Data Integrity and trustworthiness, the fundamental goals of computer system validation (CSV) and compliance, have recently become a focus of the US Food and Drug Administration (FDA) and other global regulatory agencies’ enforcement actions. In 2013, FDA cited data integrity issues in 27% of its warning letters. In 2014 that number jumped to 73%, with vast majority of noted deficiencies citing issues with electronic records and computerized systems. The trend continued in 2015, when data integrity was cited in every single warning letter issued to API manufacturers.
Despite the current regulatory landscape being as complex as ever, new FDA enforcement actions have added another degree of confusion as you try to keep your firm compliant. Regulated companies are faced with the seemingly impossible task of operating in a manner that is fully compliant and cost-effective, while mitigating risks to patient safety, product quality and data integrity. Thankfully, there are definite ways to achieve these goals.
This course will focus on the current top five FDA regulatory enforcement trends relevant to computerized systems compliance, validation, and data integrity.
This 90-minute session will cover essential topics such as:
- History of computerized systems regulations
- Current regulatory landscape, including laws, regulations, and guidance documents
- Agencies’ expectations relevant to Data Integrity
- Top FDA enforcement trends based on analysis of recent Consent Decrees, Warning Letters and FDA Form-483
- Best industry practices for addressing the top five regulatory pitfalls
- Maximizing compliance and minimizing costs through a science-driven, risk-based approach to CSV