Conference Description:

OVERVIEW
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.

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.

AREAS COVERED
• 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

LEARNING OBJECTIVES
• 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

WHO WILL BENEFIT
All personnel who work for pharmaceutical manufacturing and contract manufacturing organizations where microbiological aspects are monitored and reported.
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