aspects are monitored and reported