Tag Archives: Straight from the Source

01Oct/19
digital transformation

Culture Change Management in Support of Digital Integration at Fresenius Medical Care

A Straight from the Source Webinar

To support changing regulatory frameworks and business models, forward thinking Life-Science companies like Fresenius Medical Care are not just considering digital integration but are implementing strategies that unify Product Lifecycle Management (PLM), Quality Management Systems (QMS), Manufacturing Execution Systems, (MES), Enterprise Resource Planning (ERP) and a variety of other software solutions.

To assure improved outcomes, all these systems must ultimately coexist which is why a digital integration strategy is critical.

In this Straight from the Source Webinar featuring Bill D’Innocenzo, SVP of Digital Integration at Fresenius Medical Care, we discuss why Digital Transformation is a Journey… Not a Project! We will also review why transforming organizational culture and behaviors is imperative to ensuring the success of new business models in support of improved outcomes.

Join Fresenius Medical Care’s Bill D’Innocenzo and Axendia’s Sandra Rodriguez for a live webinar on October 30th at 11:00 AM ET.

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Key Takeaways:

• 5 Steps to a Successful Digital Integration Strategy
• Why you must build a cross-functional team during the digital transformation journey
• Why transforming organization culture first is imperative to supporting new business models
• The road to a successful digital integration strategy is first paved by the people leading the change

Register and watch this webinar On-Demand.

register

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  • FDA’s draft guidance on Quality Considerations for Continuous Manufacturing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

dan and thomas SFTS image

Register to view this webinar on-demand.

register

05Mar/19
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Disruption is on the Radar! You Must Plot a Course for Success.

Webinar Available On-Demand

Disruption is on the radar! Life-Science executives must plot a course for success.  That was the theme of our “Straight from the Source” webinar featuring Axendia’s President, Daniel R. Matlis and Sandra K. Rodriguez, Market Analyst, on February 20th.

Since 2005, Industry stakeholders and regulators have relied on Axendia for trusted advice on Business, Regulatory and Technology issues and trends.  Due to our track-record of accurately predicting Life-Science trends, our clients often ask us to forecast what’s on the horizon.

To answer this question, we developed a Life Science radar to communicate our focus areas in the markets we service, as well as share when we predict these trends will become mainstream. Continue reading