If you received an FDA 483 inspection observation, make sure you watch this training video before sending your response (within 15 days).
What happens if you miss the FDA’s response deadline for an FDA 483 inspection observation?
This is the first step in responding to an FDA 483 inspection observation. You need to identify the response deadline. You have 15 business days, starting from the date you received the FDA Form 483 from the inspector. This does not include weekends or US Federal Holidays. To make sure, you can confirm the date with the inspector by email or during the closing meeting before the inspector leaves. If you miss the deadline, and the inspection outcome is “Official Action Indicated (OAI),” then your company will automatically receive a Warning Letter. You and your company’s top management should take this deadline seriously. Seek immediate regulatory help if you do not have extensive experience writing corrective action plans.
What does this training cover?
Included are examples, recommendations and tips; for implementing the 7 steps, including:
- Respond within 15 business days
- Use your CAPA form
- How to document a root cause investigation
- Correction and containment
- Corrective action plans
- Show you took action
- Follow up BEFORE the FDA
- Watch our video…
Other related topics reviewed include:
- 8 D Process -“8 Disciplines” to be utilized as a model for an effective CAPA process
- Recalls
- Documentation to include in your CAPA record
- Effectiveness checks (examples)
- Trend analysis
This webinar recording is only $129 (AND INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):
How do I get a training certificate for the FDA 483 training webinar?
When you purchase this webinar, you will receive an email with a link for the training video. At the end of the video, there is a slide that provides you with a link to our quiz to verify training effectiveness. The quiz is available on-demand (24/7), and there is no need to download anything. When you submit your answers to the 10 multiple-choice questions, your quiz will be automatically graded, and you will receive the results. If you answer 7 out of 10 questions correctly, you will receive a training certificate. We also have a 10-question quiz for our Risk-Based CAPA webinar.
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About Your Instructor
Rob Packard is a regulatory consultant with 30+ years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a UConn graduate in Chemical Engineering. Rob was a senior manager at several medical device companies, including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, including implants and drug/device combination products for CE marking applications, Canadian medical device license applications, and 510(k) submissions. The favorite part of his job is training others. He can be reached via phone at +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Facebook.