GMP/ISO Activities

Drugs/Devices

GMP/CMC/QUALITY

 

  • GMP, FWP (2nd QP, registered with SWISS MEDIC, RHI, CH, Basel SEP 2007 to NOV 2012

  • GMP, External QA (vaccines manufacturer), Germany, UK, 2009-2011

  • GMP/CMC/QUALITY/Reg. Affairs, drug-device combination products (loaned executive), Switzerland 2011-2013

  • GMP, Medical Device, Directive 93/42/EC, ISO 13485, 21 CFR part 820, CAPA remediation, Switzerland, OCT- NOV 2012.

  • ISO 13485/ ISO 14971/ Dir 93/42/EC, 21 CFR part 820 device development, CE-marking, STED, 2013-2015

  • GMP, CMC/QUALITY Biosimilar mab development to first MA in EU (world), KOREA, 2007-2013

  • GMP, API (DS) & DP Batch Disposition experience (regular QP-TCs, trouble shooting), Germany, 2013

  • ISO 9001:2015, implementation (12/2016 - 3/2017), Germany

  • GLP, External QA (registered with CA) for GLP, ChemG §19a laboratory, (Germany), 2014-2015

  • 21 CFR 820.100, Medical Devices, CAPA (OCT  2017- MAR 2018)

  • ISO 13485:2016, ISO 14971:2012, IVDD/ preparation IVDR, implementation from 2/FEB 2018 - 2 FEB 2019, Germany 

 

AUDITS (1 or 2 days if not indicated otherwise, 2007 until today)

 

  • GLP/ISO 9001:2008, Laboratory, Germany, AUG 2007,1

  • GMP, AMG, packaging, labeling, Germany, OCT 2007,1

  • GMP, EU GMP PART II, Biologics AP) INDIA, JUN 2008 *

  • GMP, ICHQ5, vaccine substrate, Germany, SEP 2009,*

  • GMP, AMG, vaccines, Germany, DEC 2009,*

  • GMP, EU GMP Part I, solid dosage USA, FEB 2010,1

  • GMP, EU GMP Part I& II India, MAR 2010, (6 sites)*

  • GMP, EU GMP Part II, Biologics API, Austria, SEP 2009,1

  • GMP, AMG, packaging, labeling Germany, APR 2010,1

  • GMP, EU GMP Part I & II Sterile processing audit (multipurpose biologics/shared facility, manufacturer) under attorney witness), USA, OCT 2010 to DEC 2010*,1.

  • GLP, GCP, ISO 17025:2005, ISO 15189 Laboratory Denmark, 12 DEC 2010*

  • GMP, QC laboratory UK, 5 MAY 2011,*

  • GLP, ChemG §19a, Laboratory Germany, 12 JUN 2012*

  • GMP, EU GMP Part I, Mock PAI, Biologic API, USA, 21-23, Oct 2012 *

  • GMP, Medical Devices, Dir. 98/79/EC, ISO 13485), Israel, 2-4, DEC 2012, (),1

  • GMP, EU GMP Part I, DP), JUL, USA, AUG 2013 ()*

  • Medical Devices, Dir. 93/43/EC, ISO 13485, 21 CFR part 820, Inspect readiness  Germany, SEP 2013,1

  • GLP, ChemG §19a, Laboratory, Germany, OCT 2013*

  • GMP, Medical Devices, 21 CFR part 820.100 (CAPA), Switzerland, NOV 2013 *,1

  • GCP/GLP, EMA/INS/GCP.532137/2010, 21 CFR part 58, 21 CFR part 11, Netherlands, AUG 2014,*

  • GLP, ChemG §19a laborator), Germany, OCT 2014*

  • GMP, Medical Device, Dir. 93/42/EC, Design Control, ISO 13485, DD, France, NOV 2014,*

  • GCP/GLP, EMA/INS/GCP.532137/2010, ISO 13485), Germany, MAR 2015,*

  • GMP, EU GMP Part II, API, Spain, MAY 2015,*

  • GMP, EU GMP Part I, DP, France, JUN 2015,*

  • GMP, EU GMP Part II, ICH Q9, (cross)-contamination, Biologics API manufacturing) Korea, Jul 2015, *

  • GMC/ISO 9001:2008, QC Laboratory, Brazil, SEP 2015,*

  • GMP/ ISO 9001:2008, cell culture medium, Austria, NOV 2015,*

  • GCP/Observational Study, Data Integrity, Italy, NOV 2015,*

  • Carrier audit, GDP/ applicable GMP and ISO 9001, 1 day, GERMANY, FEB 25, 2016*

  • Drug Product Manufacturer, sterile powder (injectables), 1 day, EU GMP Part II/Annexes, GERMANY; May, 4. 2016*

  • Carrier audit, GDP/ applicable GMP and ISO 9001, 1 day, GERMANY, MAY, 12, 2016*

  • Broker/ GDP chapter 10, appl. GMP, 1 day, GERMANY, 28 SEP, 2016

  • Drug Product Manufacturer, sterile solution, sterile powder (injectables), SPAIN, EU GMP Part I/Annexes, 2 days, 6 and 7 JUL, 2016*

  • Drug Product Manufacturer (solid dosage), SPAIN, EU GMP Part I/Annexes, 1 day Oct 18, 2016*

  • Carrier audit, GDP/ applicable GMP and ISO 9001, 1 day, GERMANY, JAN 10, 2017*

  • Secondary packaging (GMP/GDP), Germany, 1 day, FEB 1, 2017*

  • Drug Product Manufacturer (solid dosage) (EU GMP Part I, Annexes) , 1day, Germany, MAR 14, 2017*

  • Drug Product Manufacturer (sterile Solutions), SPAIN, EU GMP Part I/Annexes, APR 16, 2017*

  • Drug Product Manufacturer (sterile Solutions), FRANCE, EU GMP Part I/Annexes, MAY 30, 2017*

  • Drug Substance Manufacturer, ITALY, EU GMP Part II/ ICHQ7, JUN 28, 2017*

  • (GMP/EU GMP Part I/Annexes) Drug Product (sterile powder), ITALY, OCT, 11, 2017*

  • 21 CFR part 820, medical devices, 483 remediation activities, CAPA 820.100, complaints, 803, 820.198; OCT-DEC 2017, (7 weeks)*

  • GLP/ OECD (Archive), FRANCE, JAN 11, 2018*

  • EU/GMP Part I/Annexes, sterile solution Drug Product, Germany, APR 10 /11, 2018 (1)

  • EU/GMP Part I/Annexes, sterile solution, Drug Product, Greece, JUL 7, 2018* 

  • GMP/EU GMP Part I/Annex 1, Drug products (sterile solutions), 4 OCT, 2018, Spain*

  • GMP/EU GMP Part I/Annex 1, Drug products (sterile solutions, powder), 30 OCT; 2018, Germany*

  • ISO 13485/ISO 14971, IVDD, production, 21 & 22, NOV 2018. Germany (2 sites) *

  • EU/GMP Part I/Annexes, aseptic manufacturing, Drug Products, 14 and 15 JAN 2019, Turkey*

  • EU/GMP/GLP, Part I/OECD, Laboratory, 24 JAN 2019, Germany*

  • EU/GMP Part I/ Annexes, sterile powder, Drug Products
    30 JAN 2019, France*

  • EU//GMP Part II/ICHQ7 API, 14 FEB, 2019, Germany*

  • EU/GMP Part I/Annexes, sterile solution, Drug Products, 29 MAY, 2019, Germany*

  • EUGMP Part I/Annexes, sterile solutions, 17 JUN 2019, AUT*

  • EU/GMP Part I/Annexes, sterile solutions, 18 JUN 2019, AUT*

  • ISO 13485/21 CFR part 820, 8 JUL 2019, USA*

  • ISO 13485:2016/9001:2015, 17 JUL 2019, Germany*

  • EU MDD/MDR, class I, 19-23 AUG, 2019, Germany*

  • GMP/EU GMP Part II/ICHQ7/ Annexes, DS stability, 11 SEP 2019, Germany*

  • GMP/EU GMP Part I/ ICHQ7 Annexes, DS Biologics, 17 OCT 2019, Germany*

  • GMP/ EU GMP Part II, Annexes, sterile solutions, 27 SEP, 2019, Spain*

  • GMP/ IMPD, EU GMP, Annexes 13, Dir 2003/94/EC, 29, OCT 2019, Germany*

  • ISO 9001/13485/ 21 CFR part 820, 6 DEC 2019, Germany*

1: = co-auditor; *: = lead role as SME or lead auditor.

Note: No details for ISO 13485 /ISO 14971/ISO 9001 (5x) and ISO 17025 (2x) audits 1999 to 2007 provided

 

ADDITIONAL QUALIFICATIONS

 

  • APIC Certified Auditor (EU-GMP Part II, ICH Q7 Biologics, eff. from June 2014), License No.: 907

  • IRCA certified ISO 13485 Lead Auditor, (eff. from Jan 2015), License No.: 8897

  • TÜV North certified Safety Officer Medical Devices acc. to MPG §30 (2001)

  • Competent Authority certified Biologics Safety Officer acc. to Gen TG §15 (1992).

  • External QM for ISO 17025 laboratory (2003-2007)

  • ISO 13485 implementation, device manufacturer 2003

  • Lecturer and Course leader (Module 7) at EUCRAF (Post Graduate Master Course, European Centre for Regulatory Affairs Freiburg, University Freiburg/Germany/Strasbourg/France) on GxP (GMP, GLP, GDP with regards to MAA in the EU) compliance and the roles of the supervising authorities in the EU; (mentoring Master Thesis), 2011-2015

  • PDA Committee Member mAb since Dec 2014 (from 8th Workshop on Monoclonal Antibodies, SEP 2015) until SEP 2017 (10th Workshop on Monoclonal Antibodies)

  • QP Association, (Qualified Persons in Europe), member since 2007, No.:168681

  • CDx development  (Ligand-based assay) US and EU, approval, 2013

  • CE marking of devices, 510(k) , de novo 510(k), PMA Support (1998 - 2015)

  • Device Design Control (21 CFR 820.30) and  CAPA 21 CFR  820.100 (2010 -2015)

  • Med Dev Training for Experts and Auditors, NB QSZ, CH, OCT, 22-24,  2017

  • Visiting Lecturer: Quality for Pharmaceuticals, University of Freiburg, Faculty Pharmacy, Germany from OCT 15, 2018

  • Visiting Lecturer: Quality and Regulatory Affairs, Drugs and Devices (EMA), University of Applied Sciences Offenburg, Germany from NOV 6, 2018

  • Designated ISO 13485 auditor, Notified Body, Switzerland from 2019

  • Applicant Dakks auditor, ISO 15189 Virological Laboratories, from 2019

EDUCATION

Oct 1982 - Jul 1988

University of Freiburg/Germany

University Studies of Biology / MSc / Diplom-Biologe Univ. (Cell Biology, Microbiology, Genetics, Organic Chemistry

July 1988 – June 1991

University of Freiburg/Germany

Prof. Dr. G. Brandner (Dept. of Virology), Prof. Dr. R. Hausmann (Faculty of Biology), Prof. Dr. H.-U. Weltzien (Max-Planck-Institute for Immunobiology, Freiburg) at

Department of Virology, Institute for Medical Microbiology and Hygiene, Freiburg, Germany at the Albert-Ludwigs-University

PhD Thesis: Synthetic peptides as artificial tumor specific antigens: Analysis and induction of cytotoxic T-lymphocytes against SV40 T-Antigen.

1991-1996 (1998)  UNIVERSITY POST DOC

University of Freiburg/Germany

  • Peptide-based vaccines, adjuvants and Biological Response Modifyers (BRM), 1991 – 1993.

  • Experimental oncology, cell cycle and p53-dependent apoptosis and signal transduction of tumor suppressor protein p53, 1993 - 1996.

  • Medical Virology and Epidemiology 1986 - 1996.

  • Part time lecturer, holding courses and holding examinations in “Medical Microbiology”  (1988-1996).

  •  Responsible for signing off virological diagnostic reports, day and weekend services as “physician”/virologist on duty 1995 – 1996.

  • Mentoring MD- and PhD- and MSc- students (thesis) 1991- 1996;

  • Deputy head of laboratory

  • Biologics Safety Officer (GenTG, S2).

  • 1996-1998,  Post Doc, Visiting Scientist

RESEARCH INTERESTS

  • >10 years of experience in R&D, virology, vaccines development and experimental oncology (p53), medical virology and medical microbiology, medical microbiology courses assistance and holding examinations (8 years), “physician” on duty, signing off virological diagnostic reports (Dept. Virology, University Freiburg, 2 years)

  • Epidemiology of viruses and emerging viruses, biosafey of biologics

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