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.
How Artificial Intelligence is Changing the Drug, Medical Device and Clinical Trials Industries
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.

How Artificial Intelligence is Changing the Drug, Medical Device and Clinical Trials Industries

Artificial Intelligence has already started to change healthcare. In April, the FDA permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. But that is just the beginning. In clinical trials, AI has been used to make patient enrollment more efficient. In drug and medical device manufacture, AI can be used to interpret big data sets to help ensure quality. In fact, manufacturers who do not integrate AI into their processes may find they’re falling behind or even becoming obsolete. Come listen to one of the experts in AI describe how the medical products industry is using AI and what the future holds.


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

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

Co-Chair Steve Niedelman will provide real-world scenarios for dealing with inspections for combination products. 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.


12:00 p.m.

Summit Adjournment


register

Preconference | Day 1 | Day 2

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