Quality Culture Matters: Key to Unlocking the Digital Validation Power

Extended Learning
Learning Level: Intermediate
Session Length: 1 hour

The forthcoming ISPE Good Practice Guide: Digital Validation emphasizes that a robust quality culture is foundational for successful digital validation implementation. This webinar, by ISPE Digital Validation Subcommittee members, George Brunner, Dori Gonzalez-Acevedo, Amy Kuntzman, and Khaled Moussally, explores key guide components, the shift to digital validation, and strategies for fostering collaboration and continuous improvement. By focusing on quality culture, organizations can enhance risk management, governance, and overall effectiveness of digital validation tools.

Learning Objective

  • Educate on Key Components: Provide an in-depth understanding of the key components and the purpose of the ISPE Good Practice Guide: Digital Validation, emphasizing the benefits and processes of transitioning from traditional paper-based validation methods to digital solutions.
  • Highlight the Importance of Quality Culture: Explain why a robust quality culture is crucial for the successful implementation of digital validation tools and discuss strategies to foster such a culture within organizations, including breaking down silos and encouraging integrated collaboration.
  • Promote Best Practices and Governance: Share best practices for continuous improvement and innovation, outline governance and change management strategies to support digital validation adoption, and offer practical steps for companies starting their digital validation journey.

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Speakers

Amy Kuntzman
Principal Consultant
CAI
Dori Gonzalez-Acevedo
CEO and Co-Founder
ProcellaRX
Khaled Moussally
Executive Vice President Clients & Regulatory Relations
Compliance Group Inc
George Brunner
Chief Data Scientist
Acumen Analytics, Inc.

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