22Apr/19
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FDA is Enabling Innovation and Modernization

By: Thomas O’Connor, Sr. Chemical Engineer, US FDA

FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of the Agency’s mission to protect and promote public health. FDA recognizes that continuous manufacturing is an emerging technology that can enable pharmaceutical modernization and deliver potential benefits to both industry and patients. Continuous manufacturing can improve pharmaceutical manufacturing by, for example, using an integrated process with fewer steps and shorter processing times; requiring a smaller equipment footprint; supporting an enhanced development approach (e.g., quality by design (QbD) and use of process analytical technology (PAT) and models); enabling real-time product quality monitoring; and providing flexible operation to allow scale-up, scale-down, and scale-out to accommodate changing supply demands. Continue reading

18Apr/19
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What Is Your Human Potential?

Infor 2019 Conference Event Brief

By: Eric M. Luyer, Industry Research Analyst

Last week I was inspired by the great conference  “INSPIRE” that was organized by Infor in Amsterdam, The Netherlands. The tagline for this conference was the question: “What is your Human Potential?”  The conference amazed the attendees with a series of presentations on Infor products, their potential, and responses to questions on how to best deploy lnfor’s latest technologies around new applications for various types of industries and different user-levels.

Elevating Human Potential Through Innovation in Science and Technology

It is clear that Infor has its roots in Manufacturing and Distribution as they elaborated on their capabilities in their space using the latest technologies, such as business analytics (with BIRST), artificial intelligence (with Coleman), and the challenges around digital transformation.

Register to read the full event brief.

01Apr/19
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The Value of Analytics in Healthcare

Perspectives from Key Stakeholders in the Healthcare Ecosystem

By: Daniel R. Matlis, President

Healthcare is shifting to a value-based model focused on improving the quality of patient outcomes, enhancing patient-centered care and adopting initiatives that control costs.

The transition to value-based healthcare hinges on the availability of unbiased quality and outcomes 7-Metrics-Value-Based-Care_1data. Furthermore, the integrity of these decisions depends upon the accurate and objective analysis of these data to support patient care decisions.

We interviewed the following thought leaders representing key stakeholders from the CfQ PQOA working group to gain their unique perspective on the value of analytics in value-based healthcare.

  • Stephanie Christopher, Program Director at MDIC
  • Garth Conrad, VP Quality at BD Peripheral Intervention
  • Michael Ruhlen M.D., MHCM, FAAP, VP Division of Medical Education, Atrium Health
  • Michael Schiller, CMRP, Senior Director at the Association for Healthcare Resource & Materials Management (AHRMM)
  • Nathan Soderborg, Ph.D., Principal Scientist, Statistical and Data Sciences, Exponent.
  • Francisco (Cisco) Vicenty, Program Manager for Case for Quality, OC, CDRH, FDA

Continue reading the full article in MedTech Intelligence.

Related

NBC News Reports – Device-Safety Experts to FDA: Make Data Public.

Download the full report and read our interview with CfQ PQOA stakeholders.

 

 

26Mar/19
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New Whitepaper Series – Why MedTech Must Embrace Industry 4.0

Medical Device Companies Must Embrace Modern Manufacturing Execution System (MES) Strategies to Future-Proof Their Business

By: Sandra K. Rodriguez, Market Analyst

FDA’s upcoming guidance on Computer Software Assurance (CSA) paves the way for Digital transformation and Industry 4.0 in MedTech. The Agency recognizes that systems like MES provide manufacturers advantages for reducing or eliminating errors, increasing business value, optimizing resources, and reducing patient risk.

Need a roadmap to enable Industry 4.0 in MedTech?  Read this whitepaper series to discover:

  • How to use MES as the backbone to enable Industry 4.0
  • Why modern MES support the transition from compliance to excellence
  • How to enable a step change for your business and patient outcomes
  • Ways to utilize Industry 4.0 across your manufacturing network

Download the series here and start your digital manufacturing transformation.

This white paper series was sponsored by Critical Manufacturing.

22Mar/19
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FDA Shares Quality Considerations for Continuous Manufacturing

A Straight from the Source Webinar Available On-Demand

 FDA is committed to supporting and enabling pharmaceutical innovation and modernization. The Agency recognizes that continuous manufacturing is an emerging technology that can enable pharmaceutical modernization and deliver potential benefits to both industry and patients.

Join FDA’s Thomas O’Connor, Ph.D. and Axendia’s Daniel R. Matlis for a live webinar.

Original Webinar Date and Time:  April 17th at 11:00 AM ET. 

We will discuss FDA’s perspective on pharmaceutical innovation and modernization including:

  • FDA’s draft guidance on Quality Considerations for Continuous Manufacturing
  • How continuous manufacturing can improve pharmaceutical manufacturing
  • Support of enhanced development approaches such as quality by design (QbD), process analytical technology (PAT) and models
  • Insights from dialogue with sponsors through the Emerging Technology Program, externally funded and internal research
  • Experiences from review and approval of five drug applications utilizing continuous manufacturing to date

Meet Your Trusted Sources

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Register to view this webinar on-demand.

register