How to Write Effective 483 and Warning Letter Responses
Instructor:
Kelly Thomas
Product ID: 705918
Training Level: Intermediate
- Duration: 90 Min
Why Should You Attend:
Every GMP manufacturing facility will experience a regulatory inspection at some point. If the outcome of the inspection results in a 483 or a Warning Letter, the firm must respond to the agency in a timely and proper fashion in order to avoid additional regulatory action.
Attendees of this course will understand regulatory expectations for firms that have received a 483 or Warning Letters; as well as, the consequences of not providing a proper response. Attendees will learn how to correctly structure and submit the response to ensure the regulatory agency’s expectations are met and the submission process is properly executed.
Areas Covered in the Webinar:
Part 1 – Review regulatory policies and procedures in regard to FDA 483 observations or Warning Letters.
- Understand the importance of responding to the observations
- Discuss timelines and potential regulatory outcomes of not submitting an appropriate response
- Understand who is the audience
- Understand what the regulatory agency is expecting in the response
Part 2 – Structure of the Response
- Review the components necessary to develop a thorough response
- Review response checklist
- Discuss recent Regulatory observations and review associated responses
Part 3 – Response Submission and Post Response Outcomes
- Discuss the process for submitting the response to the regulatory agency
- Discuss when and how to provide follow-up updates to the regulatory agency post the initial response
- Discuss post response outcomes
Who Will Benefit:
- Quality Assurance
- Regulatory Affairs
- Operations Managers
Kelly Thomas
Vice President, Americas Quality Operations
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.
More Training By Experts
- FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
- Annual Current Good Manufacturing Practices (cGMP) Training
- Implementing a Robust and Compliant Change Control Program
- ASTM 2500: Lessons Learned Through a Decade of Implementation
- Implementing a Quality Management System
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
