Topics
- SOPs as part of the company`s regulatory infrastructure
- SOPs and their relation to the regulations
- Risk Based approach on SOP Best Practices for creation and maintenance
- SOP on SOPs and how to ensure conciseness, consistency and ease of use
- Tools for SOP tracking and when is validation required
- Training on SOPs
- What the FDA looks for in SOPs during an inspection
Who should Attend
Compliance, Regulatory Affairs, Documentation, QA / QC, Product/ Project Managers, Validation, IT/IS Director and Manager.
