FDAnews Announces -- The 16th Annual FDA Inspections vSummit Nov. 16-17, 2021

Hear from FDA and industry VIPs at the 16h Annual Inspections vSummit's Medical Devices track. Register today.

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Oct 22, 2021, 18:00 ET

FALLS CHURCH, Va., Oct. 22, 2021 /PRNewswire-PRWeb/ -- What will an FDA inspection look like in 2022? How does one prepare for the FDA's draft rule on harmonizing the Quality System Regulation with the ISO 13485:2016? What is the best response to FDA enforcement actions?

If one is developing, manufacturing or marketing medical devices, one needs to be able to resolve these critical questions. Find the essential answers and more at the upcoming 16th Annual FDA Inspections vSummit. Join the track dedicated to medical devices for insights from current and former FDA officials, along with other seasoned industry leaders.

During the summit's comprehensive, interactive and expert-led sessions, attendees will jump into the most relevant medical device topics of the moment. Over this two-day vSummit, connect with engaged colleagues and learn from knowledgeable experts. Here's some of what attendees will experience:

  • At the start of this program, discover the FDA's expectations for future inspections from Elizabeth Miller, Pharm.D., Assistant Commissioner Medical Products & Tobacco Operation Office of Regulatory Affairs, FDA.
  • Follow that timely conversation with discussions about the agency's new inspection affairs council and the adjusted inspection approaches that will arise out of a harmonized QSR.
  • On the second day, get straightforward details on how to manage an inspection — and what to avoid — from Steve Niedelman, former FDA Deputy Associate Commissioner for Regulatory Operations.
  • Dig deeply into the FDA's use of remote regulatory assessments, explore best practices in formulating responses to FDA enforcement actions and discuss the benefits of artificial intelligence in both diagnosis and treatment.

There have been tremendous changes to the FDA's inspections process since the start of the COVID-19 pandemic and there are only more to come. Learn the lessons one needs to navigate the ever-changing world of inspections, whether that means a return to on-site inspections or a continued integration of remote processes.

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

Virtual Workshop Details:
16th Annual FDA Inspections vSummit
An FDAnews Virtual Summit
Tuesday-Wednesday, Nov. 16-17, 2021
https://wcg.swoogo.com/fda-inspections-summit

Tuition:
Single Attendee - $597.00
Group of 2-4 Attendees (Save 10%) - $527.00
Group of 5-6 Attendees (Save 15%) - $492.00
Group of 7-9 Attendees (Save 20%) - $458.00
Group of 10+ Attendees (Save 25%) - $423.00

Easy Ways to Register:
Online: https://wcg.swoogo.com/fda-inspections-summit
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

Media Contact

Michelle Butler, FDAnews, 703.538.7600, [email protected]

SOURCE FDAnews