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Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter- WEBINAR

Webinars - Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter- WEBINAR
Webinars

By : Compliance Online

Date : 2011

Location : United States US / Palo Alto

Video 01h 05m
Description :

This Medical device inspection webinar training will teach you A to Z of inspection starting with how to prepare to what to do during inspection, close-out interview, FDA’s scope, what documents to show and how to respond to the inspection.

Keywords :

Medical Device Inspection, FDA’s scope, Compliance Training, conference, event, Webinar

 Areas Covered in the Seminar:

 

  • How to prepare for an FDA inspection.
  • Development and contents of an SOP for FDA inspection.
  • Personnel training before inspection.
  • How to behave during an inspection.
  • Limitations of scope of inspection.
  • Response to investigation findings.
  • FDA guidance documents used by their inspectors.

 

Who Will Benefit:

 

This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • Executive/senior management
  • Regulatory management
  • QA management
  • Any personnel who may have direct interaction with FDA officials
  • Consultants
  • Quality system auditors

 

 

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?

The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!

 

Instructor Profile:


Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

Anatomy of a Medical Device Inspection From EIR to 483 to Warning Letter

Product Type : On Demand Webinar

Author : Jeff Kasoff

Video 01h 05m

Languages : English

Organizer : Compliance Online

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria