FDA Inspection Readiness

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Listen to Pam Dellea-Giltner, who is a CEO and a principal auditor of PDG Clinical Consulting LLC. She has over 30 years of experience in all aspects of Clinical Research/Operations"

What it means to be “Inspection Ready”

Description

What does it mean to be “Inspection Ready”?  Are your clinical trials ready at any time for an agency or sponsor inspection?  What would you do if the FDA showed up tomorrow to inspect your study?  

The FDA and other global regulatory agencies can always show up at your door for an inspection without prior notification.  Are your clinical files organized, can documents be found easily if requested, are all essential documents in the eTMF, would your company pass inspection?   

This webinar will show you what it means to be “Inspection Ready” and how a Quality System in place at your company will ensure ongoing quality measures to be ready at any time for an audit, review by a Sponsor or any regulatory agency inspection.

Why should you attend:

This presentation will instruct the participant on how they can contribute to ensure Inspection Ready clinical studies.  

It will begin with a regulatory overview of what does inspection readiness mean.  How a quality system can assist with the ongoing quality and processes so that clinical trial essential documents are up to date.  Finally, Best Practices for creating, implementing and maintaining tools to ensure the clinical trial files are always “Inspection Ready”.

Areas Covered

•          Inspection Ready - what do the regulations mean?
•          Company Quality Systems 
•          Defining Metrics
•          Use of Tools and Processes
•          Managing company performance

Who will Benefit

•          Clinical Operations Directors
•          Regulatory Affairs professionals
•          Clinical Operations personnel
•          Quality Managers
•          GxP
•          Consultants

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Pam Dellea-Giltner

Pam Dellea-Giltner is CEO and principal auditor of PDG Clinical Consulting LLC.  She has over 30 years of experience in all aspects of Clinical Research/Operations.  Experience includes Quality Assurance/GCPs, Pre-Inspection Readiness/Audit Reponses, Project Management, Phase I-IV, post marketing and epidemiology studies, Study Management, Vendor/CRO Set up and management.  
Positions in both pharmaceutical and CRO companies included Auditor, Project Manager, Clinical Research Associate, and Trial Manager. 
Currently she is vice-chairman of the ACRP CCRA Examination Committee and has been a certified CCRA since 2009. 

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