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    • Live Courses/Webinars
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HomeManufacturing (GMP)Writing Effective 483 and Warning Letter Responses

Writing Effective 483 and Warning Letter Responses

Teachers
Kelly Thomas
Category:
Manufacturing (GMP)/ On-Demand Courses/ Quality/ Regulatory & Compliance/
Clear
Duration: 90-Minutes
On-Demand
Includes handouts!
  • Description
  • Who Should Attend
  • What To Expect

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 is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

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.

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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Clear
Duration: 90-Minutes
On-Demand
Includes handouts!

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The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

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