13th Annual FDA Inspections Summit

precon
8:00 a.m. – 9:00 a.m.
Registration and Continental Breakfast
9:00 a.m. – 9:10 a.m.
Opening Comments by Chairperson
9:10 a.m. – 10:00 a.m.
Ethical and Scientific Issues in Developing Deep Learning Systems in Medicine: More Like Drugs Than You Might Think
10:00 a.m. – 10:45 a.m.
Total Cost of Quality and Industry 4.0: The Bi-Modal Challenge Facing Quality Leaders Today
10:45 a.m. – 11:00 a.m.
Refreshment Break
11:00 a.m. – 12:00 p.m.
Panel Discussion: How to Manage a Combination Products Inspection
12:00 p.m. Summit Adjournment

8:00 a.m. – 9:00 a.m.

Registration and Continental Breakfast


9:00 a.m. – 9:10 a.m.

Opening Comments by Chairperson

Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations


9:10 a.m. – 10:00 a.m.

Ethical and Scientific Issues in Developing Deep Learning Systems in Medicine: More Like Drugs Than You Might Think

This session will compare the development of deep learning systems in medicine to the development new drugs. Building on prior work on the structure of clinical translation for new drugs (Kimmelman and London 2015) Professor London will argue that in both cases uncertainty about the structure of key causal systems necessitates prospective, empirical testing in well-controlled trials to assess claims of clinical utility. He will compare the demands to assess drugs in light of real world evidence to the importance of assessing the net effect on care from integrating deep learning systems into clinical practice.

Alex John London, Clara L. West Professor of Ethics and Philosophy and Director of the Center for Ethics and Policy, Carnegie Mellon University


10:00 a.m. – 10:45 a.m.

Total Cost of Quality and Industry 4.0: The Bi-Modal Challenge Facing Quality Leaders Today

As an FDA-regulated drug-manufacturing or device-maker, CRO or CDMO, your commitment to top quality goes without saying. You’re 100% up to date on the latest tools and techniques. But lowering costs without disrupting product quality, safety, efficacy, compliance and continuity, presents a major hurdle that may seem impossible to overcome; a problem that is compounded by the rise of 3D printing, automation, cloud computing and personalized medicine within manufacturing. In this session, Steve McCarthy, Sparta’s VP for Digital Innovation, demonstrates how digital technology is transforming quality management in companies like yours. You’ll discover:

  • Benefits and challenges of using cloud platforms and other digital technology in a Quality and/or GxP-regulated environment
  • Consequences of an inferior quality management system
  • Foundations of a superior quality management system
  • How to use digital technology — including cloud platforms — to augment your quality strategy
  • The GxP-regulated environment: Challenges and benefits of cloud platforms and other digital innovations
  • Cost-saving and value-add opportunities to help your company thrive

Steve McCarthy, Vice President of Digital Innovation, Sparta Systems; former VP of Quality Systems Shared Services, Johnson & Johnson


10:45 a.m. – 11:00 a.m.

Refreshment Break


11:00 a.m. – 12:00 p.m.

Panel Discussion: How to Manage a Combination Products Inspection

The FDA expects manufacturers to be able to demonstrate how they meet applicable cGMP and QSR requirements, and that they are properly documented. How does a manufacturer deal with inspections when product is developed and manufactured at multiple sites? How does EU MDR change the landscape? All this and more will be discussed in a panel that will summarize the experiences of combination product manufacturers and help provide a roadmap for what others can expect.

Moderator: Quynh Hoang, Consultant, FDA and Life Sciences, King & Spalding

Susan Neadle, Sr. Director, Global Value Chain Quality Design, Head, J&J Combination Products CoP, Johnson & Johnson

David Shore, Quality Director, IDM, Eli Lilly and Company

Anita Michael, Principal Consultant, PAREXEL Consulting


12:00 p.m.

Summit Adjournment


register

Preconference | Day 1 | Day 2

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