prosys-llc.com
Business Value Through Information Technology
http://www.prosys-llc.com/Publications.htm
Describes post-merger business and systems integration from a process point of view. Paper developed for and published in Bâtisseurs d'Alliances by Jean-Pierre Guth. Your Systems Project is not a Systems Project. The 10 DOs in Selecting and Implementing Innovative Information Technology. Presented at the DIA. Annual Meeting, Baltimore. Readying Business Processes For Major Systems Rollouts. Conference, Paris, France. Introduction to Quality Gates. Generating Business Value through Information Systems.
bioassist.com
BioAssist Consulting Services
http://www.bioassist.com/resources.php
FDA's Compliance Program Guidance Manual for FDA Staff. FDA Compliance Policy and Regulatory Action Guidance. Regulatory Procedures manual for use by FDA Personnel. FDA's Guides to Inspections (for FDA investigators). Inspectors Technical Guides (older guidance documents.). Investigations Operations Manual (IOM) for FDA Investigators. FD-483s Frequently requested from FDA through Freedom of Information. Warning Letters on FDA's Website. Enforcement Reports (recalls, seizures, etc.).
hammondctc.com
Links - Hammond Clinical Trial Consulting, LLC
http://www.hammondctc.com/8.html
Hammond Clinical Trial Consulting - consulting at just the right level. Clinical and Regulatory Services. Data Mgmt and Biostatistics. The University of Washington Master's in Biomedical Regulatory Affairs. This is a link to the Master's degree in Biomedical Regulatory Affairs offered by the University of Washington. The Organization of Regulatory and Clinical Affairs. Public Profile for David Hammond on LinkedIn. Hammond Clinical Trial Consulting, LLC.
amwanw.org
Resources - American Medical Writers AssociationAmerican Medical Writers Association
http://www.amwanw.org/resources
Other Professional Associations and Organizations. Accreditation Council for Continuing Medical Education (ACCME). On LinkedIn Group Facebook. Alliance for Continuing Education in the Health Professions (ACEHP). American Association for the Advancement of Science (AAAS). American Medical Writers Association (AMWA). American Medical Writers Northwest Chapter (AMWA-NW) on LinkedIn Group. Association for Women in Communications (AWC). University of Washington Chapter. Association of Women in Science (AWIS).
bnasearch.com
HEOR, Market Access, Regulatory Biostatistics: BNA Search Resources | BNA Search
http://bnasearch.com/resources
HEOR & Market Access. 8211; Health Economics. 8211; International Society For Pharmacoeconomics and Outcomes Research. 8211; International Health Economic Association. 8211; Regulatory Affairs Professional Society. 8211; Bay Area Clinical / Regulatory Roundtable. 8211; Organization of Regulatory and Clinical Associates. 8211; American Statistical Association. 8211; International Society for Clinical Biostatistics. 8211; International Biometric Society. 8211; Society for Clinical Data Management.
tmquality.net
TM Quality Consultants, LLC | Quality Assurance And Compliance Links | Seattle, WA
http://www.tmquality.net/resources.html
TM Quality Consultants, LLC. Quality Assurance And Compliance Links. US Food and Drug Administration Home Page. The European Commission -Enterprise and Industry Sectors Page. The Organization of Regulatory and Clinical Associates Online - Northwest Chapter - ORCA. American Society for Quality - ASQ. Regulatory Affairs Professionals Society - RAPS. The Society of Quality Assurance.