With the recent increase in FDA Warning Letters issued to universities, it is crucial for those involved in clinical trials to fully grasp the regulations that guide them. In this webinar, we present a case study that explores the serious consequences of non-compliance, demonstrating what can occur when universities and pharmaceutical companies fail to understand and adhere to these laws.

Clinical trial regulations are not merely guidelines but laws that must be followed. This includes compliance with requirements for appropriate instrumentation, equipment, qualified personnel, standardization, and documented procedures to ensure the safety of trial participants and the integrity of the data collected.

The case study highlights a routine FDA investigation of a laboratory, which led to the imprisonment of the individual overseeing the bioanalytical sample evaluations. Due to improper conduct and flawed reporting, the FDA invalidated this phase of the clinical trial, irreparably damaging the reputations of the
university, the Principal Investigator, and the Sponsor. Moreover, the Sponsor suffered a significant loss in stock valuation as a result of the FDA’s findings.

This webinar underscores how insufficient process controls can compromise the integrity of your study and the critical importance of understanding the specific regulations that apply to your trial. By integrating sound scientific and regulatory practices, your organization can avoid the costly pitfalls that impacted this clinical trial.

Learning Objectives:

• Learn how regulatory compliance safeguards the integrity of your data and helps you avoid legal and prosecutorial risks.
• Gain insight into how regulatory requirements can directly impact the drug approval process.
• Develop a deeper understanding of ALCOA+ (Data Integrity) principles and their critical importance in clinical research.

Jera Kantz, MBA, LATG, RQAP-GLP

With over 16 years in the CRO industry, Jera A. Kantz, MBA, LATg, RQAP-GLP, serves as the Quality Assurance Manager at Alturas Analytics, Inc. Jera’s early history as a Research Associate II (RAII) with a focus on experimental therapeutics provided the background and a passion for the preclinical drug research process. After obtaining her AALAS LATG certification she then transitioned to Quality Assurance Auditor at MPI Research.

In 2013, Jera joined the Charles River Laboratories QAU and quickly advanced to Senior Quality Systems Auditor. She hosted numerous client audits and became proficient at auditing computer systems validations and bioanalysis across immunogenicity, cell culture, flow cytometry and PCR techniques. An important aspect of Jera’s position is training auditors and general site staff in GLP, GCP, and Part 11 compliance, OECD principles and other applicable Guidance for Industry. Influencing others to embrace compliance that intuitively leads to generation of quality data and patient safety is her ultimate goal.

Jera is an active member and contributor to the Society of Quality Assurance. Since early 2024, Jera has served as the Vice President of the Pacific Regional Chapter of Society of Quality Assurance (PRCSQA).