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

·3 min read

Hear from FDA and industry VIPs to get the information one needs at the FDA Inspections vSummit's Drugs/Biologics track. Register today.

FALLS CHURCH, Va., Oct. 27, 2021 /PRNewswire-PRWeb/ -- 16th Annual FDA Inspections vSummit
An FDAnews Virtual Summit
Tuesday-Wednesday, Nov. 16-17, 2021
https://wcg.swoogo.com/fda-inspections-summit

What will an FDA inspection will look like in 2022? What are the remote tools the FDA is using? What is the best way to communicate with the FDA to support a smooth, quick review?

The 16th Annual FDA Inspections vSummit on Nov. 16 and 17 will cover these essential topics and more, all informed by the expert perspectives of the speakers and moderators. With a track specifically dedicated to drug and biologics issues, this virtual summit will ensure attendees are ready for an inspection, whether it's virtual or in-person.

At the start of the event, Elizabeth Miller, Pharm.D., Assistant Commissioner Medical Products & Tobacco Operation Office of Regulatory Affairs at the FDA, will share her insights into the current state of the FDA and what she expects to see during the coming year.

Then, one will get details on the remote tools the FDA is using to augment or replace in-person inspections. While covering the differences between remote-inspection steps and hints for whether one will experience a virtual or in-person inspection, attendees will hear from:

  • Cynthia Schnedar, principal, regulatory compliance, Greenleaf Health, Inc.

  • Kalah Auchincloss, executive vice president, Greenleaf Health, Inc., former deputy chief of staff for two FDA Commissioners

  • Dan Barreto, president/owner, PharmQ Global Consulting, LLC, former FDA investigator

  • David Chesney, principal and general manager, DL Chesney Consulting, Inc., former FDA district director in San Francisco

  • Jack Garvey, managing partner, Compliance Architects

Later in the day, discover ways to ensure the manufacturing facility is ready for evaluation and narrow down the risk areas that could require special attention with Robert Rhoades, managing partner of Validant, and Steven Lynn, executive vice president of pharmaceuticals at Regulatory Compliance Associates Inc.

On the second day, one will get a detailed rundown of the do's and don'ts of an inspection from former FDA investigators, shared by David Elder, principal of Greenleaf Health, Inc., followed by a breakdown of communication tips for expediting a review from Cathy Burgess, partner at Alston & Bird LLP, and Paula Katz, of counsel at Covington & Burling LLP.

Then hear from Don Ashley, director at the Office of Compliance CDER at the FDA, about the latest agency trends, including the impact of COVID-19 on operations and updated manufacturing guidance.

There have been serious shifts to the FDA's inspection process throughout the global health crisis — and changes continue to come, including a likely return to more typical practices. Industry experts are coming together to share their insights on how FDA inspections will look going forward, along with a framework for what one can do to prepare.

Don't miss out on this opportunity to discover essential tactics and tips from seasoned experts on making one's way through an inspection.

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, mbutler@wcgclinical.com

SOURCE FDAnews

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