Moorpark, CA – 10 March 2018 – Jamie Colgin, President of Colgin Consulting, Inc. and Principal Consultant, Validant, will be a featured expert panelist for the Food and Drug Law Institute’s (FDLI) live webinar entitled “Data Integrity: FDA Enforcement and Risk-Reduction Considerations.” The webinar takes place on Tuesday 13 March 2018 from 2:00 to 3:30 EST. The webinar will be available for listening within four days of delivery.
According to FDLI, more than 60% of FDA warning letters cited data integrity issues in 2017. While most of industry’s attention is currently on data integrity in manufacturing, data integrity issues in clinical trials can result in data loss and submission delays. When this happens, we have failed to honor the clinical trial subjects’ gift of participation. Jamie’s contribution will include data integrity and enforcement challenges resulting from the way clinical trials are conducted today and a case study demonstrating those challenges.
The panel also includes two of FDA’s leading authorities on data integrity, Sara Barkow and Paula Katz, and industry expert Michael A. Swit, Partner, Law Office of Michael A. Swit. Jack Garvey, Founder and CEO of Compliance Architects LLC, will serve as moderator.
Register for the live webinar at https://www.fdli.org/2018/03/data-integrity-webinar/.
About Jamie Colgin
Jamie Colgin is an award-winning, formally trained educator who shares vital information on data integrity in clinical trials and the latest compliance and quality assurance happenings in the pharmaceutical industry. She is a member of the Society of Quality Assurance’s 2017 Distinguished Speaker Inventory, a Certified Quality Auditor through ASQ, and a Certified Information System Auditor and Certified in Risk and Information System Control through ISACA. Visit www.colginconsulting.com for more information.
Validant is the leading Quality, Compliance, and Regulatory consulting firm, blending industry expertise with innovation to create custom solutions for companies on the frontier of health. Visit www.validant.com for more information.
FDLI “is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in the field of food and drug law. As a neutral convener, FDLI provides a venue for stakeholders to inform innovative public policy, law, and regulation.” For more information, visit www.fdli.org.