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I got it!

Mr John E Lincoln

Researcher

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company. John, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles and workshops worldwide.

John E spoke at

Medical Device Software - do you understand how software is regulated? AtoZ Compliance Mar 2016
Device Changes and the 510(k) - By AtoZ Compliance. AtoZ Compliance Mar 2016
Root Cause Analysis - The Heart of a Successful CAPA Program. AtoZ Compliance Feb 2016
Webinar on Robust Verification and Validation Compliance Trai... Feb 2016
Webinar on U.S. FDA's Strategic Priorities - 2016 and Beyond Compliance Trai... Jan 2016
Webinar On U.S. FDA Project Management FutureCorp Cons... Oct 2015
Webinar On Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485 FutureCorp Cons... Sep 2015
Webinar On 9 Required Elements of Design Control System FutureCorp Cons... Jul 2015
Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 R... NetZealous Jun 2015
Webinar On Robust Corrective And Preventive Action FutureCorp Cons... Jun 2015
DHF, DMR, DHR, Technical File and Design Dossier NetZealous May 2015
Webinar Medical Device Changes and the 510(k) Compliance Trai... Mar 2015
Webinar On Key Regulatory Documents Compliance Trai... Feb 2015
Webinar On Robust Verification and Validation Compliance Trai... Feb 2015
Webinar On U.S. FDA's Strategic Priorities - 2015 and Beyond Compliance Trai... Jan 2015
Webinar On Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485 Compliance Trai... Oct 2014
Webinar On Medical Device Changes and the 510(k) Compliance Trai... Sep 2014
Webinar On Robust Corrective And Preventive Action (CAPA) Compliance Trai... Aug 2014
Webinar on Prepare for Your cGMP Inspection Compliance Trai... May 2014
Webinar On - The FDA's New Guidance on Wireless Devices Compliance Trai... Mar 2014
Webinar On - Master Validation Planning To Meet U.S. FDA cGMP, ISO 134... Compliance Trai... Mar 2014
Webinar On - Key Regulatory Documents: Design History File (DHF), Devi... Compliance Trai... Feb 2014
Seminar on GlobalComplianc... Sep 2013
Setting Up and Running a Tougher Supplier Audit GlobalComplianc... Jun 2013
Device Changes, FDA Changes, and the 510(k) GlobalComplianc... May 2013
CAPA, Failure Investigation GlobalComplianc... May 2013
Verification vs. Validation GlobalComplianc... May 2013
Software Verification and Validation Planning GlobalComplianc... Apr 2013
Meet the U.S. FDA's Tougher Requirement GlobalComplianc... Mar 2013
Design History Files (DHF), Device Master Records GlobalComplianc... Mar 2013
Product Hazard Analysis GlobalComplianc... Jan 2013
2-day In-person Seminar on Verification/Validation GlobalComplianc... Jan 2013

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