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.
Accounting For Non Accountants : Debit, Credits And Financi…
Regulation update Q1 2025: New and Proposed Regulations for…
Successful Strategies for FDA Expedited Pathways for Your D…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Pay Transparency in Action: Strategies for Building Trust a…
Designing Employee Experiences to Build a Culture of Compli…
Reinvent Your Business with the Power of AI
Excel Lookup Functions: VLOOKUP, HLOOKUP, and XLOOKUP Made …
Developing and Implementing Quality Culture in the Organiza…
Break Free from Toxicity: Reclaim Your Power and Peace
Tips and Techniques for Conducting an Effective Fraud Risk …
Physician Employment Agreements: Problem Areas that can be …
Measure the Effectiveness of Compliance Programs by Engagin…
FDA Regulation of Artificial Intelligence/ Machine Learning
Computer System Validation (CSV) 3-Hour Boot Camp
Quality Management Systems and Data Integrity
Implementing an Effective Human Error Reduction Program
Cleaning Data without Complex Functions - A Course for Data…
Navigating 2025 Employment Laws: What Every Employer Needs …
Employers Should Prepare for Immigration Raids in 2025! Thi…
Succession Plan for 2025: It's Not Just for Emergencies - I…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Using High-Performance Coaching for Managers to Address Per…
Negotiating Skills For Professional Results - Winning Strat…
21 CFR Part 11 - Compliance for Electronic Records and Sign…
Principles & Practices for the Cybersecurity of Legacy Medi…
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Tattoos, hijabs, piercings, and pink hair: The challenges …
How to Lead and Manage a Narcissistic Manager
Building Thriving Teams: Proactive Strategies for Managers …
ChatGPT and Project Management: Leveraging AI for Project M…
Reduce Stress in the Workplace: Effective Ways to Handle Co…
Stress, Change And Team Resilience Through Humor: An Intera…
The Importance of the first 5 seconds when presenting
GAAP—Update on new Accounting Principles and How They Impac…
Creating Employee Handbooks that Protect You and Support th…
ChatGPT and Project Management: Leveraging AI for Project M…
Female to Female Hostility @Workplace: All you Need to Know
How to Prepare For and Host a FDA Inspection and Respond to…
Onboarding Best Practices for 2025: Proven Strategies to Po…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…