Resources for RA/QA/Clinical Teams: The FDA Group's Entire Premium Content Repository

Access every white paper and webinar we've ever produced — a library of life science insights you won't find elsewhere.

Below are quick links to white papers and recorded webinars that tens of thousands of regulatory, quality, and clinical professionals working in the FDA-regulated industries have downloaded over the years. We’ll add new resources to this page as they’re published.

Beyond the index, the links to the resources are only available to paid subscribers, who can access these anytime.

Index

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White papers:

• 📄 Revisiting the Value of Interim Consultants and Contractors in Today’s Life Science Talent Market

• 📄 A Modern Guide to Clinical Operations Resourcing

• 📄 A Solution for On-site Supplier Pre-Assessments Both During and After the Pandemic

• 📄 GMP Auditing and COVID-19: A Guide to Remote Auditing and Workforce Recovery

• 📄 The Life Science Quality Leadership Report & Benchmark: 2020

• 📄 Gap Analysis Remediation: A Guide to Resourcing & Implementation

• 📄 The OTC Drug Manufacturer's Guide to CGMP Compliance & Quality Management

• 📄 Preparing for a Life Science Validation Project

• 📄 Clearing Complaint Backlogs: A Guide to Efficient Complaint Management

• 📄 The Guide to CAPA & Root Cause Analysis in FDA-Regulated Industries

• 📄 The Complete Guide to EU-MDR Transition

• 📄 The Importance of CGMP to the Safety of Compounded Drugs

• 📄 Preparing for the Medical Device Single Audit Program (MDSAP)

• 📄 Harmonizing Disparate Quality Systems

• 📄 Ensuring Enterprise-Wide Data Integrity in FDA-Regulated Industries

• 📄 The Complete Guide to Supplier Qualification & Quality Management

• 📄 The Emergency Guide to FDA Warning Letters & FDA 483

• 📄 The Complete Guide to Compliance Remediation Projects

Webinars:

• ▶️ Identifying and Preventing the Most Common Drug and Device cGMP Issues

• ▶️ Practical Advice for Planning and Hosting Remote Life Science Quality Audits

• ▶️ Life Science Quality Outlook 2020: Goals, Challenges & Expert Perspectives

• ▶️ Resourcing & Implementing Gap Analysis Remediation

• ▶️ CGMP & Quality Management for OTC Manufacturers: 6 Critical Questions

• ▶️ Ask an FDA Expert Anything

• ▶️ The Complete Guide to Root Cause Analysis & CAPA

• ▶️ The Complete Guide to EU-MDR Transition

• ▶️ The Importance of CGMP to the Safety of Compounded Drugs

• ▶️ Harmonizing Disparate Quality Systems

• ▶️ Preparing for the Medical Device Single Audit Program (MDSAP)

• ▶️ Ensuring Enterprise-Wide Data Integrity in FDA-Regulated Industries

• ▶️ Qualifying Suppliers & Managing Quality in FDA-Regulated Industries

• ▶️ Recovery From Warning Letters & FDA 483

• ▶️ How to Remedy the Root Cause of Compliance Problems