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

Overview:

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 in the session:

In this webinar, we’ll discuss the following areas:

• FDA Regulatory Oversight
• FDA Inspection Types
• FDA Form 483
• FDA Form 483 Citations
• Responding to a Form 483
• Form 483 Response Examples
• Further FDA Enforcement Action
• Corrective Action/Preventive Action (CAPA) Plan
• Q&A

Why should you attend?

1. Has your firm been issued one or more Form 483s by FDA?
2. 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.

What industries will benefit from your training?

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:

• Pharmaceutical (for drug products introduced using a medical device)
• Medical Device
• Biologicals (for biological products introduced using a medical device)
• Tobacco (based on the Tobacco Control Act of 2009)
• E-Liquid/Vapor (based on the “Deeming” Act of 2016)
• E-Cigarette (based on the “Deeming” Act of 2016)
• Cigar (based on the “Deeming” Act of 2016)
• Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
• Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA

Who will benefit?

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors engaged in the internal inspection of labeling records and practices