FDAnews Announces — Domestic Inspections and Risk Assessment: What’s the Same and What’s Different with the FDA’s Resumed Operations? Webinar Sept. 24, 2020

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Get prepared for the next on-site or remote review now that the FDA has resumed inspections. Webinar provides expert tips.

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WCG FDAnews

Domestic Inspections and Risk Assessment:
What’s the Same and What’s Different with the FDA’s Resumed Operations?
An FDAnews Webinar
Thursday, Sept. 24, 2020, 1:30 p.m.-3:00 p.m. EDT
https://www.fdanews.com/domesticinspections

Inspection timelines have been thrown for a loop because of COVID-19. How exactly will sites move forward with the FDA?

The FDA stated in July that it would resume certain drug and device manufacturer domestic inspections and this webinar can help teams prepare.

FDA inspections expert Kalah Auchincloss will share how assessments are proceeding and what criteria the FDA is using to determine which sites are inspected. Through Auchincloss’ experienced perspective, attendees will gain insights into how to prepare for an on-site inspection, from extended records requests to appropriate personnel access. We’ll also consider how the FDA is deciding on remote inspections and ways to equip your team for this method of assessment.

During this webinar, we will cover:

● FDA Criteria for In-Person Inspections
     a. Safety and the COVID-19 Advisory Rating system
● Alternatives to On-Site Inspections
     a. Records requests, including access to electronic databases, screen shots,
         live-video functions or long-running documents
     b. Remote and hybrid assessments
     c. Appropriate personnel access
● Preparation for FDA Inspections
     a. Gaining clarity on domestic inspections criteria
     b. Standard approaches to 704(a) requests
● The Likelihood of Foreign Inspections Resuming
     a. Mutual recognition agreements (MRA)
     b. Pharmaceutical inspection co-operation schemes (PIC/S)

Whether a site is chosen for an on-site inspection, will go through a remote review or is awaiting assessment, teams need to be prepared. Let us help ensure one’s team is ready for whatever interactions with the FDA come next.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538 7600 globally to learn about our special multisite discount.

Domestic Inspections and Risk Assessment:
What’s the Same and What’s Different with the FDA’s Resumed Operations?
An FDAnews Webinar
Thursday, Sept. 24, 2020, 1:30 p.m.-3:00 p.m. EDT
https://www.fdanews.com/domesticinspections

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/domesticinspections
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
FDAnews
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