SOP and FDA Compliance 2014

Topics

• SOPs (Standard Operating Procedures) 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

• VPs
• Anyone that creates / maintains SOPs
• QA / QC
• Directors, Managers of any dept that writes SOPs or performs training
• Regulatory Affairs Titles