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FDA Inspections: Developing Effective Readiness Strategies

FDA Inspections: Developing Effective Readiness Strategies


CourseDirector Course Director: Jackelyn Rodriguez

CourseCost Course Cost | Ubicacion1 Course Location |  Date Course Date

Costa Rica | Oct 23 - 24

$1250.00 Regular Registration
Doubletree by Hilton Cariari San Jose-Costa Rica
San Antonio de Belén, Ciudad Cariari 
www.CariariSanJose.DoubleTree.com

Amsterdam | November 6 - 7

$1450.00 Regular Registration / $1300.00 Early Bird (30 Days in Advance)
DoubleTree by Hilton Hotel Amsterdam - NDSM Wharf 
NDSM-Plein 28
Amsterdam, 1033 WB
Netherlands

China | December 4 - 5

$1450.00 Regular Registration / $1300.00 Early Bird (30 Days in Advance)
Hilton Shanghai Hotel 
No 250 Hua Shan Road
Shanghai, 200040

CourseBrochure Aditional Course List: Click here

Course Description

FDA Inspections: Developing Effective FDA Readiness Strategies
Course Description - Course runs 9:00 to 5:00 (Breakfast & Lunch Included)

This course is designed to provide participants with an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in pharmaceutical, biologics, and device facilities. It is intended to provide a framework for FDA lnspectional Readiness activities; it will focus on creating a plan will cover “High Risk” areas of likely interest to the FDA during the next expected FDA inspection such as:

  • FDA authority and process including 483s, Warning Letters, recalls, and other potential actions
    The FDA inspection process and approach
  • Review the effectiveness of previous FDA 483 observations and associated corrective actions
  • Learn about the “High Risk CAPAs”
  • MDRs and High Risk Complaints, Recalls: what is FDA looking for?
  • Identifying and prioritizing the issues that a company should consider areas likely to be investigated during the inspection
  • Identify Key Roles and Responsibilities
  • Top Readiness Activities and progress tracking
  • Record remediatio
  • SME preparedness
  • Required documentation, format, and archive
  • How to respond to inspection results
  • Learn how to perform Mock FDA SME Interviews

Who Should Attend

This is a practical, hands-on course designed to provide pharmaceutical, biopharmaceutical, biologics and medical device professionals with the information and tools they require to prepare for and manage an FDA inspection. The course is ideal for Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance.

Agenda

Course Agenda

Introduction

  • Participant goals, issues and questions: a flexible framework to assure that everyone leaves with the information they need
  • FDA Inspections: authority, guidelines, internal agency controls
  • Strategies for copies with FDA inspections

The Inspection Process

  • Systems and traditional inspection approaches
  • Establishing clear SOPs and policies
  • Managing the process
  • Device issues: engineering, quality control, and the Device Master Record (DMR)
  • Common 483s and warnings

Interactive group exercise:

Review of case study

Learn how to perform Mock FDA SME Interviews

  • MOCK AUDIT (workshop): Case Study of a Manufacturing Facility Inspection: Systems Inspection
  • FDA inspection questions
  • Documentation
  • CAPA: corrective and preventive actions
  • Complaint Handling investigations
  • Using QSR compliance trackers
  • Developing Storyboards
Interactive group exercise:

Develop Storyboard and Executive Summary: This phase involves the development of a storyboard and/or executive summary to aid in the explanation of complex issues.

FDA Inspection Checklist: Do's and Don'ts

  • Documentation preparations
  • Hosting investigators
  • What not to say
  • Key roles and players
  • Responses to the inspections

           o Initial response

           o Challenge

           o Dispute

  • Other emerging 483 issues

Learning Objectives

The course is designed to meet the objectives of preparing for – and surviving – an FDA inspection. Upon completion of the course you will:

  • Understand the guidelines, philosophy and practical approach of the FDA to inspections and visits
  • Understand the new FDA "systems approach" to inspections (QSIT), and the differences from the traditional "issues" approach
  • Develop strategies for preparing for and coping with FDA inspections
  • Plan for a self-audit in anticipation of FDA inspections
  • Have resources for reference and update

Who Should Attend

This is a practical, hands-on course designed to provide pharmaceutical, biopharmaceutical, biologics and medical device professionals with the information and tools they require to prepare for and manage an FDA inspection. The course is ideal for Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance.

For more information, click HERE
All of course can be delivered on-site and can be fully customizable

REGISTER HERE

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