Technological Advances
Decentralized Clinical trials have become increasingly prevalent in the biotech and biopharmaceutical industries.
Decentralized Clinical trials have become increasingly prevalent in the biotech and biopharmaceutical industries. Experts suggest the value of DCTs will increase by 9.8% between 2023 to 2029. Decentralized Clinical trials are cost effective and offer many benefits to researchers and participants alike, which is likely the cause of their increased usage. However, there are also some risks involved. To address this, the FDA released draft guidance to regulate DCTs and ensure participant privacy and data is protected. The guidance covers data collection and storage, investigator and sponsor responsibilities, and more.
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FDAQRC and Compliance Architects Join Forces
For years, FDAQRC and Compliance Architects have brought complementary expertise across the product lifecycle. Now, we’ve joined forces to provide clients with broader compliance expertise and resources—from clinical and laboratory compliance to GMP, quality systems, and commercial operations.
Turning FDA 483s and Warning Letters into Opportunities for Improvement
Learn how to turn an FDA Form 483 observation or Warning Letter into a strategic opportunity for improvement with robust CAPA and root cause analysis.
Preventing Future Compliance Issues Through Proactive Measures
Many have heard the idiom “an ounce of prevention is worth a pound of cure.” More simply stated, the Oxford Languages Dictionary states that “it is easier to stop something from happening in the first place than to repair the damage after it has happened.”
Decoding Your FDA Form 483 and Warning Letter: A Practical Guide to Remediation
This article explains how to interpret an FDA Form 483 and Warning Letter, identify underlying causes, and develop an effective remediation strategy. It emphasizes the importance of timely, well-documented corrective action and provides practical guidance for addressing inspectional observations.
How to Prepare for an FDA Inspection: A Step-by-Step Guide
An FDA inspection doesn't have to be daunting. Our step-by-step guide provides a roadmap for proactive preparation, covering everything from QMS review to effective FDA-483 responses. By taking a proactive approach, you can ensure your team is ready for a successful inspection outcome.
Practical Guide on How to Adapt Your Auditing Practices for the Implementation of ICH E6 (R3)
Download this poster to explore how evolving global guidance is shaping the future of auditing, including risk-based approaches, updated SOPs, and technology-driven practices.
Understanding Quality Oversight: Monitors vs. Auditors vs. FDA: A Quality Perspective
A practical breakdown of how monitors, auditors, and FDA inspectors each contribute to quality oversight, compliance, and inspection readiness across the trial lifecycle.
A Closer Look at Inspection Readiness: Mock/Hats On-Off Approach
A practical framework for strengthening compliance, inspection behaviors, and organizational preparedness for regulatory inspections