Tag Archives: Axendia

28May/19
Dan and Cisco 2019 Webinar

FDA Answers Your Questions on the New Approach to CSV

Q&A from an Axendia Straight from the Source (SftS) Webinar

By: Francisco Vicenty, FDA, CDRH and Daniel R. Matlis, Axendia, President

In our recent webinar, we discussed FDA’s perspective on Computer Software Assurance (CSA).  FDA has recognized that existing perceptions and approaches to computer system validation (CSV) are a significant barrier to improving digital capability, product quality, and patient safety and is working swiftly to reverse this trend.

In this “Straight from the Source” webinar, we discussed FDA’s perspective on CSA including:

  • FDA’s upcoming Guidance on CSA for Manufacturing, Operations, and Quality System Software
  • Applying critical thinking and risk-based principles to support technology modernization
  • Identifying Acceptable Records of Assurance
  • Leveraging CSA to accelerate digital transformation

There were many more questions submitted than could be answered in the time allotted.

Register and receive your internal-use copy of the full Q&A.

 

 

21May/19
IoPP Logo

Puerto Rico Packaging Summit 2019

Event Brief

By: Sandra K. Rodriguez, Market Analyst

The Puerto Rico Packaging Summit 2019 took place in Condado, Puerto Rico.  The summit focused on the Institute of Packaging Professionals (IoPP) – Puerto Rico Chapter’s core organizational value: Packaging Contribution.  The Summit drew 129 attendees, representing 48 companies.

The message was simple and clear: We Speak Packaging. Speak Packaging With Us.

IoPP PresentersToday, advanced technologies including deep learning, artificial intelligence and robotics are playing a key role in an important piece of the supply chain and manufacturing processes.  Presentations by Amgen, Adents, Rockwell Automation, Pfizer and Hi-Tech Products demonstrated not if or when, but how automation and technology is already impacting manufacturing and operations in the Life-Sciences.

Jorge Delgado, Sr. Manager of Process Development at Amgen explained that deep learning can help overcome some challenges in Automatic Visual Inspection (AVI).  “Even with multiple techniques, it is still a challenge to effectively detect particles using current AVI technologies for particle detection,” said Delgado. Continue reading

15May/19
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Supply Chain Visibility: A Regulatory Necessity and Business Imperative

Brand owners are legally responsible for the safety, efficacy and quality of their products

By: Daniel R. Matlis, President

The globalization of life science products has created unique opportunities and demanding challenges for both industry and regulators.

The globalization and outsourcing of life science products began in the late 1990s. At the time, life science companies began to evaluate their core competencies and decided to outsource non-core competency functions. The primary reason for this trend was to lower costs.

Globalization has also opened new markets for life science products worldwide, with emerging economies representing fresh markets. Concurrently, issues with supply chain security became the responsibility of all parties involved in the procurement/sourcing, manufacturing, packaging and distribution of raw materials, intermediates, and final product to deliver safe and effective medicines to customers.

Recommendations for a New Supply Network Paradigm
Supply chain dynamics are prompting life science companies to seek innovative approaches that improve product safety while simultaneously enhancing clinical outcomes, reducing costs and risks, and ensuring regulatory compliance. To attain the sustained benefits of globalization, the life science products ecosystem must implement a new paradigm to manage global supply chains.

770_mainCompanies must implement new strategies while proactively reducing and controlling risks. This calls for changing the business, technology, and regulatory models traditionally used in the industry. The three key components to managing this shift are on-demand visibility, supply network control, and collaboration.

Continue Reading This Article in Medical Product Outsourcing

01May/19
Living-heart-project

Axendia to Provide Life-Science Analyst Keynote at 3DEXPERIENCE FORUM 2019

Harnessing Positive Disruption in Life Sciences to Achieve Patient-Centric Care

By: Daniel R. Matlis, President

Life-Science organizations must transform or be disrupted! They must harness positive disruption to achieve patient-centric care that supports prevention, improves outcomes as well as providing a holistic patient experience that drives value.

However, to achieve patient-centric care, Life-Science organizations must undergo digital transformation that enables closed loop visibility across the product lifecycle. This transformation requires core paradigm shifts in corporate culture, incentives, strategic planning, regulatory frameworks as well as technological solutions for industry stakeholders.

Male-Anatomy-Background-composite-cropped-low-resNew technologies like modeling and simulation, artificial intelligence and the Internet of Medical Things (IoMT) are enabling patient-centric models to serve more people around the world. The foundation of patient-centric care is the ability to connect the real and digital worlds through multi-discipline, multi-scale modeling and simulation, IoMT connected devices, visibility to data for decision support and greater collaboration. Continue reading

29Apr/19
Image Source: Tel Aviv University

Taking 3D Printing to Heart…New Steps in 3D Printing Medical Applications

Is 3D Printing Still a Phenomenon… or Not?

By: Eric M. Luyer, Industry Research Analyst

3D Printing has been used for some time now for printing very specific surgical tools or patient-specific parts to complete full functioning of the human body.  But is 3D Printing still a phenomenon… or not?

In my opinion it is certainly amazing when you see the latest developments and you apply biomedical engineering to 3D Printing.  Specifically, in the medical field there are various use cases adopting this rather futuristic technology – you may now print entire organs for practical surgical use!   I have read that scientists and researchers have successfully printed kidney cells, sheets of cardiac tissue that have something like a heartbeat, and foundations for a human liver.

Other relatively new examples are:  bio-printed stem cells which has been done by the Heriot-Watt University of Edinburgh, Scotland-UK of human skin, that can be used for burn victims, skin cancer patients or other kinds of diseases that affects the skin in a negative way. Scientists have also successfully created tests for 3D Printing artificial bone tissue(!) and the hope is that such tissues may assist in helping with limiting sporting accidents that so many athletes suffer from.  I have also seen that medical researchers and scientists are well on their way to printing an entire human organ. Continue reading