Pharmacovigilance Signal Detection & Management – Training session
The Essentials of Pharmacovigilance Signal Detection – Pharmacovigilance Signal Detection & Management Training session Effective Pharmacovigilance Signal Detection is critical for patient safety and remains the primary method for identifying previously unknown adverse reactions. During our recent face-to-face session in Bengaluru, we explored how modern data science is transforming this field. The Signal Management […]
Medical Device CGMP: Quality System Regulations Guide
Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) […]