The Prediction Impact
Reduce Compliance Risks with Novel AI and ML Technology

An FDAnews FREE Webinar • Sponsored by Xybion
Tuesday, June 28, 2022 • 11:00 AM - 12:00 PM EDT

How would you like to see reduced compliance risk, faster time to market, lower costs, enhanced decisionmaking and more?

You can, when your compliance model is integrated with artificial intelligence (AI) and machine learning (ML). This free webinar will explain how such a predictive system can identify and mitigate compliance risks and ensure uniform quality and compliance across every level and site within your organization.

Four Xybion executives with decades of experience at the intersection of quality and technology in the life sciences will share how these digital tools can recognize and diminish your compliance risks.

Kamal Biswas, president and COO; Heidi Krueger, director of quality assurance; and Bob Friedman, chief technology officer will empower you to go from reactive to proactive, getting ahead of your gaps — and the regulators — so you can avoid 483s and the recalls, remediation and other negative impacts that come with them.

You’ll understand how such technologies can minimize uncertainty with data-driven compliance, its actionable information empowering you to prioritize measures based on actual findings, not hunches.

And you’ll free up your staff to work on your next big product instead of spending endless hours finding and reviewing public data reports — a necessary part of modern regulatory compliance…unless you have the right digital solutions.

Webinar Takeaways:

  • Effortlessly monitor the regulatory landscape, correct issues found in your corrective and preventive action (CAPA) and audit programs, and avoid negative consequences with a predictive compliance solution
  • Easily conduct proactive quantitative analysis that furthers your data literacy and minimizes uncertainty with built-in data-driven compliance — in the form of a quantitative score — to take the guesswork from your regulatory project planning and compliance activities
  • Save time and money when you eliminate unnecessary monitoring and reviewing of public data sources — the right AI and ML technology does this for you

Between the proliferation of regulations and increasing stakeholder expectations, you’re more vulnerable to compliance risks than ever before. This free webinar will show you how AI and ML can vastly enrich your quality and compliance risk management programs. Join us by registering today.

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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Kamal Biswas

President and COO, Xybion

Kamal Biswas, Xybion’s president and COO, is an acknowledged leader in the life sciences industry and has more than 20 years of experience in management consulting and the pharmaceutical business. Prior to Xybion, he was a partner and leader of the global life sciences practice at Infosys Consulting. Mr. Biswas also spent several years working with pharmaceutical companies to manage manufacturing and late-stage R&D functions at companies including Novartis and Ciba Geigy.

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Heidi Krueger

Director of Quality Assurance, Xybion

Heidi Krueger leads Xybion’s quality assurance practice. She has 30 years of experience in FDA- and EPA-regulated industries in quality management, auditing, good laboratory practices (GLP), quality control testing, validation, analytical chemistry and method development. During her career, Ms. Krueger was the quality assurance manager or director for four different companies, including the second-largest single-site testing laboratory in the U.S. She is a member of the Society of Quality Assurance, a member of and vice president of the board of directors of the Mid-Atlantic Region Society of Quality Assurance, and a member of the International Society for Pharmaceutical Engineering.

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Bob Friedman

Chief Technology Officer, Xybion

Bob Friedman has more than 25 years of experience in preclinical information systems at Xybion as a developer, development manager and chief solution architect. He has been an active member of the Clinical Data Interchange Standards Consortium’s (CDISC’s) Standard for Exchange of Nonclinical Data (SEND) consortium for 10 years as well as an active member in the Pharmaceutical Users Software Exchange (PhUSE)/FDA Industry Collaboration. Mr. Friedman previously worked for Synthes Orthopedics, NYU Medical Center and the New York State Department of Health.

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Joe Kalina

Director of Marketing, Xybion

Joe Kalina has over 10 years of marketing experience across 4 multinational brands in both B2B and B2C. He has launched new state-of-the-art products to the life sciences industry including Xybion Digital Pathology and COVAPP. Joe served as a key member of the Xybion investor relations team, providing go to market strategy during Xybion Digital’s initial public offering on the Toronto Stock Exchange Venture. He is certified globally by Google Ads, the International Advertising Bureau in Europe, and Google Europe, Middle East, and Africa.