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

  • Accountant
  • CISA
  • CPA/CITP
  • CPA (US)
  • CFIRS
  • CWS
  • 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 Information Systems Auditor (CISA)
  • 1.5 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
  • 1.5 CPD Credit for Certified Information Technology Professionals (CITP)
  • 1.5 CE Credit for Certified Fiduciary & Investment Risk Specialist (CFIRS)
  • 1.5 CE Credit for Certified Wealth Strategist (CWS)
  • 1.5 General Credit for Accountant/Bookeeper

Additional details

  • Course Level :
    Basic
  • Credits :
    1.5
  • Instructional Method :
    Group Internet Based
  • Pre-requisites :
    None
  • Advance Preparation :
    None

NASBA APPROVED

MY-CPE LLC, 1600 Highway 6 south, suite 250, sugar land, TX, 77478

MY-CPE LLC (Sponsor Id#: 143597) is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.NASBARegistry.org.

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.

About Company

BrainStorm Central Consulting LLC

BrainStorm Central Consulting is the leader and premier catalyst for moving companies to a new level by outstripping conventional wisdom and thought, and creating a strategy that goes beyond the realm of “better, faster, cheaper”.


"Our experience will lead you to us, your experience will keep you coming back..."


FDA Compliance Training Topics Offered:

• Developing a Strategic Approach to FDA Compliance for Computer Systems

• FDA’s Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

• Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

• Medical Device Industry Trends for Computer Systems Regulated by FDA

• Tobacco and Related Industry Trends for Computer Systems Regulated by FDA

• FDA Deeming Rule for Tobacco Related Products and Recent Actions: eCigarettes, eLiquids, Cigars

• FDA Compliance and Mobile Applications

• Good Documentation Practices to Support FDA Computer System Validation

• In-Depth Computer System Testing of Computer Systems Regulated by FDA

• Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

• Data Integrity and Governance for Computer Systems Regulated by FDA

• Trends in FDA Compliance and Enforcement for Regulated Systems

• Best Practices in Preparation for an FDA Computer System Audit

• Functional System Requirements for Computer Systems Regulated by FDA

• Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

• 21 CFR Part 11 (e-Records/Signatures) Compliance for Computer Systems Regulated by FDA

• C-TPAT Compliance for FDA-Regulated Industries

• Medical Device Cybersecurity and FDA Compliance

• 21st Century Cures Act and Medical Device Software Compliance

• Medical Device Software 62304 Compliance

• Creating, Reviewing & Managing Audit Trails: Compliance for FDA-Regulated Computer Systems

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

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

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