SQA Connect Lounge: Ethics and/or/versus Compliance
Session 1 - Good Clinical Practices
This online webinar will be given via Zoom.
Presented by: Kamila Novak, KAN Consulting MON. I.K.E., Judy Zahora, KAN Tyra Biosciences
Webinar Category: Compliance
Regulatory Area of Interest: GCP
Description:
This is part of a series of Connect Lounges focusing on Ethics and/or/versus Compliance. More information about future topics can be found below.
No matter how much we wish ethics and compliance were always aligned, every now and then we encounter grey zones and dilemmas, and the way forward is not so clear and obvious. This Connect Lounge series will explore case studies from various GXP areas (GCP, GLP, GMP, GVP, AI and overarching). Moderators will discuss 2-3 case studies per Lounge, and will ask attendees four basic questions:
- Is there a potential compliance issue?
- Is there a potential ethical issue?
- How would you analyze the root cause(s)?
- What would you do in this situation?
Attendees will also be encouraged to share their own experiences with challenging situations.
To create a safe space for discussion, these Lounges will not be recorded.
RQAP Re-registration units approved: TBD