Overview:
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Well written SOPs send a message to the FDA and Notified Bodies that
your QMS is complete, accurate, and followed. More importantly, well
written SOPs ensure that your personnel can consistently and accurately
follow your processes resulting in correct outcomes and quality work.
This webinar will help you to write clear, unambiguous, and flexible
SOPs. You will learn techniques for creating easy to read, clear, and
concise SOPs that your employees can easily follow. Well written SOPs
ensure that your employees understand and consistently follow processes.
Well written SOPs send a message that your QMS is complete, accurate,
and followed.
Why you should Attend:
"Inadequate SOP" observations still rank among the most frequently cited
483 and Warning Letter observations. SOPs are one of the first things
an auditor/ investigator will review during and inspection. Most
importantly, poorly written procedures make it difficult for your
employees to understand and consistently follow procedures. This can
lead to disastrous consequences including quality problems and even
recalls. Poorly written SOPs can and do impact your business.
Areas Covered in the Session:
- FDA Expectations for SOPs
- Lessons Learned from 483s and Warning Letters
- Common Problems and Mistakes
- How to Structure your QMS and SOPs
- How to Outline and Format your SOPs
- Using Process Maps to Make Procedures Clear
- Using Diagrams and Visuals
- Maintaining and Controlling SOPs
- Ensuring Adequate Training to your SOPs
- Best Practices
Who Will Benefit:
- Quality Systems Specialists
- Document Control Specialists
- Quality and Compliance Specialists
- Internal Auditors and Managers
- Training Specialists
- CAPA Specialists
- Quality/Compliance Managers or Directors for Medical Device Companies
- General Managers Wanting to learn how to Understand Quality System Requirements
- Subject Matter Experts