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

by Mindy J. Allport-Settle (Author)

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

Author Biography

Mindy Allport-Settle has served 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, operational, project and contract management, 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.