This 90-minute webinar provides an overview of the GXP requirements for review of original records, including source electronic records and meaningful “metadata”. The discussion will include defining “metadata” and “critical” data, including data that is essential to assuring patient safety, product quality, and the reliability of regulatory submissions. We will discuss the application of holistic Quality Risk Management principles to conduct risk-based reviews that add value and strengthen the confidence of our decision-making. The case study presented will provide participants the opportunity to review both paper and electronic data sets, as well as metadata, such as audit trails. This hypothetical scenario raises important questions regarding our historical data review approaches and calls us to modernize our data review strategies to design the most efficient and effective techniques to assure patient safety and product quality. In addition, for those interested, this webinar offers an additional 30 minutes for Q&A upon completion of the webinar, from 12:30pm-1:00pm ET.
Example topics include:
• Data Review—General Concepts
• What is “Data” and “Metadata”?
• Audit Trails & Review? Which Ones? How Often?
• Where should review take place in context of the Data Life Cycle?
• Critical Thinking Skills to Identify Patterns
• US FDA & EU Observations
• Case Study