Category Archives: Quality

25Apr/17
Supply-Chain-Squares (3)

Quality Management Across Your Global Supply Chain

By: Sandra K. Rodriguez, Market Analyst

Learn How to Take Back Control of Quality – On Demand Webinar

Daniel Matlis, President of Axendia and Ashley Wentworth, Vaulty Quality Strategy at Veeva Systems presented thought leadership on this topic in an FDANews Webinar on March 22, 2017.  Specifically, they discussed the importance of quality management across the global supply chain in FDA Regulated environments.  Topics of discussion included:

  • Globalization and Outsourcing Trends in Life-Sciences
  • Regulatory Expectations for Outsourcing
  • Quality Metrics and Data Integrity
  • The Paradigm Shift in Quality Management
  • How to Source Quality Data and Benefits of a Cloud QMS
  • Modernizing Quality Management
  • Moving to Predictive Quality Organizations

Globalization and outsourcing has created unique opportunities and demanding challenges for the industry and regulators alike.  Read More.

The webinar is also available on demand.

08Mar/17
Supply-Chain-Squares (3)

QUALITY MANAGEMENT ACROSS YOUR GLOBAL SUPPLY CHAIN

How Can the Cloud Help with Data Integrity and Quality Issues Across your Global Supply Chain?

REGISTER TODAY
Date: MARCH 22, 2017
Time: 1:30 PM EST

All your data used to be close by — under your control — and easily monitored. Now, as you outsource more and more, your direct control on quality is weakened. By using a cloud based solution you can take back control. You can monitor your quality metrics in real time wherever they’re being generated and head off issues way before an FDA investigator even sets foot in your facility.

In this session, you will learn how to:

  • Drive enhanced product quality at reduced costs and risks while assuring compliance with all applicable regulatory requirements
  • Leverage modern quality systems to improve visibility, control and collaboration across your supply chain
  • Shift from just documents to also including data to support quality metrics across global and externalized supply chain networks
  • Reduce inspection frequency and risk through modern quality systems and real-time quality metrics
  • Reduce data integrity risks before they occur
  • Sleep better at night!

Attend the Webinar – Sponsored by Veeva

28Feb/17
online-survey

Medical Device Industry Survey

Do Medical Device Manufacturers Have a Culture of Innovation and Quality?

Help Us Find Out!

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  • Are you Manufacturing Innovative Medical Devices?
  • Is your company building a culture of innovation and quality?
  • How do your actions compare with your peers?

To find answers to these and other questions of interest to the medical device community, we are asking for your participation in this global research study.

The survey also seeks to understand:

  • What practical steps medical manufacturers are taking to evolve their quality practices
  • The role of automation in supporting best practices for compliance and quality
  • How manufacturers are incorporating smart, connected sensors across their product portfolio
  • The impact of the Internet of Things (IoT) on medical device manufacturers

As a survey participant, you may register to receive a complimentary copy of the research report.  Please Note: All individuals responses will be kept strictly confidential and only aggregated data will be used.

Follow this link to begin the survey.

This primary research is being conducted by Axendia and sponsored by PTC.

01Feb/17
FDA_small

Hear Directly from FDA: Driving a Culture of Quality for Devicemakers

Webinar Announcement

FDA and Industry Find Common Ground Driving a Culture of Quality

DATE: March 1, 2017
TIME: 1:30PM Eastern

Industry leaders and regulators are working on the Case for Quality (CfQ) initiative to shift their focus from compliance to quality by giving greater focus and emphasis to critical-to-quality practices throughout the lifecycle of the product.

Would you like to reduce your regulatory burden? Pay dividends in enhanced and predictable product performance? Streamline processes resulting in operational efficiencies? Reduce waste driving to lower costs and improved profitability?

CFQ_Webinar1

Join Sean Boyd — Deputy Director for Regulatory Affairs, CDRH’s Office of Compliance — Francisco (Cisco) Vicenty — Program Manager (Acting), Case for Quality, FDA — and Daniel R. Matlis — President, Axendia — on March 1st when they’ll discuss the effect the CfQ will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient.

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