David Buckley & Associates Pty Ltd – GMP Consultants – “Navigate GMP with DBA” © 4/2002

 

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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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Recent News
How to Access Australasian legislation, where to find Australasian Law including Acts and Regulations



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
  1. Assign the task an Item Type of "Validation"
  2. Assign Action Interval of 365 days (or 180 days for 6 monthly revalidation)
  3. Reference the validation protocol number (minus revision number) in the procedure field
  4. Place a link to each revision of the validation protocol in the links grid in the 'Form View"
  5. 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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