• Digital Transformation

  • careers

  • Internet of Medical Things Banner Home

  • careers

 
 
 

Events

David Blewitt, VP or Cloud Compliance at USDM Life Sciences will be presenting at the DocuSign Life Science Focused Event on November 15th, 2018 in Cologne, Germany. The life sciences industry, which is characterised by complex country-specific approvals, regionally different regulations and a variety of different communication channels, is responsible for efficiency gains through further digitisation measures. Integrating new and secure digital opportunities into existing structures enables life science companies to overcome existing barriers, has the potential to significantly accelerate processes and also make them more cost-effective. Electronic signature is an important element of digital transformation that should be considered in particular to bridge media disruptions with external partners. Cumbersome approval or signature processes can be reduced from a few weeks or days to a few hours with electronic signatures-permits and signatures become possible anytime, anywhere. DocuSign invites customers and interested companies to exchange experiences on DocuSign and the use of…
David Blewitt, VP or Cloud Compliance at USDM Life Sciences and Elaine Wan and Aravindan Sankaramurthy from Oracle will be presenting, "A Risk-Based Approach to Manufacturing Regulations and Audits" this week at Oracle Open World. Learn about the latest features of Oracle Manufacturing Cloud that enable customers to implement a risk-based approach to comply with customer and industry regulations for quality, safety, and audits. Topics span multiple industries and include closed-loop quality management, electronic signatures and records, lot and serial genealogy, and a robust process by USDM to validate the cloud environment per FDA CFR part 11 requirements. Date & Locations Thursday, October 25th, 2018 11:00am - 11:45am Moscone South - Room 105 Click here for more information      
USDM Life Sciences and Box are excited to offer complimentary GxP Lunch and Learn sessions on October 23rd and 25th, 2018 “Regulated and Unregulated Content, Now in the Same Cloud” Join Box and USDM to learn how companies are transforming the way GxP data is managed and exchanged, ending the silos between their regulated and unregulated content.  With the Box GxP Validation, this means all of your content is standardized on a single content platform that meets regulatory and compliance standards, so you can eliminate inefficient silos, enable seamless collaboration and accelerate the validation process. Agenda   11:30-11:45: Registration 11:45-1:00: Box GxP Validation with USDM 1:00-1:15: Q&A 1:15-1:30: Networking   Dates & Locations Session 1 - Tuesday, October 23rd, 2018 Tabor Road Tavern   510 Tabor Rd Morris Plains, NJ 07950 Register for Session 1   Session 2 - Thursday, October 25th, 2018 Commonwealth 11 Broad Canal Way Cambridge, MA 02142 Register for Session…
The USDM team will be at the EtQ User Conference in Orlando, FL, October 15 - 19, 2018: “Building the Foundations of Compliance” Monday, October 15th-19th 10:00am - 5:00pm Our theme for this year's conference is the "Foundations of Compliance".  Our goal for 2018 is to take a more practical approach to the User Conference, and build out sessions that will provide you with more practical experience in processes and platform configurations. In addition, we are taking a case study approach and building more sessions around customer examples of how they have implemented Reliance for their business.   Click here for details and the full agenda
David Blewitt will be speaking at the 11th BSMA Conference in San Francisco, CA, October 11, 2018: “Pivoting Data – Product, Manufacturing and Quality – to the Cloud” Thursday, October 11th 7:30am - 7:00pm Companies employ different research and operations models to succeed in this demanding new healthcare environment. One common challenge across these models – discovery, development and launch of new products – is management of product and process data and be able to interface with regulatory demands of the government.  Furthermore, the necessary business transactions between a drug discoverer, clinical trials support services, CROs, governmental regulatory agencies, CMOs, internal manufacturing, distribution and patient care are of gigantic proportions, fraught with disconnects, errors, delays and lack of 100% integrity. Solutions will be presented for Pivoting data (Product, Manufacturing and Quality) to the Cloud. Access to an integrated data platform in the Cloud where validation and maintenance of data is decentralized and the ability…
Jay Crowley will be speaking at the GS1 Connect Conference in Phoenix, Arizona, June 5, 2018: UDI Around the Globe Tuesday, June 5th 3-3:45pm There are many new UDI and UDI-like requirements being introduced globally.  All of these are intended to bring visibility, control, and connectivity to the many related regulatory and commercial device-related activities. These activities cover the total lifecycle of a device and will ultimately include long-term safety, effectiveness, and value.  All of this requires manufacturers to have a level of control and visibility over their products and processes, which probably does not exist today, and may require new systems to support these activities.  This talk will outline the roadblocks to compliance as regulations are enacted and how to overcome them.  Click here for more information 
Join USDM at the MedTech Summit 2018 in Brussels, June 12-13, 2018! Jay Crowley, VP of UDI Services and Solutions at USDM will speak on June 12, 2018 from 10:20-10:45am: The Big Picture: UDI and the Product Visibility and Control Imperative There are many new UDI and UDI-like requirements being introduced globally. All of these are intended to bring visibility, control, and connectivity to the many related regulatory and commercial device-related activities. These activities cover the total lifecycle of a device – including design, manufacturing, distribution, and postmarket surveillance – and will ultimately include long-term safety, effectiveness, and value. All of this requires manufacturers to have a level of control and visibility over their products and processes that probably do not exist today, and which may require new systems to support these activities.  USDM will exhibit at the event; please stop by our booth, #14, on June 12 or 13th.…
Join the MedTec Europe 2018 conference in Stuttgart, Germany, where Jay Crowley, VP of UDI Services and Solutions at USDM Life Sciences will speak during two sessions: Breakfast Meeting at MedTec Europe 2018 Wednesday, April 18 10:00-10:45 Why start now: A practical approach to kick-starting your MDR/ IVDR implementation   Regulatory Update Wednesday, April 18 16:00-16:30 Processes and steps for managing UDI for the FDA, the EU MDR/IVDR, and other regulators globally   Medtec Europe is the preeminent medical technology platform showcasing the key trends and insights across the entire supply chain of the medical technology industry. It also serves as a prime location for business opportunities and start-up companies looking to present their innovations to investors.  The event brings together companies in the medical device supply chain to share ideas, meet partners, and discover, experience and source products & services from all stages of production in order to create the next generation of…

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
See all Testimonials