Topics
- FDA regulations
- Review of recall data
- ICH guidelines
- FDA guidance on Aseptic Processing
- Risk assessment of the presence of microorganisms in the aseptic environment and its impact on product
- Definitions of "objectionable microorganisms"
Who should Attend
Delegates involved in Quality system auditors, Manufacturing, Microbiology analysts and technicians, QA directors and managers, Regulatory and Compliance Management and Consultants.
