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The Top 5 FDA Violations & How to Prevent Them

Watch our discussion on how to react to FDA violations and how to prevent them from the beginning.

This free webinar addresses the top violations cited by FDA Inspectors in the following industries:

• Medical device
• Pharma / Drug / OTC

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What you’ll learn / gain from this webinar:

1. What are the most common cited infractions and FDA violations
2. How to prevent the infractions from occurring in YOUR business and QMS with FDA consulting
3. How to respond to a 483 Letter
4. How to respond to an FDA Warning Letter

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Who should watch:

1. Company owners. You are ultimately responsible for the QMS, including the safety and effectiveness of the device/products.
2. Medical Device Manufacturing Leadership. You will learn how to proactively prevent regulatory infractions.
3. Drug and Pharma Manufacturing Leadership. You will learn how to proactively prevent regulatory infractions.
4. VP of Regulatory/Quality. You will most likely be assigned to remedy or fix the problem. Learn how to respond to an FDA 483 and Warning Letter.
5. Management Representatives. You are responsible for ensuring that Quality System requirements are effectively established and maintained.
6. Quality Assurance Personnel. You will most likely be tasked to verify that the QMS has been reviewed and approved for adequacy prior to being issued.
7. CAPA Administrators and Process Owners. You will most likely be tasked to determine the root cause(s) of the nonconformities.
8. Complaint Coordinators. Poor complaint documentation is one of the FDA’s foremost findings. Learn how to solve the problem, not just patch it.
9. Anyone involved with resolving the problem to avoid future FDA Inspection findings!

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About the Host:

Markus Gee has 30+ years of industry experience in Quality System implementation & management with the ISO 9001 and ISO 13485 standards. This includes product development, validations of processes and products, etc. Markus’s auditing experiences help relay what you can do to react to FDA violations and how to prevent them in the first place.