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Regulatory and Governing Agencies (USA and other countries)

FDA Related Sites & Clinical

www.fda.gov

www.fda.gov/cdrh - center for devices and radiological health

www.fda.gov/cber/recalls.htm

www.fda.gov/foi/warning.htm

www.ncls.org - National Committee for Clinical Laboratory Standards

Professional Organizations

Institute of Environmental Sciences & Technology (IES now: IEST)
American Society for Quality (ASQ)
American Society for Testing and Materials (ASTM)
American Chemical Society (ACS)
National Institute of Standards and Technology (NIST)
International Society of Pharmaceutical Engineers (ISPE)
Joint Equipment Transition Team (JETT)
Global Engineering Documents
American Society for Microbiology (ASM)
Medical Lab Observer (free publication)
College of American Pathologists (CAP)
International Assoc. for Pharm. Science & Technology (PDA)
Platform for Medical Device Industry (Devicelink)
Association Of Analytical Communities (AOAC)
Statisticians in the Pharmaceutical Industry (PSI)
Orange County Regualtory Affairs (OCRA - South Cali - RA group)
 

 

Quality/ISO,QS-9000/Reliability/Benchmarking

Quality Engineering / Validation Services - my other site

ISO 9001 Compliance- provides companies with the easiest-to-use standard operating procedures and forms package available. We also provide documents for CE marking quality compliance and a quality manual with corresponding SOP's and forms.
Adams Six Sigma - Specialist in total quality management, strategic planning, goal setting, team building, employee motivation, and statistical process control.
BPIC - Practical help with manufacturing planning and control (ERP, MRPII, JIT, TQ, CIM etc.) - case studies, courses, checklists, consulting, jargon buster, top software links and an excellent book.
Six Sigma Systems - provides total solutions of six sigma, statistical process control, total quality management, lean manufacturing for constant process improvement through innovative problem solving techniques.
Exalt Management is a Houston engineering, technical and technical sales search firm specializing in national and multinational professional job searches with a unique approach to selecting the best senior and middle management professionals for the job. Our Houston firm provides a range of services to meet the specific needs of each individual client.
Resource site for everything to do with ISO 9000. Full of newsletters, articles, links and other resources - ALL FREE - in one easy to navigate site to save time and money.
SixSigmaZone.com - Timely, Topical, Fresh, Credible, Clear and Concisely
Worded Information for the Six Sigma and Process Improvement Community.
 

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