Writing SOPs to Enhance Understanding and Compliance
Almost every paragraph of the Quality System Regulation states that manufacturers shall “establish” procedures. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs that accomplish that objective. You will learn techniques for creating concise and easy-to-read SOPs that your employees can understand and will follow. Well-written SOPs result in more consistent process output and quality results.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. Learning ObjectivesOverview of the RegulationsHow to “establish” proceduresLessons Learned and Common MistakesBest PracticesPreparing for an FDA InspectionFDA expectations for SOPsLessons Learned from 483s and warning lettersHow to structure your QMS and SOPsHow to outline and format your SOPsUse of Should, Shall, May, Do Not, GuidanceComplete and conciseUsing process maps to make procedures clearUsing diagrams and visualsMistake proofingMaintaining and controlling SOPsEnsuring adequate training to your SOPsWho Should AttendQuality Systems SpecialistsDocument Control SpecialistsQuality and Compliance SpecialistsInternal Auditors and ManagersTraining SpecialistsCAPA SpecialistsQuality/Compliance managers or directors for Medical Device companiesGeneral Managers wanting to learn how to understand Quality System requirementsSubject Matter Experts who write proceduresWhy Should You 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 an 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.
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Almost every paragraph of the Quality System Regulation states that manufacturers shall “establish” procedures. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs that accomplish that objective. You will learn techniques for creating concise and easy-to-read SOPs that your employees can understand and will follow. Well-written SOPs result in more consistent process output and quality results.
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.
Learning Objectives
- Overview of the Regulations
- How to “establish” procedures
- Lessons Learned and Common Mistakes
- Best Practices
- Preparing for an FDA Inspection
- FDA expectations for SOPs
- Lessons Learned from 483s and warning letters
- How to structure your QMS and SOPs
- How to outline and format your SOPs
- Use of Should, Shall, May, Do Not, Guidance
- Complete and concise
- Using process maps to make procedures clear
- Using diagrams and visuals
- Mistake proofing
- Maintaining and controlling SOPs
- Ensuring adequate training to your SOPs
Who Should Attend
- 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 who write procedures
Why Should You 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 an 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.
