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Getting Ready for SOS 2025: FDA 483s, SOPs, and Site Survival
In this conversation, Edye Edens and Darshan Kulkarni discuss the excitement and plans for the upcoming Save Our Sites (SOS) Second Annual Conference in Oklahoma City. They highlight the importance of connecting with key industry leaders and peers in person, including names like Dan Sfera, Brad Hightower, and others who have been instrumental voices in the clinical research space.
Darshan shares that Kulkarni Law Firm (KLF) will be participating and is excited to engage with attendees, talk about their offerings, and provide exclusive giveaways related to compliance and FDA inspections. Darshan emphasizes that KLF will focus on how to prevent and respond to FDA 483s, covering topics like audit readiness, proper handling of inspections, and how to de-escalate findings before they escalate into warning letters. He also underscores the importance of understanding the inspection process, including the fact that "it's a negotiation until the report is issued," and the role of policies, procedures, and professional conduct during audits.
Edye highlights her session on SOPs (Standard Operating Procedures), where she will speak alongside Jen Pages, Scott Wit, and Brad Hightower (moderator). Their panel will cover critical topics like:
- How to start SOPs if you don’t have any
- Scaling SOPs as your site grows
- Using SOPs strategically to protect and defend sites in audits and inspections
- Addressing sponsor expectations regarding site processes
They aim to address real-life issues sites face, including how to tailor or adapt SOP templates and how to leverage them to prevent issues with sponsors and regulators. A surprise giveaway will also be available for those who attend the session.
Both Edye and Darshan emphasize that SOS is about community supporting community, not just traditional presentations. The goal is to share actionable, free value, foster real conversations about clinical site challenges, and help each other grow in the clinical research space. They also playfully joke about friendly competition on session attendance, adding a light-hearted tone to the conversation.
In summary, attendees can expect:
- Deep dives on 483 prevention and response
- Practical SOP guidance for sites
- Meaningful networking and community building
- Unique giveaways and actionable takeaways
Stay tuned for more updates.
Support the show
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By Darshan Kulkarni
4.3
66 ratings
In this conversation, Edye Edens and Darshan Kulkarni discuss the excitement and plans for the upcoming Save Our Sites (SOS) Second Annual Conference in Oklahoma City. They highlight the importance of connecting with key industry leaders and peers in person, including names like Dan Sfera, Brad Hightower, and others who have been instrumental voices in the clinical research space.
Darshan shares that Kulkarni Law Firm (KLF) will be participating and is excited to engage with attendees, talk about their offerings, and provide exclusive giveaways related to compliance and FDA inspections. Darshan emphasizes that KLF will focus on how to prevent and respond to FDA 483s, covering topics like audit readiness, proper handling of inspections, and how to de-escalate findings before they escalate into warning letters. He also underscores the importance of understanding the inspection process, including the fact that "it's a negotiation until the report is issued," and the role of policies, procedures, and professional conduct during audits.
Edye highlights her session on SOPs (Standard Operating Procedures), where she will speak alongside Jen Pages, Scott Wit, and Brad Hightower (moderator). Their panel will cover critical topics like:
- How to start SOPs if you don’t have any
- Scaling SOPs as your site grows
- Using SOPs strategically to protect and defend sites in audits and inspections
- Addressing sponsor expectations regarding site processes
They aim to address real-life issues sites face, including how to tailor or adapt SOP templates and how to leverage them to prevent issues with sponsors and regulators. A surprise giveaway will also be available for those who attend the session.
Both Edye and Darshan emphasize that SOS is about community supporting community, not just traditional presentations. The goal is to share actionable, free value, foster real conversations about clinical site challenges, and help each other grow in the clinical research space. They also playfully joke about friendly competition on session attendance, adding a light-hearted tone to the conversation.
In summary, attendees can expect:
- Deep dives on 483 prevention and response
- Practical SOP guidance for sites
- Meaningful networking and community building
- Unique giveaways and actionable takeaways
Stay tuned for more updates.
Support the show