Thursday, October 17, 2024
11AM – 12:15 PM EST

Presented by:

Saradha Ramamoorthy
Head, Strategic Consulting – India
Compliance Group Inc.

David .P.Deluca
Director, Strategic Consulting
Compliance Group Inc.

Senthil Gurumoorthi
Principal, Global Lead-
Healthcare & Life Sciences, Security & Compliance
Amazon Web Services

  • Understand Agile vs. Waterfall Methodologies: Explore the key differences between Agile and Waterfall approaches, and learn how each impacts the software development lifecycle (SDLC)
  • Identify Pitfalls in Agile Adoption: Overview common challenges organizations face when integrating Agile into their QMS validation lifecycle.
  • Compare Traditional CSV with Agile CSA: Analyze the differences between traditional Computer System Validation (CSV) methods and Agile CSA practices, highlighting the benefits of adopting Agile.
  • Explore the Core Principles and Benefits of Agile CSA: Grasp the foundational concepts that define Agile CSA and how they can enhance software quality. Additionally, discover how Agile CSA enables increased delivery, collaboration and overall software quality.
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SPEAKERS

David DeLuca
Manager – Validation and Data Integrity, Compliance Group

David DeLuca has 10+ years of experience in medical device and pharmaceutical manufacturing and is an expert on Process Validation and Design Control. With a strong background in process design, development and implementation, David understands the hurdles that organizations face when executing validation. David has contributed to many remediation projects focused on compliance to FDA validation requirements and understands the importance of critical, risk-based thinking when applying these principles.

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