{"product_id":"international-conference-on-harmonisation-ich-quality-guidelines-pharmaceutical-biologics-and-medical-device-guidance-documents-concise-reference-paperback","title":"International Conference on Harmonisation (ICH) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference - Paperback","description":"\u003cdiv\u003e\u003cp style=\"text-align: right;\"\u003e\u003ca href=\"https:\/\/reportcopyrightinfringement.com\/\" target=\"_blank\" rel=\"nofollow\"\u003e\u003cb\u003eReport copyright infringement\u003c\/b\u003e\u003c\/a\u003e\u003c\/p\u003e\u003c\/div\u003e\u003cp\u003eby \u003cb\u003eMindy J. Allport-Settle\u003c\/b\u003e (Author)\u003c\/p\u003e\u003cp\u003eICH 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\u003c\/p\u003e\u003ch3\u003eAuthor Biography\u003c\/h3\u003e\u003cp\u003eMindy 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.\u003c\/p\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003eNumber of Pages:\u003c\/strong\u003e 650\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003eDimensions:\u003c\/strong\u003e 1.31 x 9.02 x 5.98 IN\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003ePublication Date:\u003c\/strong\u003e May 22, 2010\u003c\/div\u003e\n            ","brand":"BooksCloud","offers":[{"title":"Default Title","offer_id":52239311667474,"sku":"9780982147658","price":60.73,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0941\/2211\/5346\/files\/V1VkSVVoRzZ4ZDhRdG9qbGY4ZXBtUT09.webp?v=1777875839","url":"https:\/\/ckbookstore.net\/products\/international-conference-on-harmonisation-ich-quality-guidelines-pharmaceutical-biologics-and-medical-device-guidance-documents-concise-reference-paperback","provider":"CK BOOKSTORE","version":"1.0","type":"link"}