Data Integrity and trustworthiness, the fundamental goals of computerized systems compliance and validation (CSV), have recently become a specific focus of severe and numerous enforcement actions by the US Food and Drug Administration (FDA) and other global regulatory agencies. In 2013, FDA cited data integrity issues in 26% of its warning letters. Recently, that number jumped to 85%.
Despite the current regulatory landscape being as complex as ever, with new FDA enforcement policies added to an array of applicable laws and regulations, the regulated companies are expected to operate in a manner that is fully compliant and cost-effective, while mitigating risks to patient safety, product quality and data integrity.
This course will focus on the current top five FDA regulatory enforcement trends relevant to computerized systems compliance, validation, and data integrity. It will particularly be useful to those who interface with vendors, FDA and other regulatory agencies.
Areas Covered in the Session :
- Brief history of computerized systems regulations
- Current regulatory landscape, including laws, regulations, and industry 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
- Top five regulatory pitfalls and best industry practices for addressing them
- Maximizing compliance and minimizing costs through a science-driven, risk-based approach to CSV
Who Will Benefit:
This course will be of benefit to anyone involved in any aspects of computerized systems compliance, computerized systems validation, and regulated GxP data management. A must attend webinar for the following departments:
- Quality Assurance
- Regulatory Affairs
- Research & Development
- Quality Control