Personalities
| Name |
Burckhardt, Johann Jakob DVM, FVH, FAMH |
| Date of birth | June 07, 1945 in Zurich |
| Citizenship | Swiss |
| Marital Status | married |
| Children | two |
Education & Training
| 1974 | University of Zurich, Faculty of Veterinary Medicine, Doctoral Thesis, DVM |
| 1970 | Final Federal Exam and diploma |
| 1964 - 1970 | University of Zurich, Faculty of Veterinary Medicine |
Recent Mandates
| 2007 - 2009 | RRC power solutions, GmbH, Homburg/Saar, Germany: Quality Management System certification for medical devices/products (ISO 13485) |
| 2006 - 2007 | Roche Diagnostics GmbH, Mannheim, Germany: Diabetes Care – Compliance & Internal Audits |
| 2004 - 2006 | Roche Diagnostics GmbH, Mannheim, Germany: Near Patient Testing – Project support, esp. validation (process & methods) and qualification |
| 2003 - 2004 | Disetronic Medical Systems AG, Burgdorf, Switzerland: Project leader “Process validation & FDA-Documentation (Warning Letter)” |
| 2002 - 2003 | Roche Diagnostics GmbH, Graz, Austria: Project leader “Process validation new site” |
Start-up
| 2002 | Burckhardt Healthcare Consulting AG |
| 2000 | Burckhardt Healthcare Consulting |
Activities
| 1987 -2000 | Red Cross
Foundation “ZLB Central Laboratory Blood Transfusion Service SRC” 1996 Senior Vice President 1994 Head Blood Transfusion Service ZLB (incl. cGMP-responsibility under FDA licence for the New York Blood Centre) 1993 Vice President 1988 Head Department Laboratory Services and blood donation screening, Member of the Board ZLB |
| 1981 - 1987 | F. Hoffmann-La
Roche & Co. Ltd. Diagnostica, Basel, Switzerland, Research & Development 1984 Proxy holder “ppa.” 1982 Head “Immunology” 1981 Head “Hepatitis Group” |
| 1973 - 1980 | University of
Zurich, Medical Faculty, Dental Institute: Department for Oral Microbiology
and General Immunology (Prof. B. Guggenheim) 1975 Senior Lecturer 1973 Postdoctoral position |
| 1971 - 1973 | University of Zurich, Faculty of Veterinary Medicine, Institute for Pharmacology & Biochemistry: Thesis work in the Laboratory for Immunology (PD R.von Fellenberg) |
Certification
| 2001 | SAQ: Quality Management Course A 3.3-74 “Quality-Audits” |
| 1990 | FAMH-Certificate as Specialist in Laboratory Medicine, esp. Clinical Immunology (2001 Addendum: “incl. DNA/RNA Technologies”) |
| 1990 | Degree „FVH“ for Laboratory Medicine and Basic Research, Discipline „Basic Research“ |
Functions on behalf of the Swiss Federal Office of Public Health
| 1988 | Head National Reference Centre for Transfusion Transmitted Infections |
| 1988 | Head Confirmatory Laboratory for HIV-Serology |
Additional Experiences
| 1997 & 1999 | Pass FDA inspections without citing on Form 483 (Blood Transfusion Service ZLB) |
| 1999 | Implement Hepatitis C-Virus PCR screening for blood donations in Blood Transfusion Service ZLB, acquire third party Regional Blood Transfusion Services totalling about 2/3 of all blood donations in Switzerland |
| 1996 | Implement Internal Quality Standards for infectious disease screening in Blood Transfusion Service Swiss Red Cross |
| 1992 - 1995 | Head AIS-Project: ex
vivo-expansion of CD8-Tcells for therapy; plan, build, and validate a laboratory for cell culture for human use; approved by Swiss authorities for clinical trials |
| 1990 | Implement Anti-HCV-screening in
Switzerland (BTS SRC, by August 1), implement centralized confirmation procedure in Bern (ZLB) |
| 1988 - 2000 | Responsible Head for the
external proficiency scheme for the Blood Transfusion Service Swiss Red
Cross 1988 |
| 1988 | Successfully compete the training course in transfusion medicine (one week, organised by the German Association for Transfusion Medicine and Immunohaematology, DGTI), Bad Nauheim |
| 1985 | Launch of four Enzyme Immuno Assays: Roche Hepatitis B EIA-Line, including the first test containing recombinant HBcore Antigen on the world market |
| 1979 - 1980 | Visiting scientist (Swiss National Science Foundation): Cellular Immunobiology Unit, Tumour Institute, University of Alabama in Birmingham, AL, USA (Prof. Max D. Cooper, MD) - generate, select and grow hybridomas to produce monoclonal antibodies |
| 1973 - 1997 | Applied research in dental caries and periodontal disease using animal models in gnotobiotic rats |
Proffessional Affiliations
| American Association of Blood Banks, AABB | |
| American Society for Microbiology, ASM | |
| ISBT, and its Working Party for Transfusion Transmitted Diseases | |
| German Society for Transfusion Medicine and Immunohaematology (DGTI) | |
| FAMH (Swiss Association for Laboratory Services) | |
| Founding Member of SEVHEP | |
| Swiss Society for Haematology | |
| Swiss Society for Microbiology | |
| Swiss Society for Allergology and Immunology | |
| Swiss Society for Clinical Chemistry and Genetics | |
| Federal Expert Committee for AIDS, and its Subcommittee „Laboratory“ (til 2000) |