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About
DAVID BUCKLEY & ASSOCIATES PTY LTD
40+ years
experience in therapeutic products GMP and quality systems:
pharmaceuticals, vaccines, blood, medical devices, medical gases!
We are an Australian company operating worldwide that conducts
professional GMP consulting for the pharmaceuticals, vaccines,
biologicals, medical gases, blood and blood products and medical devices
industries. We know GMP Consultants and GMP consulting!
We provide global consultancy and training on quality
systems in general and Good Manufacturing Practice, Good Laboratory
Practice, Good Distribution Practices (all “GXP”) for
pharmaceutical products, biological products (including blood collection
and processing, and vaccines), quality systems for medical devices,
active pharmaceutical ingredients and quality control laboratories.
Our main area of expertise is in the provision of services,
both locally and internationally, to a diverse range of small and large
clients in the pharmaceutical products and allied fields who are subject
to regulatory auditing. Our skills and experience can assist your company
in meeting its regulatory responsibilities and quality improvement
objectives. We can also help you prepare a comprehensive response to
adverse findings made during regulatory audits. And we have a wide range
of training programs – either tailored for in-house needs, or for
presentation at public seminars.
Write or email
David Buckley & Associates Pty Ltd
(ABN 6910 3221 129)
7 Catani Place,
Monash, ACT 2904, AUSTRALIA
Phone/fax: ISD
+ 61 2 6291 4626
E-mail:
david.buckley@navigategmp.com
Updated June 2011
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Recent News
How to Access Australasian legislation,
where to find Australasian Law including Acts and Regulations
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Trackpro" is a great calibration and maintenance tracking and
scheduling software package at
http://www.trackpro.org/.
It's compliant with 21CFR11 and PIC/S cGMP Annex 11 (aka Eudralex Vol
4 Annex 11) eg has audit trail, 3 levels of password protected
security, etc. A big plus: it's free for small companies (up to 150
items) and very very affordable for larger ones.
Will also track validation effort - for
example for a benchtop autoclave
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Assign
the task an Item Type of "Validation"
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Assign
Action Interval of 365 days (or 180 days for 6 monthly revalidation)
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Reference the validation protocol number (minus revision number) in
the procedure field
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Place a
link to each revision of the validation protocol in the links grid
in the 'Form View"
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Place
links to each approved validation report in the links grid in the
'Form View"
Other features - newsletter, user forum,
and very approachable author/owner - Al Weisenborn who answers the
info@ email queries within hours"
CONTACT US FOR INFORMATION ON THE
FOLLOWING COMPANIES:
Quintessence Enterprises Ltd, Kennedy
Business Centre, 12-14 Kennedy Avenue 1087- Nicosia, Cyprus website:
www.quintessence.com.cy GMP Seminars
Bionet-Asia Co Ltd
http://bionet-asia.com Thailand Vaccine manufacturers in emerging
countries, Vaccine distributors
Bio
Farma (Bandung, Indonesia) WHO
prequalification for vaccines
See www.biofarma.co.id
SMB
Validation
for computer validation in North
America contact a namesake David Buckley at www.smbvalidation.com
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