North Florida Chapter: Inspection Readiness: It's All About the Data (ACRP 2025 Conference Replay)
This event will be presenting a replay sessions from the ACRP Conference Library
Event Description:
Leveraging electronic tools is essential for maintaining inspection readiness in today’s regulatory landscape. Paper-based methods are cumbersome and time-consuming, and they create logistical challenges in record keeping. In contrast, technology offers centralized record keeping, and electronic file storage is now both cost-effective and user-friendly. This shift is underscored by updated guidelines such as ICH E6(R3), which promotes media neutrality, flexibility, innovation, proactive quality, and robust data governance. Additionally, remote regulatory assessments, which were proven effective during the pandemic, enhance efficiency, flexibility, and global reach while reducing travel and disruption. Despite these advancements, recent feedback from regulators indicates a regression in the adoption of these technological tools. It is time for sponsors to embrace risk proportionality, which is supported by regulatory authorities, to maintain inspection readiness.
Speaker:
Marc Wartenberger, CQA, CTFL, Senior Director, Security, Corporate QA & Compliance, CRIO
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Registration & ACRP Contact Hour Information:
- Chapter Member (registration with or without contact hour): $0
- ACRP Member (registration only): $5
- ACRP Member (registration + contact hour): $20
- Non-Member (registration only): $5
- Non-Member (registration + contact hour): $80
After registering, please visit the event's community page to find the login information or any additional event updates, and to communicate with the event organizer.
To claim contact hours: Register and purchase the contact hours and attend the event. After attending the event, visit learning.acrpnet.org and log into your ACRP account. Click the “GO TO MY COURSES” box. Find the event in your dashboard, confirm your attendance, and take the event evaluation between 1 and 30 days following the event to obtain the online certificate. After 30 days, contact hours are no longer available.