Guess Who’s Knocking at Your Door: Assuring Inspection Success!

First impressions can make or break you. 

Manufactures rarely get a second chance to make a first impression during an FDA inspection. It is critical that firms be inspection ready, understand FDA’s authority and their expectations, as well as ensure their firm is prepared to be responsive to FDA’s requests. 

On Thursday, May 28 at 1:30 PM EST/10:30 AM PST, industry veteran and former Chief Operating Officer of the Office of Regulatory Affairs, Steven Niedelman, hosted a comprehensive webinar with Govzilla on Assuring Inspection Success. Mr. Niedelman discussed preparing your organization for inspection success and how to manage the stress of an actual inspection. He also touched on the “Do’s and Don’ts” of inspection awareness and how to navigate and respond to questions that may seem daunting while demonstrating the culture of quality at your firm and finished up by discussing how to avoid FDA leaving with the wrong impression.

Download the slide deck and video here!

What you will learn:

  • Overview of FDA’s Inspection Program
  • FDA’s Authority to Inspect
  • What to Expect During an Inspection
  • How to Prepare Your Organization for Inspection Success
  • Hot to Best Manage the Stress of an Actual Inspection
  • The Do’s and Don’ts During an Inspection

Who Will Benefit? 

This session will be valuable to quality, regulatory, compliance, and management personnel in FDA-regulated industries who want insight on how to be prepared for an FDA Inspection.

To download the slides, click here!

About the Presenter

Steven Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters involving industries regulated by the U.S. Food and Drug Administration. He provides strategic advice, insight, and guidance to the medical device, pharmaceutical, biologics, and food industries to ensure compliance with the requirements of the Federal Food, Drug, and Cosmetic Act.

He joins King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its health care group. Previously, he was executive vice president of Quintiles Consulting.

Mr. Niedelman consults with manufacturers, importers, new product developers, as well as with firms involved in or facing enforcement actions. He helps firms develop corrective action plans so their business needs are properly balanced with regulatory requirements in order to achieve compliance without compromising objectives.

He provides training and guidance to industry professionals on all FDA requirements, including quality systems requirements, inspection preparedness, post-market obligations, and to executives about their management responsibilities as well as FDA’s expectations.

Mr. Niedelman retired from the Food and Drug Administration in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA’s regulatory policies by directly overseeing offices at the headquarters of the Office of Regulatory Affairs (ORA), including the Office of Regional Operations, Office of Enforcement, and Office of Criminal Investigations. Additionally, Mr. Niedelman assisted in the day-to-day management of FDA’s nearly 3,400 field staff responsible for investigative and laboratory operations.

While at ORA, Mr. Niedelman served as the principal liaison to the Center for Devices and Radiological Health, and was a member of the Global Harmonization Task Force (GHTF) Steering Committee, FDA/Medical Device Industry Grassroots Initiative Steering Committee, and the CDRH Post Market Initiative Steering Committee. He also served on the Steering Committee to the Pharmaceutical “cGMP for the 21st Century” initiative as well as the Counterfeit Drug Task Force.

Prior to joining the Office of the Associate Commissioner, he was the Director and Deputy Director of FDA’s Office of Enforcement, where he was responsible for oversight and consistency of compliance policy, enforcement, and recall activities to ensure fair implementation by FDA’s five product centers. During his tenure, Mr. Niedelman presided as the Chairman of FDA’s Compliance Policy Council. He currently participates as a member of the Medical Devices Committee at the Food and Drug Law Institute and as a member of the Editorial Review Board for FDA News GMP publications directed at the pharmaceutical and medical device industries. Mr. Niedelman has also served as Vice President of the FDA Alumnae Association.

Before joining the Office of Enforcement, Mr. Niedelman spent nearly 24 years throughout the Office of Compliance at the Center for Devices and Radiological Health (CDRH) in a number of management positions. During those nearly 24 years at CDRH he was responsible for implementing many of the newly created statutory requirements and drafting and shaping many of the regulations and policies affecting the sale, distribution, and promotion of medical devices. He began his FDA career in 1972 as an Investigator in FDA’s New York District Office.

Download the slide deck and video here! 

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