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Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

  • CISA
  • CPA (US)
  • CISM
  • CRISC
  • CDPSE
  • ITCA
  • Course Description
  • Course Qualification
  • Presenter
  • Faq

Course Description

Course Description

Has your firm been issued one or more Form 483s by FDA?

Are you concerned about writing a successful response?

This CPE webinar will provide you with the best practices for writing a solid response that will be well-received by FDA and limit the company’s exposure to further regulatory action, such as a Warning Letter.

FDA has substantial authority to oversee regulated companies and their operations. The primary purpose of the FDA is to assure safe and effective products that will protect public health. Violations can have seriously adverse effects on products, and ultimately, on patients and consumers.

The root of every company’s efforts to defend their practices and products is through data and documentation, meaning both structure data (database) and unstructured data (documents, spreadsheets, presentations, audio, video, etc.). Computer systems used to house, collect, modify, analyze, report, transfer, or otherwise manage both structured and unstructured data must be validated in accordance with FDA requirements to assure data integrity. By not doing so, a company leaves itself exposed to FDA scrutiny and the possibility of a Form 483 citations, or even more severe consequences.

Since 1953, FDA has been provided with the authority to conduct formal inspections of regulated companies, both announced and unannounced. During the inspection, an FDA auditor may have observed specific practices and/or review specific data/documentation that is out of compliance with regulations. 

In this CPE webinar, we will provide the most frequently cited issues to enable your company to get ahead of the curve and avoid a similar fate.

Based on the observed findings, the auditor may provide a Form 483 citation, indicating the company has 15 days to respond if the response is to be considered when determining whether further action is needed.

If the response is not adequate, this may lead to further enforcement action, which can be very costly and time-consuming. We will guide avoiding such a situation, or at least minimizing it. Writing an effective response that will minimize the possibility of further action by the FDA is a challenging task, and should be done very carefully.

In this CPE webinar, we’ll focus on the specific best practices required to assure an adequate response. We will also review examples of good and bad responses to gain more insight and direction for creating one.

Finally, we will provide an overview and the key components of a good CAPA program.  The CAPA is at the heart of a company’s response to FDA’s findings and must be done appropriately.

Learning Objectives

  • To discuss FDA oversight and regulations for compliance.
  • To analyze how FDA operates and the tools they have available to them.
  • To discuss FDA inspection types.
  • To analyze the Form 483 citation and what it means.
  • To discuss the best practices for responding effectively to an FDA Form 483.
  • To analyze current trends in FDA compliance and enforcement as they relate to issues and citations.
  • To analyze industry best practices that will lead to inspection readiness and effectively respond to Form 483 citations.
  • To explain the potential for further regulatory action by not responding effectively to Form 483.
  • To inspect the CAPA process and how to effectively create a CAPA program, form, and procedure.

Recommended For

  • This CPE webinar is recommended for CPAs, CISA, CISM, CRISC, and all the titles of ISACA who want to understand Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA.

Who Should Attend?

  • CPA (Industry)
  • CPA - Mid Size Firm
  • CPA - Small Firm
  • Young CPA

Course Qualification

Webinar Qualifies For

  • 1.5 CPE Credit for Certified Data Privacy Solutions Engineer (CDPSE)
  • 1.5 CPE Credit for Certified in Risk and Information System Control (CRISC)
  • 1.5 CPE Credit for Certified Information Security Manager (CISM)
  • 1.5 CPE Credit for Certified Information Systems Auditor (CISA)
  • 1 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
  • 1.5 CPE Credit for Information Technology Certified Associate (ITCA)

Presenter

About Presenter

Carolyn Troiano

Account Executive BrainStorm Central Consulting LLC

Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries.  She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

Faq

FAQs content

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Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

$15

1.5 Credits

Subject Area

Information Technology