FDA Warning Letters About Food Products: How to Avoid or Respond to Citations
FDA Warning Letters About Food Products: How to Avoid or Respond to Citations uses examples of FDA warning letters about food products as training tools to discuss important quality and manufacturing issues encountered by food companies around the world as they bring food products into the US market. Focused specifically on FDA warning letters surrounding new dietary ingredients and dietary supplements, the book first introduces FDA warning letters in general. Each chapter then focuses on specific issues identified, including HAACP/quality systems, imports/exports, food contact issues, etc. This book helps the food industry train professional team members (across the spectrum of experience levels) to avoid common issues often cited in warning letters. It serves both as an authoritative reference on the common types of warning letters issued to food companies today, and as a guide to best practices for food manufacturers. - Includes a range of specific warning letters as case studies and examples of method application - Synthesizes often complex information into a clear presentation of FDA warning letters and how to deal with them - Describes techniques and methodologies to guide readers to the solution most appropriate for their scenario
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FDA Warning Letters About Food Products: How to Avoid or Respond to Citations
FDA Warning Letters About Food Products: How to Avoid or Respond to Citations uses examples of FDA warning letters about food products as training tools to discuss important quality and manufacturing issues encountered by food companies around the world as they bring food products into the US market. Focused specifically on FDA warning letters surrounding new dietary ingredients and dietary supplements, the book first introduces FDA warning letters in general. Each chapter then focuses on specific issues identified, including HAACP/quality systems, imports/exports, food contact issues, etc. This book helps the food industry train professional team members (across the spectrum of experience levels) to avoid common issues often cited in warning letters. It serves both as an authoritative reference on the common types of warning letters issued to food companies today, and as a guide to best practices for food manufacturers. - Includes a range of specific warning letters as case studies and examples of method application - Synthesizes often complex information into a clear presentation of FDA warning letters and how to deal with them - Describes techniques and methodologies to guide readers to the solution most appropriate for their scenario
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FDA Warning Letters About Food Products: How to Avoid or Respond to Citations

FDA Warning Letters About Food Products: How to Avoid or Respond to Citations

by Joy Frestedt PhD
FDA Warning Letters About Food Products: How to Avoid or Respond to Citations
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FDA Warning Letters About Food Products: How to Avoid or Respond to Citations

FDA Warning Letters About Food Products: How to Avoid or Respond to Citations

by Joy Frestedt PhD

Overview

FDA Warning Letters About Food Products: How to Avoid or Respond to Citations uses examples of FDA warning letters about food products as training tools to discuss important quality and manufacturing issues encountered by food companies around the world as they bring food products into the US market. Focused specifically on FDA warning letters surrounding new dietary ingredients and dietary supplements, the book first introduces FDA warning letters in general. Each chapter then focuses on specific issues identified, including HAACP/quality systems, imports/exports, food contact issues, etc. This book helps the food industry train professional team members (across the spectrum of experience levels) to avoid common issues often cited in warning letters. It serves both as an authoritative reference on the common types of warning letters issued to food companies today, and as a guide to best practices for food manufacturers. - Includes a range of specific warning letters as case studies and examples of method application - Synthesizes often complex information into a clear presentation of FDA warning letters and how to deal with them - Describes techniques and methodologies to guide readers to the solution most appropriate for their scenario

Product Details

ISBN-13: 9780128093504
Publisher: Elsevier Science & Technology Books
Publication date: 08/29/2017
Sold by: Barnes & Noble
Format: eBook
Pages: 334
File size: 15 MB
Note: This product may take a few minutes to download.

About the Author

Joy Frestedt Is the President and CEO for Frestedt Incorporated, a consulting group of over 70 experts providing services in broad CRQE areas of clinical trial development and execution, as well as US and international regulatory compliance, management of corporate quality systems, and biomedical engineering. She has managed clinical research, regulatory affairs, and quality systems for more than 40 years and has published more than 100 manuscripts, as well as book chapters. With a PhD in Pathobiology from the University of Minnesota Medical School, her experience includes designing, conducting and overseeing clinical trials as well as negotiating regulatory submissions and developing quality systems for companies like the University of Minnesota, Orphan Medical, Astra Zeneca Pharmaceuticals, Johnson and Johnson, Medtronic, and Mayo Clinical Trial Services.

Table of Contents

1. History of Warning Letters to Food Companies2. Introduction to Quality Systems3. HAACP4. Imports/Exports5. Food Contact Products6. Clinical Trials for Foods and Dietary Supplements7. Food Safety Modernization Act8. Future Trends and Directions

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Presents examples of FDA warning letters on foods as training tools to identify important quality and manufacturing issues for food companies

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