Writing, Organizing, and Maintaining Effective SOPs - Complying with FDA Inspections
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 493. 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 downright impossible. Worse, this often leads to many regulatory errors that first come to light during a FDA audit.
Virtually every FDA inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues.This webinar 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.
Course Objectives:
This webinar will instruct the participant on 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. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
Course Outline:
• SOPs and their relation to the regulations
• SOPs as part of the company's regulatory infrastructure
• SOP on SOPs and how to ensure conciseness, consistency and ease of use
• Risk Based approach on SOP Best Practices for creation and maintenance
• Training on SOPs
• Tools for SOP tracking and when is validation required
• What the FDA 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
• Consultants
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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