SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations 2019 is a seminar focused on what SOPs are, what they are used for, when they are required, how to write them effectively.
Topics
- Legal requirements for SOP creation and maintenance
- Regulatory requirements for SOPs
- Formats and essential components of SOPs
- Types of SOPs
- SOP training and implementation
- How to effectively write an SOP to ensure compliance
- Deviations from and changes to SOPs
Who should Attend
- Managers
- Directors
- Auditors
- Supervisors
- Clinical investigators, site management and contracting personnel
- Regulatory operations
- Project managers
- Clinical operations
- Medical writers
- Data management
- Anyone required to create SOPs for their job function in a regulated industry
- Compliance officers
