The seminar 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.
- Provide background information on what microbiological aspects to audit.
- What international regulations should be referenced.
- ISO classification of rooms and how it should be applied
- 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
- Product bioburden and why bioburden is important.
- Quality Departments
- Manufacturing Departments
- Engineering Departments
- Regulatory Departments
- Contract Manufacturing Organizations