Managing Compliance Risk in Life Sciences: How Can IT and Quality Teams Root it Out

Life Sciences, Pharmaceutical Regulation, Pharma,
  • Tuesday, September 24, 2024

Information technology (IT) and quality teams in life sciences organizations can both protect and deliver exceptional value by developing a systematic way to assess and grade risk, strengthening IT–quality collaboration and pre-emptively developing a strategy to incorporate artificial intelligence (AI). The complete understanding of a company’s risk profile is crucial to all these initiatives.

The IT and quality teams face difficult challenges: managing the many compliance risks that come with an influx of new technology. A rising cadence of software releases and updates, the need to manage more data and the gradual implementation of artificial intelligence (AI) has created real risk-based problems that need solving. Therefore, a strategy to define and remediate risk in the face of emergent technology is paramount. Quality systems must adapt to accommodate these sea changes and effectively manage risk moving forward, with IT as a primary driver.

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The three ways to do that include taking a full measurement of your technology-based risk, bolstering collaboration between IT and quality and preparing for AI integration (and identifying ways to derive value from it). The teams responsible for ensuring compliance must have a strategic, systematic way to assess and manage risk; one that keeps pace with the growing number of releases per year.

This includes standard operating procedures (SOPs) and best practices. Automation can play a significant role here, which will be explored during this webinar. These teams must also work closely alongside IT to ensure safe, effective and efficient implementation. The right preparation, knowledge and skill sets can turn AI into a value generator across a variety of use cases from clinical development through the commercial lifecycle.

The relationship between IT and quality teams manifests as a negotiation when it should play out organically and collaboratively. Both teams have salient insights that are worth sharing across the entire risk remediation process.

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Register for this webinar today to bridge the gap between IT and quality teams and mitigate compliance risk by leveraging new technologies in life sciences organizations.

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Speakers

Ellen Reilly, Sware

(Moderator) Ellen Reilly, Chief Executive Officer, Sware

Ellen Reilly is an industry leader that has focused on the intersection of life sciences, technology and data. Ms. Reilly is the CEO of Sware and has been working with IT and quality organizations for digital transformation strategy for the past four decades.

Ellen has led large organizations in driving change to transform and simplify business processes while delivering bottom-line measurable benefits. Ellen has worked for a variety of global pharmaceutical companies, including Roche, Forest and Centocor. Besides industry experience, she was a Partner at BearingPoint/PwC consulting as well as led the Healthcare and Life Sciences business at DocuSign.

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Ellen attended La Salle University in Philadelphia where she received a Bachelor of Arts in Computer Science and went on to Drexel University’s LeBow School to receive an MBA in International Business. Ellen received La Salle University’s prestigious IT Leadership Award in 2018 and is currently the Chair of the Board of Trustees.

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Message Presenter
Tracy Founds, Glaukos Corporation

Tracy Founds, Sr VP Global Quality & Medical Safety, Glaukos Corporation

For more than 30 years, Tracy M. Founds has served in Quality and Medical Safety leadership roles in the biotech industry focusing on Quality and Compliance throughout the product lifecycle. Among other critical elements of compliance, she is responsible for oversight through effective Quality Management Systems, including, but not limited to, digital transformation, software as a product, and CSV/CSA. Tracy is passionate about ensuring patient safety through phase-appropriate, risk-based compliance activities

Message Presenter
Bradley Lambert, AGC Biologics

Bradley Lambert, Vice President Global IT, AGC Biologics

Bradley Lambert is a seasoned Information Technology leader with over 20 years of experience driving innovation and IT strategies in the biotechnology industry. Recognized for proposing and leading complex IT programs, he effectively manages global strategies across various functions, including Manufacturing, Quality, Validation, Quality Control, and Supply Chain. Bradley is committed to advancing governance and efficiency in business, IT implementations, and IT operations, supporting corporate strategic goals through enabling technologies and global digitalization.

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Have questions or would like more information? Use the form below to send a message.

Who Should Attend?

This webinar is intended for IT and quality professionals who are responsible for managing organizations technology, including optimizing investments, identifying risk and being audit-ready.

  • Head/Director of IT
  • Chief Information Officer
  • Head/Director of Quality

What You Will Learn

Attendees will learn about:

  • Derisking investment in technology using best practices and proven playbooks
  • Integrating new solutions into the technology ecosystem, including AI
  • Collaborating across functions to ensure effective implementation and sustainable success

Xtalks Partner

Sware Logo

Sware

Sware’s mission is to rescue life sciences companies from the grip of validation debt; the unpaid cost of release, testing, GxP, and business requirements. The Res_Q™ software platform offers the most complete validation solution available today. Res_Q eliminates validation debt and ensures peace of mind in an increasingly complex technology ecosystem. For more information, visit www.sware.com.

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