3 Hours Virtual Seminar: FDA Inspections- What Regulations Expect and How to Prepare

Elisa Bovee

Starting at

$599


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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.

Additional benefits of this class include discussion of:
  • FDA authority and process including 483s, Warning Letters, recalls, and other potential actions
  • The FDA inspection process and approach
  • Device Master Records requirements
  • The use of a mock audit and outside certifying audit
  • Required documentation, format, and archive How to respond to inspection and audit results
  • Parallel process from the EMEA, TGA, PMDA, and other international regulatory agencies

Course Objective

Upon completing this course participants should:

  • 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


Course Outline

Introduction

  • 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
  • Common 483s and warnings
  • FDA inspection questions
  • Documentation
  • CAPA: corrective and preventive actions
  • OOS: "Out of Specification" prevention and response
Legal Issues
  • Executive responsibility and vulnerability
  • Management review
  • Staff training
  • FDA authority and powers
FDA Inspection Checklist: Do's and Do'ts
  • Documentation preparations
  • Hosting investigators
  • What not to say
  • Key roles and players
  • Responses to the inspections
  • Initial response
  • Challenge
  • Dispute
Emerging Issues
  • Part 11 Signatures and records: latest interpretation, 483s
  • Signature authentication
  • Archiving
  • Audit trails
MOCK AUDITs
  • FDA inspection questions
  • Documentation
  • CAPA: corrective and preventive actions
  • OOS: Out of specification: prevention and response
Uses and Limits of Internal Audits
  • Fear factor
  • Inside versus outside
  • Checklist
  • A model of successful audits
  • A model for FDA inspections


Target Audience

  • This is a practical webinar 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.
  • Quality Assurance Managers and Supervisors
  • Validation managers and Supervisors
  • Engineering Managers and Supervisors
  • Regulatory Affairs Managers and Supervisors
  • Manufacturing and Operations managers and Supervisors

Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Elisa Bovee,

Elisa Bovee has been working in the healthcare environment advocating for patients through education and clinical guidance. With a degree in Occupational Therapy she has managed a national operations team performing audits and analysis across the US for skilled nursing home providers.

Her expertise includes compliance programs, reimbursement and regulatory, development of education programs, skilled documentation for nursing and therapy and managing claims through the development request and denial phases.

Elisa has presented programs targeting all interdisciplinary groups throughout the country for audiences seeking guidance and clarity on a multitude of regulatory and clinical topics. Additionally, she has written and contributed to articles for national trade publications.


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