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

FDA has substantial authority to oversee regulated companies and their operations. The primary purpose of the FDA is to ensure 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 its practices and products is through data and documentation, meaning both structured 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 exposes itself to FDA scrutiny and the possibility of 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 examination, an FDA auditor may have observed specific practices and reviewed 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 the FDA is a challenging task, and should be done very carefully.  In this webinar, we’ll focus on the specific best practices required to ensure 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 the FDA’s findings and must be done appropriately.

The attendees will learn about the following key areas:

• 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 Form 483 in the most efficient and effective way
• Form 483 Response Examples from the Industry
• Further, FDA Enforcement Action that may be possible
• Creating a Corrective Action/Preventive Action (CAPA) Plan.

• FDA Inspection
• FDA Form 483
• FDA Warning Letter
• FDA Consent Decree
• Other FDA Actions (Seizures, Injunctions, Criminal Referrals, Fines, etc.)
• Effective Response to Form 483
• Effective Response to a Warning Letter
• Industry Best Practices
• Computer System Validation (CSV)
• Computer Software Assurance (CSA)
• Waterfall Methodology
• Agile Methodology
• System Development Life Cycle (SDLC) Methodology
• GAMP®5 “V” Model
• Q&A.

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 the 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.

Has your firm been issued one or more Form 483s by the 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 the FDA and limit the company’s exposure to further regulatory action, such as a Warning Letter.

• Information Technology Analysts
• Information Technology Developers and Testers
• Software Quality Assurance Professionals
• 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 responsible for software development, testing, and maintenance
• Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance.