DAVID BUCKLEY & ASSOCIATES PTY LTD, Navigate GMP with DBA

 

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Happy to recommend my friends and colleagues

"C. Lim Consulting Pty Ltd"  Dr Chen Lim - GMP consulting services

"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

Dr Andre J van Zyl    http://www.vanzylgmpinternational.com/index.htm


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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