{"product_id":"international-conference-on-harmonisation-ich-quality-guidelines-pharmaceutical-biologics-and-medical-device-guidance-documents-concise-reference-9780982147658","title":"International Conference on Harmonisation (ICH) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference","description":"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\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Mindy J. Allport-Settle\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Pharmalogika\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 05\/22\/2010\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 650\u003cbr\u003e\u003cb\u003eBinding Type:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.89lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.02h x 5.98w x 1.31d\u003cbr\u003e\u003cb\u003eISBN:\u003c\/b\u003e 9780982147658\u003cbr\u003e\u003cp\u003e\u003cb\u003eAbout the Author\u003c\/b\u003e\u003cbr\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.\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e\u003ci\u003eThis title is not returnable\u003c\/i\u003e\u003cbr\u003e\u003c\/p\u003e","brand":"Pharmalogika","offers":[{"title":"Paperback","offer_id":40445916938355,"sku":"9.78E+12","price":63.66,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0555\/9255\/0515\/products\/img_e04c40d0-b384-4c13-8bf9-b0d26cf99ee0.jpg?v=1663426742","url":"https:\/\/bookstorenmore.com\/products\/international-conference-on-harmonisation-ich-quality-guidelines-pharmaceutical-biologics-and-medical-device-guidance-documents-concise-reference-9780982147658","provider":"Bookstore N More","version":"1.0","type":"link"}