Conference & Events
Event Details
FDA Inspections - Do's & Don'ts - Webinar By GlobalCompliancePanel
The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that your products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful inspection is being prepared to communicate how your quality systems assure this state of control.
Date: 27 June 2012 10:00 - 11:00
Event Subject(s):
Biosciences
Education
General
Venue
Online Training
1000 N West Street
DE
Suite 1200
Wilmington,DE
19801
United States of America
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Organiser Information
Organiser(s): GlobalCompliancePanel
Contact for Event Information
Name : Online Training
United States of America
Tel:
800-447-9407
Fax:
302-288-6884
Email:
webinars@globalcompliancepanel.com
Contact Useful link:
http://www.globalcompliancepanel.com
Additional Information
Speaker Information:
Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included quality management of laboratory assessment, site GMP lead auditor, FDA QSIT/Quality Management System manager, 5S coordinator, GMP trainer (annual, ongoing, new hire), OSHA regulations and Process Safety Management training, as well as internal and external public relations.
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Other information:
What does a successful inspection look like? First, zero observations but that depends on your level preparedness and how you handle and manage the inspection. This includes such factors as: timely delivery of documents, good interview skills, your ability to demonstrate controlled systems and self-confidence. Do you have what is needed to have that successful inspection?
The arrival of an investigator for an unscheduled inspection can be an intimidating experience. However, the inspection can be less traumatic if the site and its personnel are properly prepared for the inspection and the investigator. During this hour presentation, you will find out how to:
Prepare for the inspection,
Manage the activities of the inspection, the investigator and your inspection personnel,
Develop a system for an analysis of what happens after the inspection.
Why you should attend:
Recognize the purpose of the inspection
Anticipate what information the investigator can and will request
Learn how to properly communicate with the inspector
Know how to keep the inspection from being an “emotional” event.
Know what is expected of you and your company
Learn what not to say or not do during an inspection
Recognize your inspection responsibilities and vulnerabilities
Identify the internal support system of a successful inspection
Realize what steps you/your company should take to prepare for a successful inspection
Areas Covered in the Session:
Expectations of an audit
Why the FDA conducts inspections
Pre-planning and preparation activities
What to do when the investigator arrives
What documents to have ready and on hand
Assignments and responsibilities for the inspection
A review of Inspection Do's and Don'ts
The Opening and Close-out Sessions
Actions to take after the inspection is over
Who Will Benefit:
Site Quality Operations Managers
Quality Assurance and/or Compliance personnel
Plant Managers and Vice-Presidents of Quality
Manufacturing Superintendents and Managers
Individuals whose job knowledge and/or expertise may be required during an audit (Subject Matter Experts)
