DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.
We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
DarshanTalks Podcast
Fixing Congruency Reviews in 8 Minutes
In this episode, Istvan Fekete joins us to discuss the intricacies of Congruency Reviews. We will explore the common mistakes individuals may encounter during these reviews and examine effective strategies for handling these errors. Additionally, we will delve into the processes that can be implemented to mitigate risks associated with congruency reviews. The discussion will also cover the potential benefits of involving third-party to ensure the accuracy and integrity of the review process.
Points Discussed:
•What are the biggest mistakes made in Congruency Reviews?
•What would a CAPA consist of?
•Do institutions want to allocate funds for additional quality checks?
•Do contracts need IRB congruency checks?
•Who should do a Congruency Review?
•What errors occur in congruency reviews besides human error?
