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    Oct 20, 2021

    Live Webinar- "Writing Effective sops for FDA and CLIA Regulated Companie"

    in Webinars

    Live Webinar: Writing Effective sops for FDA and CLIA Regulated Companies When: Friday November 5, 2021 - 03:00 PM Duration: 60 Minutes.

    Register Now


    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 a FDA audit. Every FDA and CLIA inspection starts with a review of SOPs. Thirty to forty percent (30%-40%) of adverse inspection issues are a result of poorly written SOPs. 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 streamline operations and create efficiencies, while ensuring regulatory compliance.


    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 and ease of use Risk Based approach for writing SOPs

    Training on SOPs

    Tools for tracking SOPs life-cycle and when validation is required

    What an inspector looks for in SOPs during an inspection


    Register soon because space is limited.

    We hope you’re able to join us!


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