Data Integrity Health Check
Find out if your life science company is compliant with FDA Data Integrity Guidance. With the release of the guidance in April of 2016, many companies are struggling to re-assess their compliance with data integrity controls and principles. There has been a significant increase in the number of regulatory enforcement actions because of data integrity issues.
The discussion will include:
- USDM’s unique data integrity wellness health check
- Practical guidance on organizational controls, technical controls and operational factors critical to data integrity/data reliability
- Live Q & A session
About the Presenter:
Bob Lucchesi is the Vice President of Global Regulatory Compliance, Quality Assurance and Auditing at USDM Life Sciences.His expertise extends to several USDM Life Sciences practice areas, including Enterprise Quality Management, Enterprise Content Management, Quality Management Systems, and Governance, Risk and Compliance.Bob offers almost 30 years of experience in quality assurance and regulatory compliance in pharmaceuticals, bio-tech, medical device, engineering and nuclear industries.Among his many accomplishments, Bob gives presentations on a variety of compliance and regulatory subjects worldwide, including most the new ASTM: E2500 model for validation and a variety of life science auditing topics.Bob has led audit teams for Quality, mock FDA, policies and procedures, Part 11, NIST, supplier-vendor (internal, external, sterile, non-sterile, manufacturing, logistics), mock recalls, and major life sciences assessments. Bob is also an expert in risk based validation methodologies, GAMP, enterprise content management, data and content migrations as well as overall pharmaceutical and medical device regulatory issues. For the past year, Bob has conducted specific data integrity audits following the new guidelines set forth by the FDA.