FDAnews Announces the 13th Annual FDA Inspections Summit – New Clinical Track, Oct. 23-25, 2018, Bethesda, MD

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FDAnews

Jul 31, 2018, 00:00 ET

FALLS CHURCH, Va. (PRWEB) July 31, 2018 -- 13th Annual FDA Inspections Summit
**Presented by FDAnews**
Oct. 23-25, 2018 – Bethesda, MD
http://www.fdanews.com/fdainspectionssummit

Clinical trials face their own special compliance issues. Why shouldn’t they have their own compliance training?

Mark the calendar for the first-ever FDA Inspections Summit with special sessions exclusively for clinical trial professionals. Attendees will discover:

  • What’s up with BIMO? Latest news and initiatives coming out of the Office of Bioresearch Monitoring Operations.
  • Best practices in clinical trial inspection readiness, focusing on the essential steps you must take to prepare for your next inspection. What warning can clinical trial professionals expect from the FDA? Why is a facility being singled out? What will the inspectors focus on? What are clinical trial operators rights during the inspection? What’s the right (and wrong!) way to respond to inspection findings? And what are the most common missteps that clinical sites make during inspections?
  • The 10 best and worst things to do when the investigators are on site.

Attendees will want to be on hand for the general sessions too, as top FDAers range across subjects ranging from “Integrated Quality Assessment” to a rare look inside the head of an FDA investigator before, during and after the inspection.

Arrive the afternoon before and take part in a special pre-conference afternoon workshop that brings attendees up to date on the changeover to ICH E6 (R2) and a risk-assessment-based compliance regimen. Attendees will discover what the new guidelines require; a step-by-step plan to establish a program; conducting risk assessment at both system and clinical trial levels; risk mitigation and reporting strategies and sidestepping common pitfalls.

For clinical trial professionals, it’s the must-attend event of the year.
Conference Details
13th Annual FDA Inspections Summit:
**Presented by FDAnews**
Oct. 23-25, 2018 – Bethesda, MD
http://www.fdanews.com/fdainspectionssummit

Tuition:
Early Bird Registration (until Sept. 21, 2018): Complete Summit $1,797
Regular Registration (Sept. 22, 2018 on): Complete Summit $1,997
Additional pricing options are available online.

Easy Ways to Register:
Online:     http://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

Michelle Butler, FDAnews, http://www.fdanews.com, +1 703-538-7660, [email protected]