Oct142024
Webinars

Navigating GxP compliance challenges

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Don’t miss this opportunity to enhance your GxP compliance journey

In the constantly changing technology landscape, the implementation of transformative computerized systems is crucial for biopharma companies to support the development, manufacturing, and delivery of life-saving drugs. For systems that support GxP-regulated activities, ensuring compliance with applicable regulations such as FDA 21 CFR Part 11 and EudraLex Vol. 4 Annex 11 is compulsory. However, achieving full compliance in your digital transformation can be challenging, costly, and time-consuming for many organizations.

Software vendors, particularly SaaS providers, play a critical role throughout the entire lifecycle of computerized systems. Therefore, it is important to partner with a trusted supplier experienced in the GxP-regulated space. By understanding your risk tolerance, a trusted supplier can be leveraged to mitigate risk and reduce the overall compliance burden for organizations.

Join us for an informative webinar where you will learn:

  • The regulatory requirements for selecting and managing a supplier
  • Strategies to mitigate risks when choosing a GxP compliant supplier
  • Important attributes to identify in a trusted partner
  • How to leverage supplier expertise and effort to achieve desired outcomes

We will share real-world examples of the challenges our customers typically face and how IDBS has helped them overcome these obstacles. Stay informed on industry trends and future risks with insights on how a trusted partner safeguards your data for new technologies.

Don’t miss this opportunity to enhance your GxP compliance journey.

Watch the Webinar

Meet our speakers

Jim Brooks

Jim Brooks

Lead Platform Product Manager for GxP Strategy, IDBS

Jim Brooks is the Lead Platform Product Manager for GxP Strategy at IDBS. In this role, he is accountable for defining and delivering initiatives focused on assisting customers in achieving and maintaining compliance with applicable GxP computerized system regulations. His long-standing career spans over 20 years in BioPharma, including roles in QC, QA and IT where he was responsible for validating, deploying and managing laboratory information systems in GxP-regulated environments.

Fran Carmody, Services Enablement Manager at IDBS

Fran Carmody

Services Enablement Manager, IDBS

Fran is responsible for unlocking the value of the IDBS platform to solve some of the hardest challenges in emerging and global BioPharma companies and their contractor partners. Before that, Fran led the Global Professional Services team, responsible for customer transformation to a culture of data with the implementation of the IDBS technology stack.

Before joining the IDBS team in 2012, Fran was a consumer of IDBS technologies while working with several start-up biotech companies, focused on novel immunotherapies, including monoclonal antibodies and small molecules.