Full length book by Dr. Joy Frestedt.
With Food and Drug Administration becoming more involved with United States businesses, Warning Letters are issued more often and require immediate response. How to respond and what to do may not be obvious if you’ve never been exposed to a warning letter before. This unique reference book lays out guidelines to learn from the mistakes of others. Readers will understand current trends in Warning Letters, gain insight to real life examples to avoid or to recover and survive and after receiving a Warning Letter.
This 2016 reference guide provides examples of drug and device Warning Letters citing significant deviations from the regulations including:
- Failure to establish appropriate quality systems
- Failure to document corrective and preventive action plans
- Failure to maintain appropriate records
(e.g., complaints, testing, training)
- Failure to follow clinical trial protocols
(e.g., subject inclusion/exclusion, deviations)
- Failure to properly monitor a clinical investigation
- Inadequate drug or medical device accountability
- And MANY others!
Warning Letters – 2016 Reference Guide is a great training tool to develop a deeper understanding of topics related to solving regulatory non-compliance issues and business integration plans for drug and device global markets.
This book will be helpful to “managers, directors, younger CRC’s, (and) other people for training operations.” The book answers questions like “Who’s getting WL and why – software, electronic capabilities, electronic systems validations (future trends)” and gives answers to “questions you can’t answer.”– Director, Clinical Affairs
“If I got a warning letter, I would hire you to fix it!”– Director, Clinical Affairs
“This book will be a great tool for any company currently holding a warning letter.”
Readers have begun to ask intriguing questions like “Why do manufacturing sites get more warning letters?” and discussion centered on clinical trials having protocols, ICFs, INDs and IRBs with lots of oversight by external reviewers – manufacturing does not have these types of plans and reviews.– Director, Clinical Affairs
About the Author
Dr. Frestedt is President and CEO of Frestedt Incorporated, a network of highly skilled staff meeting specific needs in regulatory, clinical and quality affairs. Dr. Frestedt has also founded Alimentix, the Minnesota Diet Research Center to run clinical trials for food-related products, non-significant risk devices and over-the-counter drugs. She has more than 35 years of scientific, clinical and regulatory experience in the health care, pharmaceutical, medical device and food-related industries assisting firms with strategic decisions on a global scale. Dr. Frestedt has been named one of the “100 Most Inspiring People in the Life Sciences Industry” by PharmaVOICE and one of the top 25 “Industry Leaders” a “Women in Business Award” by the Minneapolis/St. Paul Business Journal in 2011.