Best Approach to Responding to an FDA Inspection Report and Form 483s
Best Approach to Responding to an FDA 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 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 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 the FDA’s findings and must be done appropriately.
Areas Covered:-
Learning Objectives:-
The attendees will learn about the following key areas:
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.
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.
Who will Benefit:-
Any Organization, Institution or Group User can register
Registration Form support@webinaraxis.comDownload the
Order FormAccess Information for Live Session will be emailed to you 12 hours prior the live date.
Access Information for On-Demand, and Transcript will be emailed to you 24 hours post of the live session.
Also, You can access the training information from your dashboard at WebianarAxis.
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, 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.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
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