Webinar On FDA Inspection Readiness
Instructor:
Pam Dellea Giltner
Product ID: 705974
- Duration: 90 Min
Why Should You Attend:
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?
This presentation will instruct the participant on how they can contribute to ensure Inspection Ready clinical studies.
Areas Covered in the Webinar:
The webinar 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 – Definition and understanding
- What do the regulations mean?
- When do preparations start?
- Company Quality Systems
- Defining Metrics
- Use of Tools and Processes
- Guidance Documents available
- Managing company performance
Free Materials:
- Reference documents
- Rule documents or guidance
- Checklist
- Articles
Who Will Benefit:
- Clinical Operations Directors
- Regulatory Affairs Professionals
- Clinical Operations personnel
- Quality Managers
- GXP
- Consultants
Pam Dellea Giltner
CCEO, PDG Clinical Consulting LLC
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.
She has held positions in both pharmaceutical and CRO companies including GCP Auditor, Project Manager, Clinical Research Associate, and Trial Manager.
Currently she is Chairman of the ACRP CCRA Examination Committee and has been a certified CCRA since 2009.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
