Overview:

This webinar will showcase how SaaS and AI-powered tools are transforming FDA inspection readiness and ANDA submission success - empowering teams to align with the 6-system cGMP model, eliminate deficiencies, and streamline regulatory documentation for faster, smarter compliance.

Areas Covered in the Session:

• Understand the FDA's structure, focusing on CDER and its key offices involved in drug approval.
• Gain insights into the standard ANDA review timeline and strategies to avoid submission delays.
• Identify common triggers of FDA 483 observations and warning letters and how to prevent them.
• Explore how the FDA uses RBR, RBS, and RBI models to assess and prioritize inspection risks.
• Understand the FDA inspection approach, including Pre‑ANDA and full cGMP inspections and their classifications.
• Review the 21st-century FDA cGMP audit model based on six critical systems.
• Learn how AI-powered regulatory tools support high-quality application filings and minimize deficiencies.
• Experience a live demo of our SaaS platform for analysing 483 observations and warning letters using smart filters and search.

Why should you attend?

• To Gain Strategic Advantage: Learn how AI-driven tools like the ANDA deficiency roadmap and 483 databases can help you proactively close regulatory gaps and avoid costly submission delays.
• Understand FDA Expectations: Get a clear view of FDA’s structure, inspection process, risk scoring systems (RBR, RBS, RBI), and how inspection outcomes (NAI, VAI, OAI) impact your compliance.
• Accelerate Your Filings: See a live demo of our SaaS platform that empowers you to search and export targeted observations, anticipate inspection triggers, and benchmark against real-world FDA trends.
• To Strengthen Compliance Systems: Explore how iTechnicalTools can help you to reduce repeated 483 observations.
• To Stay Compliant & Competitive: Walk away with actionable insights, real-world benchmarking tools, and best practices that align with FDA trends—keeping your organization ahead of regulatory risks.

Who should attend?

• Regulatory Affairs Professionals
• Quality Assurance & Compliance Teams
• Manufacturing & Operations Managers
• Research & Development (R&D) and CMC Teams
• Pharma Executives & Decision Makers