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

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9780982147658: International Conference on Harmonisation (ICH) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference

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

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About the Author:

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.

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Book Description Pharmalogika 5/22/2010, 2010. Paperback or Softback. Book Condition: New. International Conference on Harmonisation (Ich) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference. Book. Bookseller Inventory # BBS-9780982147658

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Book Description Pharmalogika, United States, 2010. Paperback. Book Condition: New. Language: English . Brand New Book ***** Print on Demand *****. 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. Bookseller Inventory # APC9780982147658

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Book Description Pharmalogika, United States, 2010. Paperback. Book Condition: New. Language: English . Brand New Book ***** Print on Demand *****.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. Bookseller Inventory # APC9780982147658

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Book Description Pharmalogika. Paperback. Book Condition: New. Paperback. 650 pages. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines. ICH Quality Guidelines: Overview and OrientationIntroductionPart 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, Q5EPart VI: Specifications Q6A, Q6BPart VII: Good Manufacturing Practice Q7Part VIII: Pharmaceutical Development Q8(R2)Part IX: Quality Risk Management Q9Part X: Pharmaceutical Quality System Q10Reference ToolsPart XI: Questions and Answers for Q8910 Quality Guidance DocumentsPart XII: Combined Glossary and Index for all Quality Guidance Documents This item ships from multiple locations. Your book may arrive from Roseburg,OR, La Vergne,TN. Paperback. Bookseller Inventory # 9780982147658

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