Data Integrity – Regulatory Expectations and Best Practices to Reduce Risks

Data integrity is one of the most important aspects of the Life Science industries. Critical business decisions, intellectual property, and regulatory compliance all depend on reliable, accurate data that is properly maintained and safe guarded from uncontrolled alterations.

Ensuring data integrity compliance requires a cultural acceptance from top to bottom within your company, including both Quality and Research organizations. Embracing data integrity earlier in the product life cycle helps ensure reduced compliance risk and remediation costs, as well as higher product quality, better decision making, and faster time to market. This presentation includes three main components; explaining regulatory expectations for data integrity compliance, examples of data integrity non-compliance and their impact on your business, and practical examples of activities that can reduce data integrity risk in your laboratory. This webinar should be attended by Laboratory Management, Scientists, Compliance Specialists, and Lab IT personnel.

Presenter: Michael Korbel (Sr. Compliance Consultant, Agilent Technologies, Inc.)

Michael has over 22 years of experience in regulated environments in the pharmaceutical and bio-tech industries. Half of Michael's career has been spent on the customer side of the industry in both IT and laboratory positions, supporting, qualifying, and validating regulated instruments and computerized systems. The other half has been spent providing consultative compliance service programs from the vendor side of the industry. His experience includes technical support and validation of both standalone and enterprise laboratory informatics systems, as well as instrument qualification, preventive maintenance, and relocation services. Michael’s current role at Agilent Technologies is to create new compliance consulting services for our regulated customers and implement them globally. Michael holds a B.S. in Biology, with minors in Chemistry and Environmental Science.