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WRITING EFFECTIVE 483 AND WARNING LETTER RESPONSES

By: Kelly Thomas

24 April, 2023 (Monday)

Duration: 90 Minutes

Timing: 12:00 PM PDT | 03:00 PM EDT

Countdown:

 * 11 : Days
 * 01 : Hrs
 * 41 : Min
 * 50 Sec

 * OVERVIEW
 * LEARNING OBJECTIVES
 * WHO WILL BENEFIT?

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 WILL BENEFIT?

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




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

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

  Download Brochure   Set Email Reminder



Live Webinar Options:
(Live Session for 1 Participant)
Live Session ($199)


INCREASE PARTICIPANTS

1 Participants $199 2 Participants $299 3 Participants $399 4 Participants $449
5 Participants $499 6 Participants $549 7 Participants $599
(Live + Recorded Session)
Super Jumbo Offer ($269)
(Live + Transcript)
Live + Transcript ($249)
(Live + Training CD)
Super Jumbo Offer ($450)
On Demand Options:
(PDF Transcript of Training)
Transcript ($179)
(Downloadable Recorded session)
Recorded session ($239)
(Training CD)
Training CD ($350)
Group Session Options:
(Group Session Participants + Recorded)
Group Session for 10 Participants($799)

For adding extra attendees please contact our Customer Support Team


$


For multiple location please contact our customer care team Tel:+1-661-336-9555

April 13, 2023

Form 1099 Update 2023: Latest Forms, Rules and Reporting Regulations

Patrick Haggerty

SPEAKER PROFILE



Kelly Thomas
View All Webinars

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.



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