Fundamentals Of Type III DMFs Course

Properly submitted and well maintained packaging supplier DMFs are key to any smooth NDA process. FDA deficiency letters that result from poorly organized and/or incomplete DMFs can be costly and put your company’s reputation at risk.
This short, intense session will provide both Type III DMF holders and their clients with valuable insights how to do it right from the start, how to avoid deficiencies, and deal with the most frequent issues. Practical, real life examples will be shown and discussed throughout the program.

Explore the benefits of a proactive approach to save your organization money and headaches:

> Learn how to write, organize, and submit a Type III DMF

> Understand the structure and composition of a robust Type III DMF

> Identify proper content - key pitfalls to avoid

> Organization tips to provide for easier DMF maintenance

> Annual updates and other amendments

> Letters of Authorization (LOAs)

> Dealing with deficiency letters – appropriately address FDA’s concern

> Assess supplier Type III DMF’s

> Understand the role Type III DMFs play in the FDA’s guidance on Post Approval Changes (interchangeability)

Instructor: Frank Bieganousky