FDAnews Announces CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman, Webinar Rebroadcast, April 10, 2014

CDRH has recently overhauled its Office of Compliance — what exactly has changed and what hasn’t? In this exclusive question-and-answer webinar rebroadcast, FDA veteran Steve Niedelman, lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, speaks with Steve Silverman, Director of CDRH’s Office of Compliance, to help device manufacturers understand all the changes.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) March 31, 2014

CDRH’s Office of Compliance Reorganization:
A “One-On-One” with Office Director Steve Silverman
**FDAnews Webinar Rebroadcast**
Feb. 5, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/CDRHreorganization

CDRH has recently overhauled its Office of Compliance — what exactly has changed and what hasn’t? What do teams need to know going forward in order to deal with the Office of Compliance? What does the OC expect from devicemakers?

Sign up now for this exclusive question-and-answer webinar with FDA veteran Steve Niedelman, lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, as he speaks with Steve Silverman, Director of CDRH’s Office of Compliance, to help device manufacturers understand all the changes.

They will discuss:

  •     How the reorganization will impact any pending business with the OC
  •     Whether or not manufacturers need to set up new contacts with regard to compliance issues
  •     What to expect from each new director and staff

With the recent reorganization of the Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH), the office will sharpen its focus on international inspections and audits on labeling.

The office has also replaced the office’s former four–division structure with five divisions, with each division containing a number of sub-branches. The divisions are as follows:

  •     Analysis and Program Operations (DAPO), which will handle establishment registration and listing, facility inspections, and supports recalls;
  •     Bioresearch Monitoring (DBM), which will provide oversight of clinical trials and coordinate inspections of regulated parties;
  •     International Compliance Operations (DICO), which will focus on issues relating to foreign device manufacturers, imports and exports, and also oversee an international audit program;
  •     Manufacturing and Quality (DMQ), which will focus on domestic enforcement activities and recalls related to device quality and safety, and reviews of premarket approval application manufacturing sections, site change supplements, and signals and complaints related to product quality; and
  •     Premarket and Labeling Compliance (DPLC), which will enforce requirements regarding premarket clearance and approval, labeling and advertising.

Who Will Benefit
Here’s a suggested list of potential participants:

  •     Regulatory Affairs
  •     Legal Counsel
  •     Compliance Officers
  •     Marketing Officers
  •     Management Personnel

Conference Details
CDRH’s Office of Compliance Reorganization:
A “One-On-One” with Office Director Steve Silverman
**FDAnews Webinar Rebroadcast**
Feb. 5, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/CDRHreorganization

Tuition
$467 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register
Online:     http://www.fdanews.com/CDRHreorganization
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.