Process Validation - overview of Why and How
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Website https://compliance2go.com/product/?pid=CP2014-418 |
Edit Freely
Category Medical Device
Deadline: March 17, 2015 | Date: March 17, 2015
Venue/Country: Online, U.S.A
Updated: 2015-02-27 17:34:53 (GMT+9)
Call For Papers - CFP
DESCRIPTIONIn this presentation will cover the requirements for process validation from FDA cGMP and ISO 13485. It will also cover when process validation and revalidation are necessary or desirable. An outline of equipment qualification necessary for some equipment and equipment in some processes will be given. An overview of what is required for process validation will be covered. Guidelines will be provided for attendees as well as information about where to get additional information. Why you should attend:Do you need to understand the fundamentals of Process Validation? If so this presentation will cover the FDA and ISO requirements and give an overview of how to meet them. Process validation is a requirement but knowing when to validate or revalidate a process is essential. If you do not validate you risk enforcement actions such as fines or recalls, but too much validation is costly in both time and money. This presentation will cover the basics of this important topic for those who are new to quality or new to process validation. Areas Covered In the Seminar:What is Process ValidationWhy is Process Validation necessaryProcess Validation GuidelinesHow to determine if a process requires ValidationWhat processes should be validatedProcess Validation OutlineIQ ? Installation QualificationOQ ? Operational QualificationPQ ? Performance QualificationProcess MonitoringWho will benefit:This webinar will provide valuable assistance to all personnel in: Quality EngineeringManufacturing engineersInternal auditing Compliance Others in Quality Quality Managers new to medical devices or process validationOperations/Manufacturing Managers new to medical devices or process validationMedical device consultants new to process validationFree documentsProcess Validation Decision Tree ChartProcess Validation guidelinesWebinar Includes:Q/A Session with the Expert to ask your questionCopy of PowerPoint slides (PDF print only)60 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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