標(biāo)題: Titlebook: Essential Elements for a GMP Analytical Chemistry Department; Thomas Catalano Book 2013 Springer Science+Business Media New York 2013 GMP. [打印本頁(yè)] 作者: Iridescent 時(shí)間: 2025-3-21 18:08
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作者: Intact 時(shí)間: 2025-3-21 23:49
Essential Elements for a GMP Analytical Chemistry Department作者: Inculcate 時(shí)間: 2025-3-22 04:08 作者: 乞丐 時(shí)間: 2025-3-22 06:44
Book 2013ment. This book will serve as a valuable asset to the many companies required to perform GMP analytical method development, validation, analyses etc including?start-up, virtual, and generic pharmaceutical companies. ?作者: Paleontology 時(shí)間: 2025-3-22 12:18
Thomas CatalanoDescribes a systematic approach to establishing an effective GMP analytical department.Discusses the development and management of project teams.Describes an outsourcing process to ensure all activiti作者: ALIBI 時(shí)間: 2025-3-22 16:38
http://image.papertrans.cn/e/image/315435.jpg作者: ALIBI 時(shí)間: 2025-3-22 18:31
978-1-4899-9674-9Springer Science+Business Media New York 2013作者: BROTH 時(shí)間: 2025-3-23 01:11
https://doi.org/10.1007/978-1-4614-7642-9GMP; SOP; operating guidance; regulatory guidance作者: Electrolysis 時(shí)間: 2025-3-23 05:00
Studies in Computational Intelligenceical Chemistry Department to function as an efficient and effective organization. The structure of the department needs have the necessary processes available to all its personnel and the department must be structured in a way where there is a free flow of information and interaction. The isolation 作者: 滑稽 時(shí)間: 2025-3-23 06:18 作者: 得意人 時(shí)間: 2025-3-23 12:58
Sebastiano B. Serpico,Gabriele MoserTechnology, and Department. Each of the processes included are described in enough detail to be directly implement. Several of the process flow charts are shown along with examples of implementing the processes. The technical processes described are HPLC and Dissolution method development, Method Va作者: 沒(méi)收 時(shí)間: 2025-3-23 14:11
Giovanni Acampora,Autilia Vitiellofy and briefly review those concepts such as, significance, confidence intervals, uncertainty in measurements, design of experiments, etc. that are critical for the analytical chemist to understand so that they can discuss the data with company and regulatory agency statisticians and ensure that the作者: Talkative 時(shí)間: 2025-3-23 20:32
Philip Moore,Mike Jackson,Bin Hupecific area, or may have certain resource capability gaps that require the need for outsourcing. Others may be seeking novel technology or unique capabilities offered by an outsource provider. Tight timelines, competing priorities, or the need to allocate resources for other strategic purposes may 作者: ATP861 時(shí)間: 2025-3-23 22:20
Xiaobei Jiang,Wuhong Wang,Klaus Benglerannot be obtained. The old expression “If it’s not Documented it’s not Done” is well suited in a GMP/Regulatory environment. Included in this chapter are templates for several of the important documents that must available in an Analytical Department. Those described herein are Sample Submission, Te作者: STERN 時(shí)間: 2025-3-24 03:54
Shaheen Ahmad,Muhammad Abul Hassanne Testing and Validation, Scientist tracts and Team Leader tracts may exist. Each of these tracts must be clearly described along with the levels within the tracts, so that personnel have a clear vision for a potential career path. Care must be taken so that each tract has a minimum overlap so that作者: 群居男女 時(shí)間: 2025-3-24 07:01 作者: falsehood 時(shí)間: 2025-3-24 12:51 作者: Affectation 時(shí)間: 2025-3-24 16:27
Introduction,ical Chemistry Department to function as an efficient and effective organization. The structure of the department needs have the necessary processes available to all its personnel and the department must be structured in a way where there is a free flow of information and interaction. The isolation 作者: 不理會(huì) 時(shí)間: 2025-3-24 22:59
Organization,s based on a project team model. Discussions on how the team is formed, managed, and the utilization of team dynamics are presented in detail. A process for project risk evaluation based on the project plan is proposed. Among the most basic essentials, and a requirement, in any successful GMP Analyt作者: 腫塊 時(shí)間: 2025-3-25 01:51 作者: 在前面 時(shí)間: 2025-3-25 04:37 作者: Audiometry 時(shí)間: 2025-3-25 10:39 作者: WATER 時(shí)間: 2025-3-25 14:37 作者: 隼鷹 時(shí)間: 2025-3-25 18:38
Job Descriptions,ne Testing and Validation, Scientist tracts and Team Leader tracts may exist. Each of these tracts must be clearly described along with the levels within the tracts, so that personnel have a clear vision for a potential career path. Care must be taken so that each tract has a minimum overlap so that作者: Uncultured 時(shí)間: 2025-3-25 21:52 作者: engrave 時(shí)間: 2025-3-26 04:02 作者: Pigeon 時(shí)間: 2025-3-26 04:26 作者: 偽善 時(shí)間: 2025-3-26 10:55
Introduction,vailable to all its personnel and the department must be structured in a way where there is a free flow of information and interaction. The isolation and hording of ideas, skills and abilities should be discouraged and the sharing and helping each other should be rewarded.作者: Definitive 時(shí)間: 2025-3-26 15:25 作者: 憲法沒(méi)有 時(shí)間: 2025-3-26 19:26 作者: 敲竹杠 時(shí)間: 2025-3-26 22:08 作者: AGATE 時(shí)間: 2025-3-27 02:28
Philip Moore,Mike Jackson,Bin Hu approach to outsourcing. In this chapter an outsourcing process is described which can be applied to small and large companies alike. The flow charts describing the process and the documentation needed are included so that a clear and complete understanding can be obtained.作者: 火花 時(shí)間: 2025-3-27 06:44
Outsourcing, approach to outsourcing. In this chapter an outsourcing process is described which can be applied to small and large companies alike. The flow charts describing the process and the documentation needed are included so that a clear and complete understanding can be obtained.作者: Dorsal-Kyphosis 時(shí)間: 2025-3-27 11:07 作者: LATHE 時(shí)間: 2025-3-27 17:27
Studies in Computational Intelligencevailable to all its personnel and the department must be structured in a way where there is a free flow of information and interaction. The isolation and hording of ideas, skills and abilities should be discouraged and the sharing and helping each other should be rewarded.作者: 繼而發(fā)生 時(shí)間: 2025-3-27 19:08 作者: 斗志 時(shí)間: 2025-3-27 22:43 作者: AORTA 時(shí)間: 2025-3-28 06:06 作者: Indent 時(shí)間: 2025-3-28 08:26 作者: NAV 時(shí)間: 2025-3-28 14:04
https://doi.org/10.1007/978-981-19-2519-1usiness. Included in this chapter is a promotion process flow diagram and promotion template which will project a clear understanding of the process and what must be accomplished. In addition an example of a mentoring program is outlined which demonstrate the activities and discussions that should be considered.作者: Tracheotomy 時(shí)間: 2025-3-28 18:07
Sabeur Lafi,Ammar Kouki,Jean Belzilevior during the interviewing process, and the interpretation of candidate facial and body language responses. Also included are documents that aid in the collection of information to enable a comprehensive evaluation of the candidate.作者: PLE 時(shí)間: 2025-3-28 20:47
Organization,unicate best practices within the group. The essential SOP’s that should be included within a GMP Analytical Chemistry Department is listed within the chapter, along with a template for writing SOP’s.作者: vanquish 時(shí)間: 2025-3-28 23:13
