Understanding 21 CFR Part 11: Electronic Records & Signatures
Learn about 21 CFR Part 11, the FDA regulation for electronic records and signatures. This article covers its history, purpose, and significance in the pharmaceutical industry.
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Articles tagged with “fda-regulations”
Good Manufacturing Practice (GMP): Pharma Quality Assurance Guide
Explore Good Manufacturing Practice (GMP) in pharma. Learn its principles, global regulations, implementation, and compliance challenges for quality assurance.
Computer System Validation in Pharma & Biotech Compliance
Learn what Computer System Validation (CSV) is, its crucial role in pharmaceutical and biotech compliance, ensuring data integrity and regulatory adherence for patient safety.
Pharmaceutical Marketing Regulations: A Comprehensive Overview
In-depth guide to U.S. pharmaceutical marketing regulations: FDA, FTC, Sunshine Act, anti-kickback, compliance, and IT obligations for pharma companies.
AI and the Future of Regulatory Affairs in the U.S. Pharmaceutical Industry
An analysis of how artificial intelligence is transforming regulatory affairs in pharmaceuticals, from submission preparation to compliance monitoring and regulatory intelligence.
Compliance Frameworks in Pharmaceutical IT: A Comparative Analysis
A detailed comparison of key compliance frameworks in pharmaceutical IT, including FDA 21 CFR Part 11, GDPR, HIPAA, and GxP, with implementation strategies and best practices.
Non-Personal Promotion (NPP) to HCPs: A Comprehensive Guide for Pharma Marketers
A detailed exploration of Non-Personal Promotion strategies in pharmaceutical marketing, covering best practices, compliance requirements, and tools for effective HCP engagement without face-to-face interaction.