The Quality 4.0 Impact
How to Achieve Study-Based Audit Efficiencies
within a Compliance Framework

An FDAnews FREE Webinar • Sponsored by Xybion
Tuesday, Oct. 18, 2022 • 11:00 AM - 12:00 PM EDT

The evolution of Quality 4.0 allows organizations to focus on a collaborative approach towards quality and compliance to simplify regulatory audit processes. With Quality 4.0, companies are leveraging an agile QMS solution to streamline processes, ensure audit-readiness, connect global partners, and mitigate compliance risks.

Join Xybion, an innovative solution provider to all the top 20 life sciences companies, for a live event entitled, The Quality 4.0 Impact: How to Achieve Study-Based Audit Efficiencies within a Compliance Framework on Oct. 18 at 11:00 am EDT.

Three senior directors with decades of experience at the intersection of quality and technology in the life sciences: Amy Carlson, Subject Matter Advisor and Training Leader; Anu Ganguly, Senior Director; and Angie Bixler, CQRM Product Manager, will share how an agile QMS can increase study-based audit efficiency within a pharmaceutical organization and/or a CRO’s compliance framework.

You will discover:

  • How to harmonize integration of quality and compliance
  • How to achieve optimal quality management system efficiency
  • How to achieve study-based audit efficiencies within a compliance framework
  • How to use audits to drive continuous improvements
  • How to align global organization with unified process and approach
  • How to allow for future scalability
  • How to seamlessly integrate with Suppliers, Manufacturers and CROs

Please attend the free webinar by registering today to start creating audit efficiencies within a compliance framework.

Who Will Benefit

  • Compliance personnel
  • Regulatory personnel
  • Quality personnel
  • Medical directors
  • Clinical operations personnel
  • Clinical management personnel
  • IT personnel

Sign Up for FREE Below

Meet Your Presenters

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Amy L. Carlson

CQRM Product Manager
Xybion

Amy Carlson more than twenty years of experience at a global engineering firm and three software companies, including Xybion, where she has held various scientific and product consulting, delivery and leadership positions. She has designed and implemented quality, compliance, risk, governance, health and safety and environmental software and has authored several papers on related subjects. She currently manages the Training Center of Excellence and provides training for global clients on CQRM. In addition, she provides best practice, lean processing and subject matter advisement and delivery services for Xybion’s clients.

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Anu Ganguly

Senior Director, Strategic Client Partner
Xybion

Anu Ganguly has more than 15 years of professional services experience with life sciences companies and extensive expertise in designing and deploying innovative and transformative solutions with a concentration on clinical trial management, sales, marketing effectiveness and business intelligence programs. At Xybion Anu’s focus is on driving strategic growth for the CQRM product line. Her expertise includes, managing cross-functional teams, developing and implementing governance and operational strategy, optimizing processes and building professional teams to exceed business objectives. Before joining Xybion, she was managing engagements for Verily, a Google company, Syneos Health, Infosys Consulting, EY and Accenture.

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Angie Bixler

CQRM Product Manager
Xybion

Angie Bixler has more 20 years of experience in the Life Sciences Industry, focused on quality systems and IT compliance. Throughout her career she has led numerous global QMS software implementations and upgrades in addition to leading many other software development projects. An analyst to her core, Angie thrives on building the most efficient and compliant applications to fit customer needs.