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Quality Nightmares #37: The Matador

29 March 2018

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MasterControl Sponsors Free RAPS Webinar: Preparing for Medical Device Single Audit Program (MDSAP) Audit Success

15 March 2018

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How an EQMS can make the transition to MDR seamless

14 December 2017

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NEWS - UL and MasterControl Provide Free Webinar “The FDA Just Left – Now What?”


SALT LAKE CITY, UT, USA - February 16, 2016 - MasterControl, a leading global provider of enterprise quality management systems (EQMS) and quality consulting services, and Underwriters Laboratories (UL) LLC, a global safety consulting and certification company, will host the second installment of a complimentary webinar series on FDA inspections.

Live Webinar: The FDA Just Left – Now What?

February 17, 2016

11:00 a.m. – 12:00 p.m. EST

Register Now - http://www.uleduneering.com/news-events/webinars/february-17-fda-just-left-now-what/ to participate or receive a link for the webinar soon after the showing.

Knowing what to do immediately after an FDA inspection can be just as difficult – and is just as critical – as knowing what to do before and during the inspection. Even when the inspection ends, there is still work to do. Failure to meet the investigator’s requirements can have devastating consequences. “The FDA Just Left – Now What?” webinar will give detailed insight into what to do after an FDA investigator has completed an inspection, issued a Form 483, discussed response requirements and left your facility.

MasterControl’s Walt Murray and Underwriters Laboratories’ Linda Chatwin will take an in-depth look at what steps to take at the conclusion of an inspection, including:

  • How to address major FDA findings
  • How to manage appropriate response types
  • How to apply CAPAs to the findings
  • Why to update the FDA on your progress

Murray has more than 25 years’ experience in quality and regulations and Chatwin has more than 30 years’ experience working with regulated medical products. Join them to learn what the FDA expects after an inspection.

Walt Murray, Director of Quality and Compliance Consulting Services, MasterControl Inc.

Walt Murray is a quality management and regulatory affairs professional with more than 32 years of experience working with internationally recognized, highly regulated companies, including Aventis-Pasteur, Merck, Pfizer, Stryker, USANA and Del Monte Foods. A Six Sigma Black Belt, Murray is certified in quality and environmental systems auditing (AQS Systems), critical-thinking skills and process control. He also has extensive training and consulting expertise in quality event/CAPA management, risk management, supplier control and audit management.

Having personally performed more than 200 third-party audits, for a variety of Fortune 500 life sciences companies, Murray has hosted investigational and systems audits by the FDA, Therapeutic Goods Administration (TGA), Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Canada.

Linda Chatwin, Esq., RAC, Business Manager and Regulatory Affairs Consultant - Medical Regulatory Advisory Services, Underwriters Laboratories

Linda Chatwin has been involved with regulated medical products for over 30 years. Her expertise includes navigating the global regulatory maze required to bring products to market, achieved through years of watching regulations evolve and change. She has obtained product approvals for a wide range of products and remains involved in changing requirements for medical devices worldwide. Linda has navigated many FDA inspections, and has negotiated favorable outcomes with FDA. Currently, she assists clients with regulatory issues and challenges, including implementation of UDI processes, performing mock audits, in-depth training on regulatory requirements and consulting on quality system development and improvement.

About MasterControl

MasterControl Inc. is a committed team of quality, regulatory and software experts who work to empower regulated companies to get their products to market faster. MasterControl's quality management software solutions reduce overall costs, increase efficiency and accelerate compliance, creating a significant competitive advantage for customers. Drawing upon unparalleled industry experience, MasterControl offers a suite of seamlessly integrated and scalable software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management and much more. MasterControl's complete quality management solution is designed for easy implementation, validation and use, continually improving on the promise of Compliance Accelerated.

For more information about MasterControl, visit www.mastercontrol.com or call 1.800.825.9117 (U.S.); +44 (0) 1256 325 949 (Europe); +81 (03) 5422 6665 (Japan); or +61 (3) 9717 9727 (Australia).