Boston Professional Events List


Do's and Don'ts during FDA Inspections


Date
May 17, 2019 - 03:00 PM - 04:00 PM
Organizer
WCS
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,
FL,
US,
ZIP: 33021
Phone: 844-267-7299 | 954-947-5671  

Overview

This webinar will provide useful and practical information for you to consider and implement for your organization, significantly contributing to hosting successful FDA inspections. At the end of the webinar, you will learn what and how to change and improve your ways of preparing for and getting ready for an FDA inspection.


 

Objectives of the Presentation

  • How to prepare for an FDA inspection

  • Development and content of an SOP for FDA inspection

  • Personnel training before inspection

  • How to behave during an inspection

  • What to show FDA during an inspection

  • Proper Post-inspection Follow-up

  • Limitations and scope of inspection

  • Response to investigation findings

  • FDA guidance documents used by their inspectors


Why Should you Attend


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! This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.



Who will Benefit

  • Internal / External Auditors

  • Regulatory Management

  • Quality Assurance Professionals

  • Consultants

  • Sales/Marketing Management

  • Senior and mid-level Management

  • QA/QC

  • Compliance

  • Regulatory Affairs

  • Operations and Manufacturing



Speaker Details


Instructor Profile

Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. 

 Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671  
Don't wait. Register TODAY or  Email  US [email protected]


Event Categories
Keywords: pharmaceutical




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