Dr. rer. nat. Ralf D. Hess, MSc.,  PhD

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