International Conference on Harmonisation (ICH) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference

International Conference on Harmonisation (ICH) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference

by Mindy J. Allport-Settle
     
 
ICH Quality Guidelines:
* Overview and Orientation
* Introduction
* Part I: Stability [Q1A(R2), Q1B, Q1C, Q1D, Q1E]
* Part II: Analytical Validation [Q2(R1)]
* Part III: Impurities [Q3A(R2), Q3B(R2), Q3C(R4)]
* Part IV: Pharmacopoeias (List Overview)
* Part V: Quality of Biotechnological Products [Q5A(R1), Q5B, Q5C, Q5D

Overview

ICH Quality Guidelines:
* Overview and Orientation
* Introduction
* Part I: Stability [Q1A(R2), Q1B, Q1C, Q1D, Q1E]
* Part II: Analytical Validation [Q2(R1)]
* Part III: Impurities [Q3A(R2), Q3B(R2), Q3C(R4)]
* Part IV: Pharmacopoeias (List Overview)
* Part V: Quality of Biotechnological Products [Q5A(R1), Q5B, Q5C, Q5D, Q5E]
* Part VI: Specifications [Q6A, Q6B]
* Part VII: Good Manufacturing Practice [Q7]
* Part VIII: Pharmaceutical Development [Q8(R2)]
* Part IX: Quality Risk Management [Q9]
* Part X: Pharmaceutical Quality System [Q10]
Reference Tools
* Part XI: Questions and Answers for Q8/9/10 Quality Guidance Documents
* Part XII: Combined Glossary and Index for all Quality Guidance Documents

Product Details

ISBN-13:
2940011815881
Publisher:
PharmaLogika
Publication date:
05/22/2010
Sold by:
Barnes & Noble
Format:
NOOK Book
Pages:
650
File size:
1 MB

Meet the Author

Following in the footsteps of Gordon Allport, all of Mindy J. Allport-Settle's books are built on a foundation of psychology and sociology with a focus on improving some aspect of industry through research and education.

Her career in healthcare began when she was a teenager working as an emergency medical technician. Since then, she has joined the U.S. Navy's advanced hospital corps, worked in organ and human tissue procurement, specialized in ophthalmology, and moved on to serve as a key executive, board member, and consultant for some of the best companies in the pharmaceutical, medical device, and biotechnology industry. She has provided guidance in regulatory compliance, corporate structuring, restructuring and turnarounds, new drug submissions, research and development and product commercialization strategies, and new business development. Her experience and dedication have resulted in international recognition as the developer of the only FDA-recognized and benchmarked quality systems training and development business methodology.

Her education includes a Bachelor's degree from the University of North Carolina, an MBA in Global Management from the University of Phoenix, and completion of the corporate governance course series in audit committees, compensation committees, and board effectiveness at Harvard Business School.

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