In April 2016, the FDA issued its draft “Data Integrity and Compliance with cGMP Guidance for Industry.” This document quickly followed similar documents issued by other global regulatory bodies including the Medicines and Healthcare products Regulatory Agency (MHRA) and World Health Organization (WHO). These documents were issued in response to the increase in data integrity observations during inspections. FDA, for one, is taking this issue seriously as it stated in the draft guidance that the rise in data integrity observations “is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health.”
The regulatory expectation that data must be reliable and accurate is certainly not new (as mentioned in the predicate rules), but these documents serve to clarify and standardize current thinking. The focus of this training is to review, compare, and contrast currently available draft and final guidance documents in order to understand the various agencies’ current thinking on data integrity and how it impacts the GxP-regulated industry. The outcome will be the delivery of data governance strategies that position organizations for compliance.
Attend this interactive 90-minute webinar and you will…
This course will be useful to anyone working in a GxP environment including those in clinical, manufacturing, regulatory, laboratory, document management, and general data-intensive settings. Those responsible for data security, gathering, maintenance, and/or use will find this session particularly beneficial.
Alecia Adams, RQAP-GLP, PMP, ASQ CSQE, is an independent consultant located in Denver, CO, specializing in FDA GLP quality system compliance and GxP computer systems validation. Ms. Adams has 18 years of combined experience in technical operations, quality assurance, and information technology. The last eight years specifically have been spent auditing, developing, implementing, and maintaining quality systems, with a special emphasis on computer systems validation and data integrity in GxP environments. She has worked in this capacity with organizations that include university laboratories (GLP, GCLP), biologics manufacturers (GMP), CROs (GLP, GCP), and global medical devices companies (QSR). She is an active member of the American Society for Quality (ASQ) as well as the Society of Quality Assurance (SQA).