Writing Effective 483 and Warning Letter Responses

Teachers
Kelly Thomas
Category:
Manufacturing/Quality/Regulatory & Compliance/Upcoming Live Courses/
Clear
Duration: 90-Minutes
TBD
Includes handouts!

Description

COURSE DESCRIPTION

OVERVIEW

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.

LEARNING OBJECTIVES

At the completion of this session, you will be able to:

  • Identify timelines and potential regulatory outcomes of not submitting an appropriate response
  • Review the components necessary to develop a thorough response
  • Utilize a response checklist
  • Evaluate recent Regulatory observations and review associated responses
  • Recognize 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
  • Develop post response outcomes

Who Should Attend

WHO SHOULD ATTEND

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:

  • Quality
  • Manufacturing
  • Engineering

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar will be offered live. With your course purchase, you may participate live or view the recording at your convenience (available for 30 days). Access instructions for the live viewing will be emailed to you 3 business days prior to the scheduled date. Access to the recorded version will be available 1 business day after the live course has run.

To access the course, you need only a telephone and computer with internet access.

This webinar is scheduled for live instruction on
Date: TBD
Time: 1:00 – 2:30 PM EDT

Choose to participate live or listen to the recording afterward!

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

The recorded version of the training will be available for 30 days after purchase.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Kelly Thomas
Kelly Thomas | cGMP QA/QC Expert

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