| Workshop Details
Time - 2:00 pm - 4:00 pm
Cost - CAD $350 + HST
Location - Online. Live. Interactive. Instructor Led
Abstract: 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.
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.
Course Outline - 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
Who Should Attend This webinar is intended for anyone involved with Quality Assurance in Pharmaceuticals, Food, or Cannabis.
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