A Clinical Hold is one of the most expensive surprises in drug development — costing sponsors six to twelve months of delays and up to $2 million in team and site expenses. What makes it worse is that most of these holds are preventable. Across more than 150 IND submissions, the same Chemistry, Manufacturing, and Controls mistakes surface time and again, and FDA reviewers are growing less forgiving of them. This webinar exists to show you every one of those mistakes before they show up in your own review letter.

In this training, the trainer will walk you through of the 7 CMC deficiencies most commonly cited in Clinical Hold letters — from insufficient drug substance characterization and poorly timed analytical validation, to stability data gaps, incomplete impurity profiles, and release specifications that lack proper justification. Each mistake is examined through a real-world example, with a clear explanation of why FDA flags it and exactly what you need to do to fix it. You’ll also work through FDAMap’s CMC Self-Assessment Tool in real time, so you leave the session knowing your own top risk areas.

The final segment shifts from diagnosis to strategy. You’ll learn what FDA genuinely expects at Phase 1 versus what can safely wait for later phases, how to write a CMC narrative that speaks directly to reviewer concerns, and how a well-prepared Pre-IND meeting briefing document can prevent most holds before they ever occur. Whether you’re 6 months from filing or just starting to build your CMC package, this session gives you a practical, pre-submission roadmap.

Topics to be Covered:

• Identify the 7 most common CMC deficiencies cited in FDA Clinical Hold letters
• Understand what FDA reviewers specifically look for in IND Module 3 (drug substance and drug product sections)
• Build a pre-submission CMC checklist that mirrors FDA’s internal review criteria
• Know when your CMC package is “good enough for IND” vs. when it needs more development work
• Develop a Phase 1 → Phase 2 CMC evolution plan that avoids information amendments

Why Should You Attend?

While clinical strategy often gets the spotlight, CMC deficiencies remain a leading cause of FDA clinical holds. By attending, you gain exclusive access to a retrospective analysis from an expert who supervised over 100 clinical trials, revealing the exact patterns that lead to submission failure. We move beyond generic guidance to provide a phase-appropriate roadmap, teaching you how to balance scientific rigor with the speed required for Phase 1. Don’t let a technical oversight derail your breakthrough. Secure your “Safe to Proceed” letter by mastering the complexities of Module 3 through a comprehensive root cause evaluation before you hit “submit.” 

Avoid costly delays and regulatory setbacks by learning exactly what triggers FDA Clinical Holds in IND submissions This webinar gives you a clear understanding of the 7 most common CMC mistakes and how to prevent them before they impact your timeline and budget. Whether you’re preparing to file or refining your approach, this session equips you with actionable insights to reduce risk and accelerate development with confidence.

Who Will Benefit:

• VPs and Directors of Regulatory Affairs

• Regulatory Affairs Managers

• Quality Assurance Professionals

• Medical Directors

• Clinical Program Managers

• Clinical Trials Professionals

• Clinical Development Manager

• CRO Professionals

• Drug Development Scientist

• Biomedical Research Scientist

• Biotech and pharma CEOs managing investor expectations on timeline