Auditing for Microbiological Aspects of Pharmaceutical Manufacturing
01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and Live Webinar
"Listen from Carl Patterson "Creating a QC Lab function where none had existed previously (Bioserv)"
Microbiological aspects of manufacturing
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.
• 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
• QA personnel,
• QC personnel,
• Manufacturing personnel,
• Auditing personnel
Industries who can attend
This 60 minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.