Category Archives: Supply Chain

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

27May/16
future-technology-3d-printer

3D Printing is the New Supply Chain Disruptor

Navy Officials: 3D Printing To Impact Future Fleet with ‘On Demand’ Manufacturing Capability

By John Joyce, NSWC Dahlgren Division Corporate Communications

DAHLGREN, Va. – Is it possible to produce parts and equipment from scratch for Sailors – aboard ships and on demand?

Can the Navy rush deliver parts and high-tech gear such as customized unmanned systems, avionics components, and improvised explosive device detectors to its warfighters?

“Yes we can,” say Navy officials and when Additive Manufacturing – also known as 3D Printing – fully hits the Fleet, Sailors could receive their orders within a substantially reduced time frame.

Remarkably, Sailors and Marines are already inventing new products, expanding the realm of possibilities made real by 3D printing while saving time, resources, and money. Continue reading

11Aug/15
Supply-Chain-Squares (3)

FDA Delayed Enforcement of DQSA Requirements – Part II

By David Lennard, Vice President and Ellyn McMullin, Research Associate, Axendia

Delayed Enforcement Provides Opportunity to Develop Complimentary Systems

The FDA’s delayed enforcement of DQSA requirements until May 1, 2015 and its second enforcement delay for dispensers until November 1, 2015, may be an unexpected “gift” that gives some companies not only more time to implement data sharing agreements but also the opportunity to reap the business rewards of data mapping and visibility into their own supply chain at the same time.

In the initial article in this series, we discussed how organizations can use DQSA data to benefit their business and their relationships with trading partners.

In this article we cover a key provision of DQSA:  the identification, control and handling of suspect and illegitimate product.  Continue reading

14Jul/15
FDALogo

FDA DELAYED ENFORCEMENT OF DQSA REQUIREMENTS


Delayed Enforcement Provides a Business Opportunity

By David Lennard, Vice President and Ellyn McMullin, Research Associate, Axendia 

On July 1st, FDA  published guidance stating that: “FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving the product tracing information, as required by section 582(d)(1)(A)(i) of the FD&C Act.”

Last December, FDA published guidance informing industry that it did not intend to Supply-Chain-Squares (3)take action against manufacturers, wholesale distributors, or repackagers who did not, prior to May 1, 2015, provide or capture the product tracing information required by the new Drug Quality and Security Act (DQSA).

Continue reading