Failure to Follow established SOPs” is the most common observation from regulatory bodies. Translated this means the Standard Operating Procedures (SOPs) put into place were not adequate for personnel to follow as well as record the information needed. Poorly written procedures make it difficult for your employees to understand and consistently follow procedures. Once these SOPs are put into place it is difficult to rectify the problem, putting the work and thoughtfulness up front to make sure your procedures are concise and understandable will save your business trouble when an auditor arrives for an inspection. Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System.
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 well documented and justifiable results. This webinar will help you to write clear, concise, and flexible SOPs. You will learn techniques for creating easy to read and clear SOPs your employees can easily follow. Well written SOPs ensure that your employees understand and consistently follow your manufacturing processes.
Agenda
- Lessons Learned from 483s and Warning Letters
- FDA Expectations for SOPs
- Common Problems and Mistakes
- How to Outline and Format your SOPs
- Using Process Maps to Make Procedures Clear
- Use of Visual Aids
- Ensuring Adequate Training to your SOPs
Speakers
Carl Patterson,
Who Should Attend
- Pharma & drug manufacturing personnel
- Quality Control personnel
- Quality Assurance personnel
- Personnel involved with medical device manufacturing
- Personnel involved with training and development
- Document Control Personnel
