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. Virtually every FDA inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues. 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 an FDA audit.
Join this session, where expert speaker Angela Bazigos will show you how to write, organize, and maintain SOPs and train personnel to ensure compliance in a way that is concise, reproducible and easy to follow. The session will begin with a strategic view of SOPs and how SOPs can help streamline operations in addition to ensuring regulatory compliance in an organization. Angela will provide an explanation of how to create SOPs based on regulatory requirements. She will also discuss the best practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection.
Who Should Attend
CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA, MIS Director....
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