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Ralf D. Hess, PhD

Principal Management Consultant
ENTOURAGE GmbH

Ralf D Hess, MsC, PhD, Principal Management Consultant, Entourage GmbH
Trained virologist > 30 years working in regulated environment, > 25 ys QA and RA: Drugs: EU GMP/ FDA GMP; Devices: EU ISO 13485/ FDA 21 CFR part 820 (QSR) and drug-device combination products. 2nd QP with Swiss Medic, Basel, CH, recombinant protein drug substance compliance, product release (2007-2012); Former (2015-2017) PDA Mab workshop committee member (2015-2017). Contribution to 1st biosimilar MAb (Incheon, South Korea, from 2007 to EMA-approved 2013) CMC/ Quality, PD assays, MoA, ADA/Nab. ISO 15189/17025 and CLIA/ CAP QA and audits. ISO, GLP (OECD/ 21 CFR 58) & CGMP regulation/ guidelines (US & EU), 483 (FDA Warning Letter & consent decree) remediation, drugs & devices; GxP (US & EU) & ISO & 21 CFR 820 Auditor; IVD & MD: R&D, quality, regulatory, CE-marking, 510(k), CDx development & approval (US & EU); Quality/CMC/Biologics/mabs/ vaccines
Dug-Device combination products.GLP deputy Facility Manager 20017-2018, GLP compliance/ audits (from 2007 until now). CDx development (post IVD approval), clinical studies, EU, US, CE-marking, US until approval, de-novo 510(k), (510(k) (predicate device), IVD QA and RA & Tech Doc, CE-Marking, 510(k), de-novo 510(k), PMA support. QSR and ISO 13485 & ISO 14971; ISO 15189 and ISO 17025- implementation, maintenance, audits, ww
Auditing: South America, North America, Europe, Turkey, South Africa, Asia (China, India, South Korea), (2007 to today: +95 GxP/ISO audits) in GLP, GMP (EU/ US), NCE (sterile, solid and semi-solid dosage), Biologics (mabs, rec. proteins and vaccines), ISO 13485/15189/17025, Risk (14971/ ICHQ9). IRCA Int. cert. auditor, ISO 13485; APIC int. cert. auditor ICHQ7 / Biologics, (training on new EU-GMP Annex 1 (JUL 5 & 6 2023), +50 peer-reviewed publications.EUCRAF 2011-2015: Lecturer/ Course Leader: Postgraduate Master Program “Regulatory Affairs for Biopharmaceuticals. Visiting lecturer at Faculty Pharmacy/ Chemistry (University Freiburg), Devices QA/RA)) from 2018 ongoing.

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