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Free
downloads – free PDFs to download
But first read the fine print below!
ü Aseptic filling
validation checklist (pdf)
ü Barr
Laboratories v US FDA (OOS precedent) (pdf)
ü Barr Labs OOS Court case
interpretation (pdf)
ü Computer talk
(warning! Large file size) D Buckley (pdf)
ü DBA presentation (warning! Large file
size) (pdf)
ü Dry
heat sterilisaton validation checklist (pdf)
ü Due Diligence article D Buckley (pdf)
ü Freedom
of Information FOI article by D Buckley (pdf)
ü Internal
audit checklist – PIC/S and 21 CFR 210-211 (New Sep 2006)
ü Printed label leaflet printer checklist
(pdf)
ü Qualify your consultant ! (pdf)
ü Quality Improvement Form
(pdf)
ü Unannounced GMP
audits by Regulatory agencies
Regulators are likely to arrive unannounced – do you know what to
do? (Aug 2005) (pdf)
The David Buckley
& Associates’ (DBA) web site is provided to you free of charge,
"as is" without warranty of any kind, either expressed or
implied, including, but not limited to, the implied warranties of
merchantability, fitness for a particular purpose, or non-infringement.
in no event shall DBA be liable for any damages whatsoever, including
special, indirect, consequential or incidental damages or damages for
loss of profits, revenue, use, or data whether brought in contract or
tort, arising out of or connected with any DBA web site or the use,
reliance upon or performance of any material contained in or accessed from
any DBA web site.
All information in these
articles is intended for your general knowledge only and is not a
substitute for expert advice. Neither David Buckley & Associates Pty
Ltd nor any of their employees or associates, makes any warranty, express
or implied, including warranties of merchantability and fitness for a
particular purpose, or assumes any legal liability for the accuracy,
completeness, or usefulness of any information from this document. The
opinions expressed in the articles are those of the author. The article
is intended as a general discussion of legal and other issues concerning
due diligence. Advice given on issues is not legal advice or a legal
opinion. It is suggested all persons seek independent counsel to act upon
any laws discussed in any article.
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