Auditing for Microbiological Aspect of Pharmaceutical and Biopharmaceutical Manufacturing
Duration: 60 Minutes
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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.
08/10/2018 10:00 AM08/10/2018 04:00 PMTraining Topic: Auditing for Microbiological Aspect of Pharmaceutical and Biopharmaceutical ManufacturingInstructor: Carl Patterson
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
Who will Benefit
Personnel involved with observing aseptic processing operations
Quality assurance personnel
Quality control personnel
Quality system auditors
Regulatory and compliance management
All personnel who work for pharmaceutical manufacturing and contract manufacturing organizations where microbiological aspects are monitored and reported