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”
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”.
• 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
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.