SOP and FDA Compliance by Angela Bazigos
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Website https://compliance2go.com/product/?pid=CP2014-420 |
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Category Medical Device
Deadline: February 10, 2015 | Date: February 11, 2015
Venue/Country: Online, U.S.A
Updated: 2015-01-26 16:05:00 (GMT+9)
Call For Papers - CFP
DESCRIPTIONStandard 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 and FDA audit.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.Areas Covered in the Session:SOPs and their relation to the regulationsSOPs as part of the company's regulatory infrastructureSOP 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 SOPsTools for SOP tracking and when is validation requiredWhat the FDA looks for in SOPs during an inspectionWho will benefit: Anyone who would be involved in Anyone that creates / maintains SOPsVPDirector, Manager of any dept that writes SOPs or performs trainingQA / QCWebinar Includes:Q/A Session with the Expert to ask your questionCopy of PowerPoint slides (PDF print only)90 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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