Curriculum Vitae: David Richard BUCKLEY (Rev a)

Transcription

1 A David Richard Buckley NZCS, BSc, MASM, FQSA David Buckley & Associates Pty Ltd ABN Catani Place, Monash, ACT 2904, david.buckley@navigategmp.com AUSTRALIA, Phone/fax Rev.: April 2015 Curriculum Vitae: David Richard BUCKLEY (Rev a) 1. Biodetails DOB 11 Feb 1947 Marital status Married, one daughter Father s name Bernard Battison Buckley (deceased) Mother s name Olive Phyllis Buckley (deceased) Wife s name Gillian Linda Buckley Daughter s name Anna Louise McNair Home Address 7 Catani Place, Monash, ACT 2904, Australia Postal Address PO Box 1931, Tuggeranong DC, ACT 2901, Australia Phone davidrbuckley@hotmail.com, david.buckley@navigategmp.com Website Citizenship Australian citizen Passport Australia E , issued Canberra 31 Oct 2011, expires 31 Oct 2021 APEC Asia Pacific Business Travel Card expires Sep Experience Summary More than 47 years experience in Pharmaceutical, Biological, and Medical Device Quality Systems. 20 years multinational industry experience Wyeth, Welcome, ICI 17 years Senior GMP auditor with the NSW DoH, NBSL and Australian Therapeutic Goods Administration (TGA), registered medical device and therapeutic goods and medicines lead auditor. 14 years GMP consultant. CEO David Buckley & Associates Pty Ltd Experience in pharmaceutical, vaccine, biological, blood and blood products, human tissue, radiopharmaceutical (PET and SPECT), and medical device manufacturing and regulation Audited, advised or conducted GMP training in 48 countries. Contract GMP expert for World Health Organisation, United Nations Children s Fund (UNICEF), United Nations Industry Development Organisation (UNIDO), United States Pharmacopoeia, US Aid, Medicines Sans Frontier (MSF, Doctors without Borders), Micro Nutrient Initiative, and other NGOs. Author of 17 WHO GMP training modules, conducted WHO GMP training for Industry, and GMP inspectorates in over 20 countries including the Sultanate of Oman, China, Australia, Cyprus, Nigeria, India, Bangladesh, Singapore, Malaysia, Indonesia, Ukraine, Nepal, Vietnam, Thailand, Myanmar, Iran, Cuba, Egypt, Denmark, USA, Costa Rica, and Germany. Biologicals auditing and manufacturing experience includes: o Blood and blood products, human tissue processing o Vaccines (recombinant, bacterial, viral, polysaccharide, live, attenuated and polyvalent) o Biologicals - Insulin and MCAb 3. US FDA experience and experience with 21 CFR 210, 211, and 11 Major clients include o Pfizer in North Carolina (Li-caps) and Pfizer Australia working with the client for compliance with 21 CFR 211 Navigate GMP with DBA page 1/5

2 o Becton Dickinson (Detroit) for vendor audit for Australia and New Zealand for supply into the USA of raw materials to meet 21 CFR o In co-operation with Asia Pacific Consulting (Melbourne) assisted in green field concept planning and realisation of factories in Australia, Bangladesh, and Indonesia for compliance with 21 CFR 211, 210, and 11 for export to the USA. o Worked with eg Alkem (Daman, India), and Galentic (navi Mumbai, India) for realisation of compliance with 21 CFR 211 for export to the USA. o Worked with about 10 other companies to assist compliance with global standards including compliance with US FDA 21 CFR 211 to allow ANDA to be progressed to marketing. Eg Gutis Pharmaceuticos (San Jose, Costa Rica - generics), and Haupt (Munich, Germany cytotoxics under sub-contract to Wyeth for export to the USA), and As a Senior GMP Inspector with TGA (Australia) worked with the US FDA on development of harmonised inspection approach including joint and observer inspections in USA, Puerto Rica, and Australia. Worked on committees to ensure harmonised approach USA/Australia, eg on 21 CFR 11 and Annex11 on computer validation, and electronic signatures. 4. Major current clients PT Bio Farma, Bandung, Indonesia vaccine, antisera, and biologicals manufacturer BioNet Asia, Thailand vaccine R&D and clinical trials. Asia Pacific Consulting group (Australia, Bangladesh and Indonesia) 5. Clients in previous 3 years Becton Dickinson (Detroit). Vendor audits in Australia/NZ Indonesian Badan POM, Thai FDA, Thai Red Cross, Queen Sirikit Memorial Institute CenBio (China), WHO(Vaccines Prequalification), Medicines Sans Frontiers (MSF-Paris) (prequalification of Essential Drugs), UNICEF (prequalification of UN essential drugs and medicines) Australian Atomic Energy Scientific Organisation (ANSTO) radiopharmaceuticals manufacturing and Cobolt60 gamma irradiation, PET cyclotron. Gutis Farmaceuticos, Costa Rica, Lion Nathan (NZ) 6. Highlights Missions for United nations agencies, including WHO, UNIDO and UNICEF Vietnam vaccines projects Nigeria yellow fever vaccine workshop Cuba, USA, Belgium vaccines prequalification Navigate GMP with DBA page 2/5

3 China, Bangladesh, Indonesia, Egypt, Bosnia, Nepal, Thailand (some in combination with PATH), Myanmar, Iran, Cyprus, North Korea, Oman, North Korea (DPRK) Vietnam vaccines GMP and capacity building, working with CENCOBI India many projects including vaccines GMP and capacity building, vaccines prequalification Pandemic Influenza preparedness projects Cyprus GMP Training on behalf of Quintessence for the Cypriot industry and Cypriot Ministry of Health Egypt Vacsera vaccines manufacturing World Bank Indonesia 2 month project working with the Indonesian Badan POM (National Agency for Drug and Food Control) project to develop the documented quality system for GMP inspection and certification to PIC/S and WHO standards 7. Qualifications and registrations Pharmaceutical Chemistry NZCS (Chemistry), Auckland New Zealand) BSc (Microbiology) (Otago, New Zealand) MASM (Professional Member of the Australian Society for Microbiology) FQSA Fellow of the Quality Society of Australasia (FQSA) Quality Management System Lead Auditor: International Register of Certificated 8. Experience with regulatory agencies years with NSW Dept Of Health, GMP auditor In February 1984 I joined the NSW Department of Health Pharmaceutical Services Section, when my supervisors were Barry Mewes, the NSW Chief Pharmacist, and Mr John Lumby, the NSW Deputy Chief Pharmacist. I worked at the level of Pharmacist 2 in the GMP inspection unit which regulated the NSW Cosmetic and Pharmaceutical Acts and regulations, and main duties were the inspection of premises licensed for manufacture of pharmaceuticals. I worked with other GMP auditors such as Bruce Graham, Barry Mewes, and John Martin. My namesake Dr David Buckley took my position when I left in 1988 to join the National Biological Standards Laboratory (NBSL, which became the TGA) of the Commonwealth Department of Health. During the period in service with NSW DoH I inspected approximately 100 companies ranging from 2-3 employees to multinationals such as Telectronics, Kolmar, Domedica, Cochlear, Reckitt and Colemans, Johnson and Johnsons, Sandoz, Pfizer, Parke Davis/Warner Lambert with greater than 100 and up to 700 employees years with NBSL/Therapeutic Goods Administration of Australia - Senior GMP Auditor. Editor of Codes of GMP In August 1988 I joined the NBSL section concerned with GMP inspections and GMP standards settings as a Senior GMP Auditor A major NBSL function in the period 1988 to 1990 was the revision of the Code of GMP. I served on the Code of GMP review committee (headed by Bruce Graham) which met regularly. I was the Code of GMP sub-editor and did all the desk top publishing that resulted in the final 1990 Code of GMP. During this period the revised Therapeutic Goods Act was developed which resulted in a uniform federal licensing system for all therapeutic goods manufacturing in Australia for corporations. Navigate GMP with DBA page 3/5

4 In 1990 I carried out the development in collaboration with the Blood Banking industry and was Editor and Principal Author of the Code of GMP for Blood and Blood Products and introduced a system of Australiawide licensing for human blood collection for production of plasma for further processing y CSL. In 1993 after Bruce Graham retired I took over as Editor of the Codes of GMP, and Secretary of the GMP subcommittee of the Therapeutic Goods Committee. During the time I was author of the various Manufacturing Principals which instrument gave effect to the Minister s requirements for GMP to be followed, and Editor and Principal Author of the Code of GMP for Sunscreens, Compressed Medical Gases, Good Distribution Practices, and Editor of the Code of GMP for Human tissues. A requirement of the Minster and the Therapeutic Goods Committee was that any proposed Code of GMP, or change in the Act or regulations be given as wide a consultation as possible before the change was agreed and implemented. A consensus view was to be obtained and a regulatory impact assessment made Consultancies and retainers David Buckley and Associates Pty Ltd now has signed a new retainer agreement with one major client PT Bio Farma (Indonesia) to provide 30 days training and GMP consulting on seasonal influenza and EPI vaccines in period 7-12/2007. The Associates who will conduct the work will be David Buckley FQSA (15 days GMP training only), and Dr Gordon Firth, BVSc, MSc (15 days veterinary services for SPF chickens, small and large animals, vaccine risk analysis and management, validation protocol development, QC laboratory proficiency verification). Major clients that provide more than 75% of current work UNICEF Copenhagen (prequalification of Essential Drugs) Médecins Sans Frontières (MSF-Paris) (prequalification of Essential Drugs, GMP training) Micronutrient Initiative of India (Vitamin A and other micronutrient projects) Other UN agencies (Eg UNIDO, UNFPA) and World Bank projects Projects in the last 10 years included o United States Pharmacopoeia (USP) training and consulting in Ukraine, and China o Consultant for last 11 years for PT BioFarma Indonesia, contract to provide GMP training consulting, and advice on WHO requirements for early childhood vaccines, including measles, polio, diphtheria, tetanus, pertussis, HIB, flu vaccine, etc o Gutis project in Costa Rica for building and commissioning a pharmaceutical factory to manufacture sterile and non-sterile pharmaceuticals, including highly potent and toxic, and sex hormones. o Bangladesh, India and China - 7 missions for UNICEF - assignment for qualification of pharmaceutical manufacturers and GMP training. o World Bank - Indonesia 2 month project working with the Indonesian Badan POM (National Agency for Drug and Food Control) project to develop the documented quality system for GMP inspection and certification to PIC/S and WHO standards. o WHO assignments in Belgium, Bosnia, China, Cuba, Cyprus, DPRK, Egypt, India, Indonesia, Iran, Japan, Nepal, Myanmar, Nigeria, Sultanate of Oman, Switzerland, Thailand, United States of America, Vietnam (various projects including audit of sterile and non-sterile pharmaceuticals and APIs, and vaccines manufacture and supply) o WHO committee member for revision of Codes of GMP relating to biologicals and vaccines. o PFSCM (and PEPFAR - The President of the United States Emergency Program for Africa), missions to India for evaluation of essential drugs. o Becton Dickinson supplier evaluation materials from food producing animals for use in pharmaceuticals, in Australia and New Zealand. o Contract auditor for Beckton Dickinson in New Zealand and Australia. o Worked with APC for design and commissioning pharmaceutical factories in Indonesia and Bangladesh Navigate GMP with DBA page 4/5

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