The outcome of regulatory inspections is critical to an organization’s success. The FDA performs inspections to check that companies are maintaining compliance with applicable regulations and quality standards. Though you do your best to avoid it, receiving a 483 or Warning Letter is inevitable. It’s important to take the observations very seriously because you only have 15 days to submit the subsequent responses.
But ensuring that you are aware and understand what the regulatory agency is expecting in the response can be a challenge. What should you include? What are the risks of not submitting an appropriate response?
This 90-minute course will discuss the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response. Additionally, this course will review the proper structure of the response to ensure the regulatory agency’s expectations are met and the submission process.
At the completion of this session, you will be able to:
This course will be valuable to anyone engaged in the development, manufacturing, sale, or distribution of FDA-regulated healthcare products. Additionally, this course will provide a good primer for those involved in writing observation responses. This includes personnel in:
At the completion of this session, you will be able to:
This course will be valuable to anyone engaged in the development, manufacturing, sale, or distribution of FDA-regulated healthcare products. Additionally, this course will provide a good primer for those involved in writing observation responses. This includes personnel in:
Kelly Thomas
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Hiring and Retaining Employees in this Crazy Economy
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Excel Power Skills: Master Functions, Formulas, and Macros …
Project Management for administrative professionals
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Copilot and HR: An Introduction for HR Professionals
California Meal and Rest Breaks: What You Don't Know Can Co…
Bootcamp for New Managers and Supervisors: Develop These Es…
Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…
Emotional Intelligence: Mastering the Emotions of Great Lea…
How To Conduct An Internal Harassment And Bullying Investig…
Managing Difficult Employee Conversations
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
The Importance of the first 5 seconds when presenting
Female to Female Hostility @Workplace: All you Need to Know
How to Write Effective Audit Observations: The Principles f…
FDA Proposes Framework to Advance Credibility of AI Models