Writing Effective SOPs for FDA and CLIA Regulated Companies
Duration : 90 Minutes
Angela Bazigos,
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PriceWaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compl Read more
Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 42. Yet there is no guidance on how to write, organize and maintain SOPs. Consequently, SOPs are frequently written in a way that makes compliance difficult or seemingly impossible. This often leads to regulatory errors that come to light during
Course Objectives:
This course will show you how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. You will also gain a strategic view of how SOPs help
Course Outline:
• SOPs and their relation to the regulations
• SOPs as part of the company’s regulatory infrastructure
• Best Practices for writing SOPs to ensure conciseness, efficiency
• Training on SOPs
• Tools for tracking SOPs life-cycle and when validation is required
• What an inspector looks for in SOPs during an inspection
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• CEOs
• Regulatory VPs / Quality VPs / IT VPs
• Regulatory Affairs Professionals
• Quality Managers
• Quality Engineers
• Small Business Owners
• GxP Personnel
• Consultants
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
