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Live Webinar Data Integrity Key-Considerations
June 21, 2021 @ 8:00 am - 5:00 pm
Data Integrity: What Regulators Are Looking For
Data integrity is a key component in making informed decisions within any regulated organization. Reliable data promotes good decisions. Unmanaged and inaccurate data will have consequences on a company’s quality output, state of compliance, the risk to patient safety, and ultimately, the bottom line.
There are many risks inherent in poor data management. Without the ability to eradicate these risks, gaps will inevitably exist and a quality system will not reach a reliability level that government agencies such as the FDA, expect to see.
FDA expects that all data be reliable and accurate. Firms should implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models. This webinar focuses on principles of DI and how to manage DI issues and prevent recurrence.
Ensure your data integrity program is compliant. Develop a strategy after getting the information you need in this live webinar.
- What is Data Integrity and why is it important?
- Regulatory Background
- Types of Data Integrity
- Key principles of Data Integrity and ALCOA+
- Elements of Data Integrity
- Leading causes of Data Integrity failures
- Evaluating Data Integrity Compliance
- How to comply with FDA Data Integrity requirements?
- Data Integrity by Design
- Data Integrity and automated systems
- Data Integrity most common root causes and how they can be addressed?
- FDA warning letters and 483s related to Data Integrity
- Data Integrity and cGMP
- Current Data Integrity trends in Pharmaceutical Industry
- Case Studies
Note: Course outline is subject to change without notice. Please check back regularly for updates.
Who Should Attend
This webinar is intended for anyone involved with Quality Assurance in Pharmaceuticals, Food, or Cannabis.