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.
Female to Female Hostility @Workplace: All you Need to Know
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
2-Hour Virtual Seminar on Empowering Presentations with Pow…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Understanding Artificial Intelligence (AI) & using Chat GPT
Creating Loyal Customers Through Excellent Customer Service
Understanding and Communication New Immigration Policies (2…
Navigating Talent Management and Retention Strategies.
HIPAA is Unsettled – Safe Compliance Strategies
Project Management for Non-Project Managers - Scheduling yo…
How to Prepare For and Host a FDA Inspection and Respond to…
Empowering Conflict Resolution: Letting Go to Gain Control
Onboarding Best Practices for 2025: Proven Strategies to Po…
Navigating 2025 Employment Laws: What Every Employer Needs …
Managing Toxic Employees: Strategies For Leaders To Effecti…
How to Conduct Exit Interviews - Implementing and Enhancing…
Adapting to Change: Strategies for Personal & Team Resilien…
Introduction to Excels Built-In Solver – Advanced Decision-…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Design Control for Medical Devices Including Verification/V…
Stress, Change And Team Resilience Through Humor: An Intera…
Developing and Implementing Quality Culture in the Organiza…
GROUPBY and PIVOTBY functions. Pivot table killers?
Negotiating Skills For Professional Results - Winning Strat…
Use the power of AI to turbocharge your MS Excel
Trust in Leadership: Building and Maintaining Trust as a Le…
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
AI and Human Resources: The Great Opportunity!
Tools and Tactics for Grieving, Surviving, and Thriving in …
Bootcamp for New Managers and Supervisors: Develop These Es…
How To Conduct An Internal Harassment And Bullying Investig…
How Generative AI can be used in Banking Risk and Compliance
Creating Employee Handbooks that Protect You and Support th…
Excel Power Skills: Master Functions, Formulas, and Macros …
Emotional Intelligence: Mastering the Emotions of Great Lea…
Managing Toxic & Other Employees Who Have Attitude Issues
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
SOPs - How to Write Them to Satisfy those Inspectors
Improving Employee Engagement & Retention Through Stay Inte…
How to Give Corrective Feedback: The CARE Model - Eliminati…