Moorpark, CA – Jamie Colgin, President of Colgin Consulting, Inc. and Principal Consultant for Validant, announced today that she has been invited to speak at the Food and Drug Law Institute’s (FDLI) Enforcement, Litigation, and Compliance Conference for the Food, Drug, and Tobacco Industries 6-7 December 2017 in Washington, DC.
Jamie Colgin will be participating in the panel discussion on Quality Systems Approach to Data Integrity, and will speak specifically to the Enforcement Problem: 21 CFR Part 312 vs. the Reality of Clinical Trials.
“Data integrity can be a problem in clinical trials. However, GCP enforcement actions in the US have lagged behind GMP enforcement. Part of that is due to the disconnect between regulatory requirements and the way clinical trials are conducted today,” says Jamie Colgin. “I’m looking forward to hearing the perspectives of regulators, industry representatives, and attorneys.”
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. 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.