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Process analytical technology
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41	Barbara B. Zinck Senior Director Corporate Compliance Direct Line: [removed]x 249 [removed] Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-11-20 08:28:10 Clinical research Food and Drug Administration Pharmacology Design for X Process analytical technology Quality control Cambrex Corporation Center for Biologics Evaluation and Research Pharmaceutical sciences Pharmaceutical industry Medicine
42	Implementation of ICH Q8, Q9, Q10 Breakout D : Pharmacopoieal Requirements and the New ICH Quality Paradigm – Time for a Change? Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 04:05:51 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Pharmacopoeia Kuala Lumpur Alternative medicine Software development process Process analytical technology Form Research Quality Quality by Design Science
43	CDER Regulatory Applications – Investigational New Drug and New Drug Applications Add to Reading List Source URL: www.fda.gov Language: English Quality by Design Design for X Management Quality control Pharmaceutical industry Process analytical technology Product lifecycle management Quality Business Technology
44	“t I Novartis Pharmaceuticals Corporation Global Regulatory CMC One Health Plaza Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-12 11:49:26 Pharmaceuticals policy Pharmacology Clinical research Design for X Process analytical technology Quality control Food and Drug Administration Validation Regulatory requirement Pharmaceutical industry Pharmaceutical sciences Pharmaceutics
45	Groton Laboratories Pfizer Inc Eastern Point Road Groton, CT 06348, Tel 860 44141gO i t: !! Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-08 14:23:24 Clinical research Design for X Process analytical technology Quality control Quality management Pfizer Quality management system Food and Drug Administration Quality assurance Pharmaceutical sciences Pharmaceutical industry Pharmacology
46	BIO Comments to FDA Docket 2003D-0380, p. 2 of 2 Biotechnology Industry Organization Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-08 14:28:57 Environmental biotechnology Process analytical technology Bio Science Technology Business Pharmaceutical industry Biotechnology Validation
47	SMG[removed]FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION FDA OFFICIAL COUNCILS AND COMMITTEES SCOPE OF QUALITY SYSTEM IMPLEMENTATION IN FDA Effective Date: [removed]. Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act Office of Regulatory Affairs Process analytical technology Center for Biologics Evaluation and Research ISO/IEC 17025 Validation Quality by Design Food and Drug Administration Pharmaceutical sciences Medicine
48	DOC Document Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-05 09:20:34 Formal methods Software engineering Geographic information system Validation Software development process Knowledge Process analytical technology Pharmaceutical industry Science Validity
49	ventis November 3,2003 Via fax and UPS Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-08 14:23:29 Management Evaluation Validity Design for X Process analytical technology Validation Quality assurance Specification Software development process Quality Pharmaceutical industry Science
50	PDF Document Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-11-12 17:50:23 Pharmacology Validation Process analytical technology Purdue Pharma Title 21 CFR Part 11 Food and Drug Administration Quality assurance Pharmaceutical industry Pharmaceutical sciences Pharmaceutics

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