Jaime Velez, Co-founding Partner and Senior Consultant at Operations and Quality Systems Improvement Experts (OQSIE), will join us at the American Medical Device Summit 2019, where he will speak about “Leveraging Technology and Artificial Intelligence to Accelerate Improvements in Effectiveness and Productivity in the Supply Chain.” Ahead of the summit, we spoke to Jaime about the importance of leveraging artificial intelligence (AI) and business intelligence (BI), how medical device manufacturers can begin to do this, and how OQSIE can help.
EU MDR: Q&A With MAE Group
Significant changes are ahead for medical device manufacturers.
The EU’s Medical Device Regulation (EU MDR), which is set to replace the current directive for the regulation of devices in 2020, will introduce significant regulatory changes that will impact all organizations producing or supplying medical device products to Europe.
Ahead of the American Medical Device Summit 2019, Generis Group spoke with Yashesh Rawal, Regulatory Affairs Specialist from MAE Group, to discuss the major challenges of the new EU MDR, its impact on medical device manufacturers, and how organizations can prepare to ensure a smooth transition.
Checklist for Establishing an Overseas CGT Operation
Cell and Gene Therapy (CGT) is a major breakthrough in medical science. Since penicillin, the world’s first antibiotic, was discovered in 1928, there has been measured progress in the development of new medicines. With the innovation inherent in being able to modify cells to treat or cure diseases, one of the biggest challenges today for U.S. biopharma companies during these early years for CGT is finding robust, repeatable and scalable ways to manufacture these life-saving products and test to ensure they are safe and effective therapies. Setting up a European operation can help American biopharma companies speed up their reach as a next step in medical care and get these advanced treatments to a wide patient population.
American Automotive Summit Gathers Manufacturers to Discuss Process Strategy, Supplier Oversight, Quality and Innovation
From September 16-17, automotive manufacturers and executives are meeting in Detroit to discuss strategies to optimize manufacturing and R&D in the American automotive industry, drive innovation in a competitive landscape, maximize supplier relationships, and mitigate costs.
Bringing Precision Medicine to Market
When it comes to biopharmaceutical drug discovery and development, we live in an incredible time. The FDA has approved innovative medicines with differing approaches, platforms, technologies, and modalities. As we leverage new technologies, our strategies for drug discovery are leading to therapeutic diversity, which is rapidly becoming a complicated landscape for manufacturing teams.
Reducing Cleaning and Cross-Contamination Risk in Single-Use Powder Handling
In June 2019, ILC Dover will join biopharmaceutical executives to discuss current trends, strategic insights, and best practices in manufacturing, outsourcing, capacity management, quality assurance, quality control, regulatory compliance, operational excellence, supply chain, and logistics at the American Biomanufacturing Summit 2019.
On June 2018, ILC Dover will present the topics, “Reducing Cleaning and Cross-Contamination Risk in Single-Use Powder Handling”. Their case study presentation will focus on how cleaning validation is getting more difficult as the industry gets better at detecting dust and particles; enabling rapid turnover of campaigns to get to market faster; and how powder handling is a bigger challenge than liquid handling, and why it is often overlooked as a potential source of contamination.
Ahead of the American Biomanufacturing Summit, Generis spoke with ILC Dover to discuss their upcoming session, key challenges in the pharma and biopharma industries, and why companies choose to work with ILC Dover.
This is an excerpt from the Q&A we did with ILC Dover:
“What evolving containment needs are the pharmaceutical and biopharmaceutical industries currently facing?
Digital Transformation: Driving Behavior Change
Companies everywhere seem eager and ready to invest in digital transformation strategies, but are they achieving results? The numbers so far seem to indicate that the answer may be a resounding “no.” Studies continue to show that up to 80% of transformation efforts fail to achieve their intended goals.
Ahead of the American Biomanufacturing Summit 2019, Generis Group spoke to Kim Huggins, partner at ALULA, to discuss why digital transformation is one of the most complex and disruptive initiatives an organization can experience.
The Industrial Cloud is Here. Are You Prepared for the Cybersecurity and Interoperability Challenges?
In May 2019, Waterfall Security will join IT executives and industry leaders to discuss current trends, strategic insights and best practices in technology, cyber-security, risk management and managing talent at the American CIO & IT Summit 2019.
Ahead of the American CIO & IT Summit, we spoke with Waterfall Security to discuss what challenges companies face from cyber attacks, what steps companies need to take to leverage their solutions and why companies choose to work with them.
The Future of Manufacturing – with SwipeGuide CEO Willemijn Schneyder
SwipeGuide Co-Founder and CEO, Willemijn Schneyder, shares what’s next in manufacturing technology:
Willemijn, thanks so much for the interview. What about your work excites you the most?
We’re really excited about what’s happening in the industry today. The manufacturing and heavy machinery industries are moving away from a human-powered, mechanical workforce to become an automated shop floor with tech-savvy workers.
Any company’s goal is to be competitive in a connected, data-driven, and ultimately more productive world. But as technology evolves, they’re left with very real problems. Obsolete hardware, difficulty capturing and sharing knowledge, and integration with a new generation of workers all cause major issues for modern businesses.
Using AI-Based Vision and Acoustic Solutions: Q&A with Clear Intelligence
In May 2019, Clear Intelligence will present on the topic, Art of the Possible: Using AI-Based Vision & Acoustic Solutions at the American CIO & IT Summit 2019. Brian Murphy, Chief Innovation Officer at Clear Intelligence, will lead the session, examining the fundamentals of AI-based vision and acoustic solutions, its business value drivers, and industry insights on how companies are utilizing these solutions.
Generis Group spoke with Brian ahead of the American CIO & IT Summit 2019 to discuss his session, the benefits of AI-based vision and acoustic solutions, Clear Intelligence’s five-step DIDIT process, and the future of the IT industry.