Thursday, September 19
7:00 a.m. – 5:30 p.m.
Registration Open
7:00 a.m. – 8:30 a.m.
Continental Breakfast
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7:15 a.m. – 8:15 a.m.
Breakfast Session: The Intersection Between Mindfulness and Data Integrity (Sponsored by Ultragenyx Pharmaceutical)
Moderator: Peter E. Baker, MS, Vice President, Green Mountain Quality Assurance and formerly with the FDA
Data integrity issues, whether unintentional human error or intentional, will never disappear completely. People are complex and driven by many motivations. However, the industry can respond in a more holistic way to both understand and address these issues. Understanding the human element is a critical piece to address Data Integrity lapses. Mindfulness is a tool that can help you and your teams create capacity and focused awareness. By introducing the ability to pause during stressful situations, we can achieve thoughtful responses versus stress or fear-induced reactions. Can we expand our line of sight to include mindfulness and meditation in addition to the usual tactile tools already in place for ensuring good decision making with regard to data integrity?
This breakfast session will explore the neuroscience of human behavior, mindfulness, and the connection to data integrity. This session will include a presentation, a short mindfulness practice, and then end with Q&A
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7:15 a.m. – 7:45 a.m.
Amy L. McLaren, Senior Director, Quality and Compliance, Ultragenyx Pharmaceutical
Julie C. Maurhoff, CQA, Senior Director, GxP Compliance, Ultragenyx Pharmaceutical
7:45 a.m. – 7:55 a.m.
Practice Exercise
7:55 a.m. – 8:15 a.m.
Questions and Answers/Discussion
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8:30 a.m. – 10:00 a.m.
P3: How Do You Apply Data Integrity Concepts Over the Lifecycle of a Product?
Moderator: Jackie Veivia-Panter, Senior Director, Quality Systems and Compliance, Legend Biotech
Just as industry and regulators have discussed phase appropriate GMPs throughout the years, are there phase appropriate Data Integrity requirements? What does this mean to your Data Integrity Program? During this session, we will hear from a consultant and a U.S. FDA representative with their perspectives on what this means, how to apply them, and challenges you may face.
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8:30 a.m. – 9:00 a.m.
Assuring Data Integrity in Drug Applications Submissions: Regulatory Expectation Challenges and Case Study
Aditi S. Thakur, MS, Acting Quality Assessment Lead, Office of Pharmaceutical Quality, CDER, FDA
9:00 a.m. – 9:30 a.m.
The Tricky Transition from Development to Commercial Manufacturing: Compliance and Quality Risks
Tom Cosgrove, JD, Partner, Covington & Burling LLP and formerly with the FDA
9:30 a.m. – 10:00 a.m.
Panel Discussion with Speakers and Additional Panelists
Peter E. Baker, MS, Vice President, Green Mountain Quality Assurance and formerly with the FDA
Els Poff, Executive Director, Data Integrity CoE, Merck & Co., Inc.
Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, FDA
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9:45 a.m. – 4:00 p.m.
Exhibit Area Open
10:00 a.m. – 10:30 a.m.
Refreshment Break in Exhibit Area
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10:30 a.m. – 12:00 p.m.
P4: Quality Culture: What is all the Buzz About?
Moderator: Peter E. Baker, MS, Vice President, Green Mountain Quality Assurance and formerly with the FDA
Many of the new guidance and regulatory communications have specifically called out how important it is to have a good Quality Culture as the basis for Data Integrity. Join us for understanding why this is so important and how it is measured. In addition, a GlaxoSmithKline representative will present how they have effectively influenced their quality culture to support a robust Data Integrity Program.
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10:30 a.m. – 11:00 a.m.
Does Quality Culture Matter? A Data-Based Analysis
Thomas Friedli, Director, Institute of Technology Management, University of St. Gallen
11:00 a.m. – 11:30 a.m.
Integrating Human Factors into our Data Integrity Strategy
Ervin Rodriguez, Vice President, Quality Systems, Pharmaceutical Supply Chain, GlaxoSmithKline
11:30 a.m. – 12:00 p.m.
Panel Discussion with Speakers and Additional Panelists
Cylia Chen-Ooi, MS, Director Quality External Affairs, Amgen Inc.
Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, FDA
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12:00 p.m. – 1:00 p.m.
Networking Lunch
1:00 p.m. – 2:15 p.m.
Concurrent Breakouts
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Breakout 1: Organizational Failure: Impact of Management and Employees Not Understanding Data Integrity Concepts
Moderator: Ronald F. Tetzlaff, PhD, Corporate Vice President, PAREXEL International
This session will explore examples of management failure to prevent and detect data integrity issues, how regulators are able to detect significant data integrity issues, and how to fix gaps.
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Speaker:
David M. Churchward, MSc, Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector), MHRA, UK
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Breakout 2: Quality Culture: Milestones and Metrics in Support of Data Integrity
Moderator: Kir Henrici, CEO, The Henrici Group
This breakout will explore the insights, challenges, and big wins of a quality culture and data Integrity Initiative.
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Speakers:
Ronald D. Gunn, MS, MBA, Chief Operating Officer, Kaleo, Inc.
Gregory L. Tewalt, PhD, Director Quality and Compliance, Kaleo, Inc.
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2:15 p.m. – 2:30 p.m.
Break
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2:30 p.m. – 3:30 p.m.
Group Discussion: Report Out
Moderators: Jackie Veivia-Panter, Senior Director, Quality Systems and Compliance, Legend Biotech
Learn from all of the case studies! Each breakout session will present a case, challenges identified, and possible solutions.
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3:30 p.m. – 4:00 p.m.
Refreshment Break in Exhibit Area
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4:00 p.m. – 5:30 p.m.
P5: Big Data Integrity
Moderator: Kir Henrici, CEO, The Henrici Group
This session invites data integrity futurists to explore the 21st century big data boom; taking a glimpse at technological innovations and intelligence trends and the ensuing paradox of challenges and rewards facing stewards of Data Integrity. Participants will have the opportunity to exchange ideas during the Q&A following speaker presentations.
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4:00 p.m. – 4:30 p.m.
Big Data: The Not-so-Basics
Mark A. DiMartino, MS, Director Quality Data Sciences, Amgen Inc.
4:30 p.m. – 5:00 p.m.
Big Data Integrity
Peter E. Baker, MS, Vice President, Green Mountain Quality Assurance and formerly with the FDA
5:00 p.m. – 5:30 p.m.
Panel Discussion with Speakers and Additional Panelist
Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, FDA
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5:30 p.m.
Closing Remarks from Conference Co-Chair
Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, FDA