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.
Fair Lending in 2025: New Regulations, Examinations and Enf…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Using Emotional Intelligence to Elevate Your Leadership
ChatGPT & HR: How HR Recruiting Professionals Can Leverage …
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
FDA Trends in Compliance and Enforcement in Computer System…
Tattoos, hijabs, piercings, and pink hair: The challenges …
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
How to Write a Successful Job Hazard Analysis
How to Write Right for Better Business Communication
How to Prepare For and Host a FDA Inspection and Respond to…
From Good to Great: The Secrets to an Optimized LinkedIn Pr…
Public Speaking: Overcoming The Fear of Public Speaking
Transforming Anger And Conflict Into Collaborative Problem …
Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
Workplace Investigations 101: How to Conduct your Investiga…
Navigating Alcohol and Drug Addiction Protections Under the…
Reduce Stress in the Workplace: Effective Ways to Handle Co…
Transforming HR with AI: Unlocking Excellence and Innovation
Creating Employee Handbooks that Protect You and Support th…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Transform Data into Insights: A Beginners Guide to Excel Pi…
50+ new Excel features so far this decade
Mindful Communication:The Key to Meaningful Conversations i…
FDA Proposes Framework to Advance Credibility of AI Models
FMLA Compliance in 2025: A Comprehensive Guide & Strategies…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Hiring and Retaining Employees in this Crazy Economy
Managing Toxic Employees: Strategies For Leaders To Effecti…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…