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.
6-Hour Virtual Boot Camp on Microsoft Power BI
2-Hour Virtual Seminar on Empowering Presentations with Pow…
Motivated to Stay: Effective and Best Practice Retention Me…
2-Hour Virtual Seminar on The Complexity and Interplay Amon…
The Anti-Kickback Statute: Enforcement and Recent Updates
Mindful Communication:The Key to Meaningful Conversations i…
Managing Toxic & Other Employees Who Have Attitude Issues
How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…
Employee Handbooks: 2025 Critical Issues
Accounting For Non Accountants : Debit, Credits And Financi…
ChatGPT and Project Management: Leveraging AI for Project M…
50+ new Excel features so far this decade
2025 EEOC & Employers: Investigating Claims of Harassment …
Why EBITDA Doesn't Spell Cash Flow and What Does?
Retaining Talent in the Age of Employee Shortages
Succession Planning Simplified: Fast-track Your Future Lead…
Workplace Compliance in 2025: New Laws, Big Changes, and Wh…
How to Write Contracts for Procurement Professionals
Leverage AI & ChatGPT for Talent Acquisition: Best Practice…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Female to Female Hostility @Workplace: All you Need to Know
Leadership: Strategic Planning and Decision Making