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

Instructor: Marc Sanchez
Product ID: 702797
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

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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.

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:

  • Outline of FDA enforcement and compliance scheme.
  • FDA inspection process.
  • Lead up to a warning letter - warning signs.
  • Warning letter issuance.
  • Company response to FDA warning letters.
  • What to avoid when dealing with FDA warning letters.
  • Correcting FDA warning letter closeout mistakes.

Areas Covered in the Seminar:

  • Warning Letter response.
  • Top Ten Findings in Food, Dietary Supplements and Medical Device.
  • Common mistakes when responding to the FDA.
  • What actions to take to demonstrate compliance.

Who Will Benefit:

  • Food & beverage industry executives
  • Dietary Supplement manufacturers/distributors
  • Medical Device manufacturers/distributors
  • In-House Legal Counsel
  • Regulatory Affairs
  • Government Affairs
  • Distributors and manufacturers
  • Customs brokers
  • FDA/Food & Drug Attorneys

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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