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 Should Attend:
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
Course Director: PAUL LABAS
Paul Labas serves as Director of IT Compliance and CSV practice at IPS – Integrated Project Services, a life sciences industry consulting firm headquartered in Blue Bell, PA. Mr. Labas offers over 15 years of experience and expertise in all aspects of Computerized and Automated Systems Compliance, Computerized Systems Validation and Electronic Data Integrity.
Paul’s diverse experience includes high-risk projects such as establishment of organizational compliance frameworks, responses to consent decrees, and validation of systems in use by more than 100,000 people worldwide. Mr. Labas is involved on numerous ISPE initiatives, including formal peer reviews and authorship of industry guidance documents.