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FDA Warning Letters - Stop Fumbling your Response and Effectively Demonstrate Compliance

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This training will outline the best practices in responding to a FDA Warning Letter so the consequences of the findings do not escalate beyond the current status.

Instructor: Marc Sanchez
Product ID: 702797
Training Level: Intermediate to Advanced

Why Should You Attend:

Many industry 483 observations shouldn't have been received at all. Most Warning Letters could have been easily prevented. Yet the last few years have seen several major "names" in drugs, devices, and food stumble over GMP issues, resulting in recalls, lawsuits, and even possible criminal prosecution. If 483's are received, how can Warning Letters be avoided? If a warning letter is received, how can you demonstrate compliance to the FDA? How to address FDA District and Center concerns?

During this webinar, you will learn:

Areas Covered in the Seminar:

Who Will Benefit:

Instructor Profile:

Marc C. Sanchez, practices medical device and food law and is best known for working to build regulatory strategies for start-up and small to midsize companies in the US, Europe and China. His educational and work portfolios are rooted in law and business management. He began his career with the legal division at Nike’s European headquarters, heading up product recalls, pricing and digital privacy in the EU, US, China and Japan. He later began his own practice in Seattle, focusing on product recalls, regulatory compliance and employment law.

In 2011, Marc founded Contract In-House Counsel and Consultants, LLC to offer a broad range of services to the medical device and food industry. He currently serves clients across the US, EU, China and Middle East. Marc received a masters in international commercial policy from Valparaiso University and earned his JD from Lewis and Clark College. He is a member of the Washington Bar Association and the Regulatory Affairs Professionals Society.

Topic Background:

Inspections by the FDA are perhaps the most intimidating of all events at a regulated facility. There are also the most common with the FDA conducting thousands of inspections each year, Most if not all of these lead to Inspectional Findings or Form 483. A fumbled 483 response leads to a warning letter, which can lead to serious consequences.

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Refund Policy
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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COSO Framework for Internal Controls, Risk Assessment and Financial Statement Audit - 80225SEM

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Training Options Training Duration = 60 Min
$199.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$399.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days