FDAnews Announces 15th Annual FDA Inspections Virtual Summit Nov. 17-18, 2020

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Hear essential expert insights from FDA officials and industry experts during this year’s most important inspections summit. Register today.



15th Annual FDA Inspections vSummit
An FDAnews Virtual Summit
Tuesday, Nov. 17-Wednesday, Nov. 18, 2020

Inspections are different amid this global pandemic, but what are the ways to best navigate them now?

There’s no one better to help guide one through these changes than FDA officials and the industry’s most experienced professionals. At the 15th Annual FDA Inspections vSummit on Nov. 17 and 18, experts from around the country will come together to share what they know about the current state of inspections. If one has been wondering how to make it through an upcoming inspection while coping with COVID-19, these sessions and panels are for you.

Attendees will spend this virtual summit with leaders in the drug and device industry going through everything needed to know to successfully navigate an inspection.

During these two days, one will hear from industry experts on timely topics like ensuring GMP inspection readiness, implementing the FDA’s capability maturity model, understanding cybersecurity developments, managing global supply chain issues, determining the future of inspections, managing virtual MDSAP inspections and medical device recalls. Don’t miss these conversations with:

  • Don Ashley, Director, CDER Compliance
  • Elizabeth Miller, Pharm.D., Assistant Commissioner Medical Products & Tobacco Operation Office of Regulatory Affairs, FDA
  • Francisco Vincenty, Program Manager for the Case for Quality, Office of Compliance, Center for Devices and Radiological Health, FDA
  • Kalah Auchincloss, Senior Vice President, Regulatory Compliance and Deputy General Counsel, Greenleaf Health
  • Sarah Barkow, Lead GxP External Engagement, Bristol Myers Squibb; former Lead Consumer Safety Officer and Acting Director, Manufacturing Quality Guidance and Policy Staff, CDER, FDA
  • Seth Carmody, VP, Regulatory Strategy, MedCrypt
  • David Chesney, Principal and General Manager, DL Chesney Consulting LLC
  • David Elder, Executive Vice President, Greenleaf Health
  • Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
  • Connie Hoy, Consultant, Hoy & Associates Regulatory Consulting, LLC
  • Paula Katz, Special Counsel, Covington & Burling
  • Julie Larsen, Principal, Director of Inspection Readiness, Teknica Inc.
  • Beverly Lorell, Senior Medical & Policy Advisor, King & Spalding
  • Steve Lynn, Principal Consultant/Owner, Lynn Consulting LLC
  • Steven Niedelman, Lead Quality Systems & Compliance Consultant, King & Spalding LLP
  • Melanie Power-Burns, Senior Vice President of Quality, Fresenius Kabi
  • Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health
  • Vicky Stoakes, President, IntegRx Inc; former Chemist, ACNA and Investigator, FDA’s Atlanta District Office Drug Cadre
  • Armin Torres, Principal, Bioteknica

There’s no more effective way to discover the intricacies of this new regulatory world than by mastering it with the industry’s top experts. Join them for sessions dedicated specifically to the interests of drug and devicemakers and get all the details needed to soar through an inspection.

Multi-attendee discounts available!
Significant tuition discounts are available for teams of two or more from the same company.

Virtual Conference Details:
15th Annual FDA Inspections vSummit:
An FDAnews Virtual Summit
Tuesday, Nov. 17-Wednesday, Nov. 18, 2020

Regular Pricing: $697

Easy Ways to Register:
Online: https://www.fdanews.com/fdainspectionssummit
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
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