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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.
Be advised that the copyright for the phrase 'Navigate GMP
With DBA' and the sextant symbol, including the sextant symbol overlaid
or underlaid with stars including but not limited to the stars of the
Southern Cross, was copyrighted by David Richard Mull Buckley in April
2002, and assigned to David Buckley And Associates Pty Ltd, a fully
incorporated company in Australia registered with the Australian
Securities And Investment Commission (ASIC) with the registered Australian
Business Number (ABN) 69 103 221 129.
'DBA' is a common trading name for many, many, many
businesses (some of whom claim trademark registration on the 3 letters D,
B, and A, in that order) and we, the Directors of David Buckley And
Associates Pty Ltd in no way, shape or form have anything whatsoever to do
with, or endorse, support, use, recommend, agree something is good,
accept, acclaim, admire, applaud, appreciate, approbate, be big on,
commend, countenance, esteem, favour (alternatively favour), go along
with, like, love, praise, regard highly (or any regard at all for that
matter), respect, string along with, take up on, think highly of (or think
of at all for that matter) support, authorize, accredit, advocate, affirm,
approve, attest, authenticate, back, back up, bless, boost, certify,
champion, commend, confirm, countenance, defend, favour (alternatively
favour), give a boost to, give green light, give our word to, go along
with, go in to bat for, guarantee, lend our name to, okay, praise, push,
ratify, recommend, rubber-stamp, sanction, second, stand behind, stand up
for, stump for, subscribe to, sustain, underwrite, uphold, vouch for,
warrant, witness, endorse (alternatively indorse), patronize, plink (for)
plump (for) plunk (for) or plonk (for), embrace, espouse; abet, aid,
assist, help, work with with, employ, or are employed by, contract work
with or for, or second (with), side (with), bolster, boost, advance,
forward, further, plug, talk up, or bail up or out any of the entities
below. Alternatively neither do we want to foil, frustrate, interfere,
oppose, sabotage, thwart, disagree, disapprove, censure, oppose, protest,
reject, repel, condemn, censure, chastise, criticize, damn, decry,
denounce, deplore, deprecate, detract, discommend, disesteem, disfavor,
dislike, dismiss, dispraise, expostulate, find fault with, find
unacceptable, frown on, look askance at, look down on, object to, oppose,
reject, remonstrate, reprove, slam, spurn, take dim view of, take
exception to, turn down, or veto, clash, contradict, counter,
disharmonize, dissent, diverge, run counter to, or be affiliated with now
or in the past and heaven and god willing, the future, with any services
or products or others things tangible or intangible produced by, or
invented by, or copyrighted by, or trademarked by, or registered by, nor
do we intermingle with, converse with, socialise with, banter with, or
otherwise engage in social intercourse with any the following entities (in
alphabetical order):
D Barber Associates, D Bello Associates, Daimler Benz Aerospace, Dairy
Business Association, Dandenong Baseball Association, Danish Badminton
Association, Danish Beekeepers Association, Danish Beekeepers' Association
(Danmarks Biavlerforening), Darwin Basketball Association, David Bailey
Associates, David Bartholomew Associates, David Begg Associates, David
Bell Associates, David Bellamy Associates, David Bergum Associates, David
Blackmore Associates, David Brown And Associates, David Buckley And
Associates (Plumbers), David Burnett Associates, David Butcher Associates,
Db Agriculture Dba (Powershares Db Agriculture), DBA Accountants, DBA
Lawyers, DBA Manufacturing, DBA Or The Dutch Barge Association, DBA
Property Solutions, De Belder Associates, Deaf Basketball Australia, Deaf
Bikers Of America, Debt Buyers Association, Decatur Business Association,
Deerfield Business Association, Dekalb Bar Association, Delaware Bankers
Association, Denton Baptist Association, Denver Bar Association, Denver
Business Associates, Department Of Biological And Agriculture, Department
Of Budget And Accounts, Department Of Business Assistance (Virginia, Usa),
Derby Business Administration, Derrick Barge Azerbaijan, Design Bda
Architecture, Design Business Association, Designed Blinds Australia,
Designer Boats Australiadetroit Batting Academy, Detroit Building
Authority, DBA Deutsche British Airways, Deutsche Bahn Aktiengesellschaft,
Deutsche Botschaft In Accra, Deutsches Biographisches Archiv, Development
Bank Associates, Dick Buss Associates, Differently-Abled Business
Association (Portland, Or), Digital Broadcasting Alliance, Digital
Broadcasting Australia, Dinkytown Business Association, Directory Of
British Associations, Disabled Businesspersons Association, Disc Brakes
Australia, District Bar Association, District Business Administrators,
Diversity Business Association, Dixie Business Alliance, Dobbin Bolgla
Associates, Dogwood Buckskin Association, Don Breazeale And Associates,
Don Buchwald And Associates, Doug Bean Associates, Dover Baptist
Association, Downeast Business Alliance, Downtown Berkeley Association
(Berkeley, Ca), Downtown Bloomington Association, Downtown Boise
Association, Downtown Bordentown Association, Downtown Business
Association, Drei Buchstaben Abkuerzungen, Duke Bar Association, Dunlap
Bumpas Associates, Dunn And Bradstreet, Dutch Business Association, and
NSF DBA or NSF-DBA
- in any country, territory, province, state, in any part of the world and
outer space (if ever there is a future entity located there), including
but not necessarily limited to the following:
Afghanistan, Akrotiri, Albania, Algeria, American Samoa, Andorra, Angola,
Anguilla, (the) Antarctica, Antigua And Barbuda, Argentina, Armenia, (the
Artic), Aruba, Ashmore And Cartier Islands, Australia, Austria,
Azerbaijan, Bahamas, The Bahrain, Bangladesh, Barbados, Bassas Da India,
Belarus, Belgium, Belize, Benin, Bermuda, Bhutan, Bolivia, Bosnia And
Herzegovina, Botswana, Bouvet Island, Brazil, British Indian Ocean
Territory, British Virgin Islands, Brunei, Bulgaria Burkina Faso, Burma
(alternatively Myanmar), Burundi, Cambodia, Cameroon, Canada, Cape Verde,
Cayman Islands, Central African Republic Chad, Chile, China Christmas
Island, Clipperton Island, Cocos (Keeling) Islands, Colombia, Comoros,
Congo, Democratic Republic Of The Congo, Republic Of The Cook Islands,
Coral Sea Islands, Costa Rica, Cote D'ivoire, Croatia, Cuba, Cyprus, Czech
Republic, Denmark, Dhekelia, Djibouti, Dominica, Dominican Republic,
Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Estonia,
Ethiopia, Europa Island, Falkland Islands (alternatively Islas Malvinas),
Faroe Islands, Fiji, Finland, France, French Guiana, French Polynesia,
French Southern And Antarctic Lands, Gabon Gambia, The Gaza Strip, Georgia
Germany Ghana Gibraltar, Glorioso Islands, Greece Greenland Grenada
Guadeloupe Guam Guatemala Guernsey Guinea, Guinea-Bissau, Guyana, Haiti,
Heard Island And Mcdonald Islands, Holy See (alternatively <The Vatican
City), Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran.
Iraq, Ireland (alternatively Eire), Isle Of Man, Israel, Italy, Jamaica,
Jan Mayen. Japan Jersey Jordan, Juan De Nova Island, Kazakhstan Kenya
Kiribati, South Korea (Republic of Korea ROC), North Korea (Democratic
Republic of Korea DPRK), Northern Ireland, Kuwait, Kyrgyzstan, Laos,
Latvia, Lebanon, Lesotho, Liberia, Libya, Liechtenstein, Lithuania,
Luxembourg, Macau, Macedonia, Madagascar, Malawi, Malaysia, Maldives,
Mali, Malta, Marshall Islands. Martinique, Mauritania, Mauritius, Mayotte,
Mexico, Micronesia, Federated States Of Moldova, Monaco, Mongolia,
Montserrat, Morocco, Mozambique, Namibia, Nauru, Navassa Island, Nepal,
Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua
Niger, Nigeria, Niue, Norfolk, Island, Northern Mariana Islands, Norway,
Oman, Pakistan, Palau, Panama, Papua New Guinea, Paracel Islands,
Paraguay, Peru, Philippines, Pitcairn Islands, Poland Portugal, Puerto
Rico, Qatar, Reunion, Romania, Russia, Rwanda, Saint Helena, Saint Kitts
And Nevis, Saint Lucia, Saint Pierre And Miquelon, Saint Vincent And The
Grenadines, Samoa, San Marino, Sao Tome And Principe, Saudi Arabia,
Scotland, Senegal, Serbia And Montenegro, Seychelles, Sierra Leone,
Singapore, Slovakia, Slovenia, Solomon Islands, Somalia, South Africa,
South Georgia And The South Sandwich Islands, Spain, Spratly Islands, Sri
Lanka, Sudan, Suriname, Svalbard, Swaziland, Sweden, Switzerland, Syria,
Taiwan, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tokelau, Tonga,
Trinidad And Tobago, Tromelin Island, Tunisia, Turkey, Turkmenistan, Turks
And Caicos Islands, Tuvalu, Uganda, Ukraine, United Arab Emirates, United
Kingdom (alternatively <the UK), United States of America (alternatively
<the USA), Uruguay, Uzbekistan, Vanuatu, Venezuela, Vietnam, Virgin
Islands, Wake Island, Wales, Wallis And Futuna, West Bank, Western Sahara,
Yemen, Zambia and Zimbabwe.
*If you have come to this website by accident and are looking for one of
the above entities, or any other ˇ°DBAˇ± other than the trading name of
David Buckley and Associates Pty Ltd, then please immediately, now,
forthwith and instantly navigate away from this website, at once. *
*NOW please read on!*
*I agree that by entering the site I have read and understood the above *
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 May 2012
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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
-
Assign
the task an Item Type of "Validation"
-
Assign
Action Interval of 365 days (or 180 days for 6 monthly revalidation)
-
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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