Category Archives: Webinar

12Feb/21

FDA Debunks Industry Myths on Electronic Batch Records and Review by Exceptions

Automating Electronic Batch Record review is a key benefit of Modernizing Manufacturing Operations. Yet concerns regarding FDA’s acceptance of Review by Exception (RBE) has prevented many companies from achieving this goal.

In this “Straight from the Source” episode, FDA’s Francisco Vicenty debunks industry myths on Electronic Batch Records and Review by Exception.

05Feb/21

2021 Forecast for the Life-Sciences Industry

Industry must adapt and overcome current and future disruptive trends on the horizon. To assist in this effort, Axendia revealed the 2021 Life-Sciences Radar.

In this episode of Straight from the Source, Axendia’s President and Founder, Daniel R. Matlis and Sandra K. Rodriguez, Market Analyst discuss how major disruptions in 2020 have accelerated key modernization initiatives to support resilience through the Life-Science value network.  They also address the need for interdependence across these transformational initiatives to overcome business, regulatory, technology and cultural inertia and plot a course to success.

13Jan/21

FDA Shares Insights on Digital Transformation & Manufacturing Modernization

The FDA has recognized that current perceptions and approaches to computer system validation (CSV) are a significant barrier to Digital Transformation and Manufacturing Modernization.  The Agency is working swiftly to reverse this trend through the transition to Computer System Assurance (CSA).

In this webinar, FDA’s Francisco Vicenty and Axendia’s Daniel R. Matlis discuss the Agency’s insights on Digital Transformation & Manufacturing Modernization.

Watch this webinar to gain FDA’s perspective on:

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24Nov/20

Sanmina Medical Embraces Cloud MES To Optimize Manufacturing

By Daniel R. Matlis

Sanmina’s Medical Division manufactures a wide range of products and systems for well known medical OEMs including laboratory, biotechnology, diagnostics, therapeutic, patient monitoring and surgical equipment.

For 7 years, Sanmina’s Medical Division has embraced Cloud-MES to optimize manufacturing operations and elevate operational performance.  

To gain a deeper understanding of Sanmina’s journey to Cloud-MES, I interviewed Seán Moran, VP of Operations and Plant Manager at Sanmina Ireland and Wellington Giolo, Head of Sales & Strategic Alliances at 42Q. 

In this Straight from the Source webinar, we discussed:

  • Trends Enabling Cloud-MES in Life-Sciences
  • Sanmina Medical Division’s Cloud-MES Journey
  • FDA’s Role Incentivizing SaaS, Cloud and Manufacturing Modernization
  • The Value of Cloud-MES across Business, Technology & Regulatory Dimensions
  • Managing Medical Device Production in The Age of Disruption

This event brief covers key points from our interview as well as audience questions.

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25Sep/20

Embracing Cloud MES to Optimize Manufacturing at Sanmina’s Medical Division

An Axendia Straight from the Source Webinar

Seven years ago, Sanmina’s medical division implemented a cloud-based MES platform, to elevate operational performance and have experienced rapid implementation times, accelerated time to value and simplified access worldwide.

Join Daniel R. Matlis, President at Axendia, Sean Moran, VP of Operations and Plant Manager at Sanmina Ireland and Wellington Giolo, Head of Sales & Strategic Alliances at 42Q, for a live webinar on October 21 2020 at 10:00 AM ET, as they discuss how leveraging a cloud-based MES platform can improve visibility and control, especially during pandemic-related disruptions.

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