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.
Understanding the Artificial Intelligence Landscape
Holiday Stress and Loss: The Art of Stress Resilience in E…
Establishing Appropriate Quality Metrics and Key Performanc…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Is Your Culture Working For or Against Your Success? If You…
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Using High-Performance Coaching for Managers to Address Per…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Red flags that can render your OSHA Safety Program Complete…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
The Human Element of Leadership in the Hybrid Work Experien…
Transform Data into Insights: A Beginners Guide to Excel Pi…
What If Analysis Tools in Excel: Goal Seek, Solver, and Dat…
How to Navigate Political Speech in the Workplace
Project Management for administrative professionals
How to Prepare For and Host a FDA Inspection and Respond to…
Mastering Year-End Payroll and Tax Compliance for 2024
3-Hour Virtual Seminar on Chat GPT for Project Management i…
Eliminate Harmful And Unproductive Drama In The Workplace
FDA Technology Modernization Action Plan (TMAP) and Impact …
The Anti-Kickback Statute: Enforcement and Recent Updates
5 Key Components of Good Manufacturing Practices to obtain …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Team Synergy: How to Harness Collective Intelligence to Max…
Managing Toxic & Other Employees Who Have Attitude Issues
Successful Strategies for FDA Expedited Pathways for Your D…
Protect Your Company With The End of the Year HR Checklist
The Power Of Trust In The Workplace- Improving Your Career …
Do's and Don'ts of Giving Effective Feedback for Performanc…
So, You’re Now the “Boss”: Essential Skills to Succeed as a…
Onboarding is NOT Orientation - How to Improve the New Empl…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Construction Lending And Real Credit Administration: Evalua…
Building GMP Excellence: A Guide to Implementing Compliant …
Improving Employee Engagement & Retention Through Stay Inte…
Understanding cognitive load in medical device design
Human Error Reduction Techniques for Floor Supervisors
Excel Power Skills: Master Functions, Formulas, and Macros …
