Poorly written SOPs can negatively impact efficiency and quality. They can even lead to recalls.
This two-day intensive workshop is your secret weapon for avoiding 483 and warning letter citations of “inadequate SOPs.” It will ensure your SOPs are clearly written, easy to understand and follow, and keep you compliant.
Susanne Manz, a consultant with an extensive background in quality and compliance, will give you practical tools and tips on how to write clear, unambiguous and flexible SOPs that are easy for your employees to read and follow consistently.
The result? Your quality management system (QMS) will be more efficient and effective.
In the workshop, Manz will provide specific examples and hands-on small-group exercises to teach you how to make certain your personnel can consistently and accurately follow your SOPs to achieve quality outcomes and reliable results.
- What FDA investigators are looking for in your procedures
- How to outline and format your SOPs
- How to understand your audience
- Correct use of terms, such as “shall,” “should,” “may,” “can,” and “guidance”
- How to use process maps, pictures and diagrams to improve clarity
- How to mistake-proof your SOPs
- How to ensure good documentation practices
- How to prepare for an FDA inspection
Your SOPs are likely the first thing an FDA investigator will ask for. Make sure yours communicate that your processes are complete, accurate and followed consistently. Join us by registering today.
Who Will Benefit:
- Quality systems specialists
- Document control specialists
- CAPA specialists and managers
- Regulatory and compliance specialists
- Internal auditors and managers
- Training specialists and managers
- Subject matter experts and process owners who write procedures