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Happy to recommend my friends and colleagues
 ”Natural Health Matters” Val
Johanson’s website – Regulatory affairs, including natural
health products.
“Advantage Medical Products
Consulting Pty Ltd” Bren Milsom’s website, GMP and regulatory affairs for
drugs and devices
Computer Systems
We are pleased to be a Rockwell
Automation Contractor for GMP assessments of computer systems. We can
provide a gap analysis and remediation plan in association with RA, for
all your process automation needs, to meet 21 CFR part 11, cGMP Annex 11,
or HACCP.
Ask for details!
Links
Links to help you navigate to regulatory
and quality information sources
(report
new or bad links please to info (at) navigategmp.com – thanks)
(links checked 17 Nov 2004)
Useful links
Australian
legislation
AAMI ISO
CDER Homepage
CDRH Homepage
Center for Disease
Control & Prevention
European Medicines
Evaluation Agency
FDA GMP Regulations
FDA Homepage
EU GMP Guide Vol 4
FDA Warning
Letters FDA
Federal
Food, Drug & Cosmetic Act
US Import
Alerts
International Conference on
Harmonisation
Int. Society for
Pharmaceutical Engineering
ISO
online
JP
(Japanese
Pharmacopoeia) online
EU Code of GMP (Eudralex Vol 4)
OECD GLP Regulations
Parenteral Drug Association
Pharmaceutical
Inspection Convention/Scheme
TGA
US or European Pharmacopoeia
WHO GMP training modules
World Health Organization
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