Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA
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Speaker : CAROLYN TROIANO
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When : Wednesday, December 11, 2024
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Time : 03 : 00 PM EST
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Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid and other FDA-regulated industries.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
FDA has substantial authority to oversee regulated companies and their operations. The primary purpose for 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 effort 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, and FDA auditor may have observed specific practices and/or review specific data/documentation that is out of compliance with regulations. In this webinar, we will provide the most frequently cited issues to enable your company to get ahead of the curve and avoid a similar fate.
Writing an effective response that will minimize the possibility of further action by FDA is a challenging task, and should be done very carefully. In this 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.
Areas Covered
- FDA Regulatory Oversight – what to expect during an inspection
- FDA Inspection Types – 8 types in order of severity
- FDA Form 483 – What it contains, what to look out for, key elements
- FDA Form 483 Citations (Examples)
- Responding to a Form 483 in the most efficient and effective way
- Form 483 Response Examples from industry
- Further FDA Enforcement Action that may be possible
- Creating a Corrective Action/Preventive Action (CAPA) Plan
- Q&A
Course Level- Intermediate
Who Should Attend
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Specialists and Managers
- Supply Chain Specialists and Managers
- Regulatory Affairs Specialists
- Regulatory Submissions Specialists
- Risk Management Professionals
- Clinical Data Analysts
- Clinical Data Managers
- Clinical Trial Sponsors
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Vendors and consultants working in the life sciences industry who are involved in computer system development, implementation, testing, validation, maintenance and compliance
Why Should You Attend
Has your firm been issued one or more Form 483s by FDA?
Are you concerned about writing a successful response?
This 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.
Topic Background
At the conclusion of an FDA inspection, and based on the observed findings, the auditor may provide a Form 483 citation, indicating the company has 15 days to provide a response, 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 provide guidance for avoiding such a situation, or at least minimizing it by writing an effective Form 483 response to FDA.
The response takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.
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$199.00
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