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"Oops – we have a problem!" Part 2.
Webinar Registration Form
3-Minute Participant Survey
Required for participation in:
"Oops – we have a problem!"
Part 2:
Root Cause Analysis (RCA), CAPA,
Effectiveness Check
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Your role:
Clinical Research Associates (e.g., Central Monitoring Associates)
Sponsor and Service Providers clinical staff
Project Managers / Clinical Trial Managers
QA staff
Clinical Investigators, Study Coordinators and other Investigator site staff
Administrative / Support function
Your custom variant
Which of the following situations have you encountered in your work?
You may select multiple
An inspection/audit came up and we were not fully prepared
It was difficult to locate up-to-date and complete documentation
Team members had different interpretations of how things should be done
Internal SOPs existed but did not work in practice
The inspection was completed but resulted in major findings
We haven’t experienced any issues
Your custom variant
*Select one or more options
Which types of support would be most valuable for your team?
You may select multiple
External assessment of our quality system (independent audit)
Preparation for an upcoming inspection (checklists, dry-run, risk analysis)
Support in redesigning or optimizing the QMS (diagnostic, consulting)
E6(R3) transition support (compliance gap assessment and adaptation plan)
Training for key personnel involved in audits and inspections
None of the above
Your custom variant
*Select one or more options
Which topic is most relevant to you right now (for a webinar, consultation, or training)?
Preparing for an audit with no prior team experience
Documentation issues: how to detect and resolve noncompliance before an inspection
Responding to findings: how to analyze typical failures and act effectively
Oversight of vendors and investigational sites: quality challenges and solutions
Implementing GCP E6(R3): what exactly needs to change
Building a functional QMS (beyond formal procedures)
None of these topics are relevant
Your custom variant
*Select one or more options
Which services might be relevant to you in the next 3–6 months?
Internal audit conducted by an external expert team
Inspection readiness assessment (risk analysis, checklists, dry-run)
Consulting for QMS revision or optimization
Transition support for E6(R3) (gap assessment, adaptation roadmap)
Training for staff involved in audits and inspections
We are not planning to involve external support at this time
Your custom variant
*Select one or more options
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