Medical Device Process Validation: A Virtual Conference - January 29-30, 2019

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MedTech Intelligence

Volume 10 Issue No. 45

Business Analysis Combination Products Market Access Operations Product Development Quality/Regulatory
 
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TransPerfectThe Cure for the MDR/IVDR Labeling & Content Headache

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The Diagnosis: MDR/IVDR will generate more content, updates, translation, and publishing with increased regulatory scrutiny; impossible to support with traditional document-based systems (InDesign, Word, Frame). The Treatment: Structured content (XML/CCMS) + translation process automation (with AI-Assist™) is a modular solution for a division or entire enterprise. New Rapid Prototyping Program provides measurable proof of concept.

 

MedTech IntlligenceMedical Device Process Validation

A Virtual Conference | January 29 - 30, 2019

Deficiencies in process validation and other aspects of production and process control earn more FDA enforcement actions than any other quality function except CAPA. This two-day workshop addresses key issues in process validation, including risk-based determination of processes to be validated, FDA and 13485:2016 requirements, key process validation elements and best practices, statistical and other tools, maintaining the validated state, and documentation.

Attend virtually from your location!

Upcoming Events & Webinars

Nov. 2018November 27-28, 2018 - EU MDR Implementation Strategies Workshop
Washington, DC

JanuaryJanuary 23-24, 2019 - Advanced CAPA and Root Cause Analysis Workshop for Medical Device Companies
Washington, DC

JanuaryJanuary 29-30, 2019 - Medical Device Process Validation
A Virtual Conference

February 5-6, 2019 - EU MDR Remediation Strategy
Washington, DC

February 6-7, 2019 - EU MDR Clinical & Postmarket Surveillance Strategies
Washington, DC

March 5-6, 2019 - Med Tech Import/Export
Washington, DC

March 7-8, 2019 - EU MDR Supply Chain & Economic Operators
Washington, DC

April 11-12, 2019 - EU IVDR Implementation
Washington, DC

May 7-8, 2019 - Medical Device Cybersecurity: Legacy Device Remediation, Compensating Controls, & End-of-Life
Cambridge, MA

May 21-22, 2019 - Medical Device Recalls: Current Topics & New Initiatives
Washington, DC

May 23-24, 2019 - EU MDR Labeling, IFU, UDI, & Eudamed
Washington, DC

June, 2019 - Global Regulatory Strategy
Washington, DC

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