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Rudolf Wagner

rudolf-wagner

Adressdaten

Rudolf Wagner
Albert-Haueisen-Ring 70
67071 Ludwigshafen am Rhein
Deutschland

Bitte nutzen Sie das Formular

+4962159815216
+4962154563379

Qualifikation

Sachverständiger für Medizintechnik sowie Medizinische Instrumente und Geräte
  • BDSF-Mitglied
09.08.2022
DGUSV, BDSF, VDI, RAPS, EU AI Working Group

Zertifizierter Auditor ISO9001:2015, ISO13485:2016, IFS

PRRC (Person Responsible Regulatory Compliance) gemäß Art. 15 EU MDR 2017/745 und 2017/746 (IVDR)

Authorized Representative EU

AI in Medizin und klinischem Kontext

Globaler Qualitäts und Regulatorisch Verantwortlicher für alle Klassen

IMDRF Technical File erstellt für alle Länder (132) inkl. Einreichung for Medical Devices und IVDs aller Klassen

Mitglied in AI Working Group EU

Forensischer Gutachter für mehrere Firmen

Globaler Qualitäts und Regulatorisch Verantwortlicher für alle Klassen

IMDRF Technical File erstellt für alle Länder (132) inkl. Einreichung for Medical Devices und IVDs aller Klassen

Mitglied in AI Working Group EU

Forensischer Gutachter für mehrere Firmen

Dipl. Ing. (FH) Biochemie

Zertifizierter Auditor ISO9001:2015, ISO13485:2016, IFS

PRRC (Person Responsible Regulatory Compliance) gemäß Art. 15 EU MDR 2017/745 und 2017/746 (IVDR)

Authorized Representative EU

Since June 2022                   ADHOCON UG (haftungsbeschränkt)

                                               Founder, Owner and Managing Director

 

Company provides global Medical Devie and Pharma consulting services, Regulatory Intelligence and support (EU Representative and EU Person Responsible)

Approved Expert and Expert Witness for Medical Devices of all classes (EU)

Offering additional services : Regulatory Due Dilligence for M&A, Regulatory Penetration Testing and Social Engineering training, Business Continuity Management according ISO22301, QA and RA Forensic analysis and QMS on demand (ISO9001 and ISO13485 for legal manufacturers and suppliers)

Adhoc Consulting via messenger services (WhatsApp, Signal, Wire, Facebook)

 

 

 

Since October 2021             HUMA Therapeutics Limited

                                               Global Director Quality and Regulatory Affairs

 

  • Heading Quality and Regulatory Department for HUMA, a Software as a Medical Device (SaMD) legal manufacturer of a Class IIb (EU MDR) and Class II (US FDA 21CFR) Medical device Software solution
  • Worldwide registration and submission of SaMD to place on the Market
  • ISO13485, ISO27001, CyberEssentials and CyberEssentials+ certification, HIPAA, GDPR and DSGVO Compliance, ISO/IEC62304, 62366, 82304 Compliance, ICH and GCP compliance built in in lean QMS (44 procedures) with limited amounts of forms and use of Jira and Conluence as part of the documentation landscape incl. CSV andd Part11 Compliance
  • DueDilligence for Regulatory and Quality aspects for M&A activities and partnerships (AstraZenica, Bayer)

 

 

November 2016 –                 Getinge Group

September 2021                   Senior Director Quality and Regulatory Compliance EMEA

                                              

  • Heading QRC Teams (6 direct reports on Director level and 42 indirect reports) in the 5 EMEA sales regions including Matrix certification ISO9001:2015 and ISO13485:2016, achieved in 2019. All sites have moved to one Quality Management system and are on one certificate now for 9001 and one for 13485.
  • Sponsor and Project Leader for EMEA EU MDR implementation, successfully prepared sales and service units under their economic operator obligation.
  • Responsible for the Overarching Quality Management Systems for all Sales Regions covering from end to end all country’s operations including Registration of products, Authority interaction (FDA, EMEA, BfArM, SFDA, NMPA (chinese FDA) and management, Field corrective actions (Recalls), Complaints, non-conformity and CAPA mangement, implementation of all local and global regulations
  • Implementation and execution of AAM – Active Authority Management with BfArM, ANSM and MHRA as well as Jordan MoH, where we trained technical file reviewers
  • Implemented fully validated (US FDA CFR part 11 compliant) robotic software automation for complaint handling
  • Sposnor for global 3rd party product project, successfully implemented governance structure with supplier management process
  • Introduction and Sponsor Quality and regulatory Lean Six Sigma projects – Lean Quality Management, Lean Sales Support (Q-Ticket System), Lean Country Registration
  • Internal and external mentor for young leaders

 

 

March 2014 -                         Director Merck KGaA, BU Merck Serono

October 2016                        Head of Quality Development

 

  • Heading Quality Assurance and QPs for the Clinical Development of all clinical trial phases
  • Successfully implemented a new independent Quality Management System with ICH Qx for pharmceutical development and Quality by Design for all development projects, which was proven by US FDA during a PAI with 0 Form483 deviations.
  • Implementing processes for and managing successful in time transfers from R&D to Development and from Development to commercial production and Site to site transfers
  • Responsible for the Quality Management System for Clinical Trial Supplies, Analytics, Formulation Development, Operations, Dossier and Project Management
  • Managing existing and new 3rd parties worldwide according international regulations and standards (FDA cGMP, EU GMP, ISO13485)
  • Management for fully outsourced projects
  • Member of VFA Circle of Develeopment QA Heads

 

 

December 2012 –                 External Manufacturing Quality Manager Health & Hygiene

February 2014                       Reckitt Benckiser Healthcare UK

 

  • Managing existing and new 3rd party manufacturers according international regulations and standards (FDA cGMP, EU GMP, ISO13485, ISO 22716, ISO 9001, EC Dir 93/42, EC Dir 1223 / 2009 and food supplementary) in Europe and partially asia (Japan, India, China).
  • All quality aspects are managed and controlled : Raw materials, quality control, quality systems, logistics, manufacturing, documentation, release process
  • Issuing with all 3rd parties technical agreements (Agreements on roles and responsibilities), Specifications, Manuals and support of commercial agreements
  • Management of adverse events and consumer complaints
  • Management of recalls and mock-recalls
  • Reviewing and approving of all 3rd party related documentation (Specifications, SOPs, policies, Change Controls and contracts)
  • Auditing critical 3rd parties and approving all 3rd party related audit reports including their suppliers
  • Managing external audits by authorities (MHRA, European country authorities and notified bodies) with no major or critical observation
  • Actively working with authorities and notified bodies

 

April 2011 –                           Head of Quality

November 2012                    Kukident GmbH Germany, Reckitt Benckiser PLC Group

 

  • Head of Quality, Leading Quality Control including active release, Quality Management of site as well as service providers, suppliers and 3rd party manufacturer
  • Expansion and Maintenance of GMP Standards and the certification oft he site according german Medizinproduktegesetz, ISO9001, ISO 13485, ISO 22716, BRC Standard
  • Control and Approval of quality standards and policies in accordance with external and internal legislation and regulations
  • Ongoing development and continous Improvement of all internal quality processes
  • Coordination and Approval of all quality relevant documentations within Reasearch and Development, Production, Logistics and Distribution and quality
  • Review and Approval of all Specifications within Research and Development projects and ongoing life cycle management of exisiting products
  • Support, Due Dilligence and post-market surveillance of new product developments
  • Responsibly leading of internal and external audits and inspections
  • Operational and disciplinary leading of 5 direct reports in Quality department
  • Transfer of european and global changes with regards rto quality to local site

 

Special projects accomplished :

  • Member of global project team for global quality management software TrackWise, responsible for parts oft he Validation (DQ, IQ, OQ, PQ) and transfer and implementation to local site including transfer of exisiting quality documentation on site.
  • Change Control Standards Management in Health & Personal Care
  • Successful first time Certification of Weinheim site according cosmetic guideline and ISO 22716
  • First time Qualification (DQ, lQ, OQ, PQ) and Validation of all equipments and methods (succesful implementation according Medical Device Directive)

 

 

June 2009 –                           Head of Manufacturing and Teamleader GMP Compliance

March 2011                           Group

Warner Chilcott Germany GmbH (before Oct. 2009 Procter & Gamble Pharmaceuticals)

 

  • Headed the manufacturing (according cGMP FDA Regulation and German AMWHV)
  • Managing manufacturing of prescrition drug “Asacol”
  • Approving all commercial and clinical trial batches
  • Reviewing and approving of all manufacturing GMP documents, all qualification (DQ/IQ/OQ/PQ), validation documents as well as all Change Control procedures
  • Responsible for reviewing and approving validation and qualification documentation
  • Member of Supply Chain Team
  • Member of Quality Pillar (Total Productive Management System)
  • System Owner Deviation Management
  • Preparation and lead of authority audits in production area, Self Improvement Audits and internal audits (according german law AMWHV and AMG, cGMP / FDA and EMEA)
  • Preparation, review and optimisation of various key performance indeces as well as preparation and follow up of gap analysis and action plans

 

Teamleader GMP Compliance

  • Head of team batch record review (electronic based and paper-based batch record)
  • System Ownership of Trainings-System.
  • Integrated planning of process- und project-related actions regarding GMP and Compliance aspects (mainly validation, qualification, manufacturing instructions, regulatory support)
  • Key interface between production and quality systems, quality assurance, quality control, planning and warehouse and distribution

 

 

 

August 2005  –                      Lab scientist at Pharmaceutical Development Parenterals May 2009                        Abbott GmbH & Co. KG

 

  • CMC-responsible manager for biological drug substances in preformulation and formulation during all clinical phases, mainly phase I and II
  • Process development and process optimization, particularly of freeze-drying cycles
  • Production of clinical suppliy batchers in the pilot plant under aseptic GMP conditions (class A and Isolator)
  • Pharmaceutical analytics of different methods e.g. NIR, DSC, mDSC, Microscopy, Z-potential, stirring stability of proteins, viscosity, density, quantification and filtration tests
  • Responsible project manager for the rebuilding of a parenteral lab as well as acquisition of a new customized pilot-scale freeze-dryer
  • Member of the Communication Committee

Firmendaten

Adhocon UG (haftungsbeschränkt)
Albert-Haueisen-Ring 70
67071 Ludwigshafen am Rhein
Deutschland

Bitte nutzen Sie das Formular

+4962159815216

Firmendetails

Adhoc Consulting via Messenger

We support you anytime via your Messenger of choice

  • Quality and Regulatory consulting with AI powered Database of all 252 territories and its regulation worldwide

  • Adhoc documented Root Cause Analysis via VideoChat

  • Adhoc Meeting & Audit companion (we listen and chat with you)

  • CAPA, RCA, Deviation, Complaint and SAE / Vigilance reportability Check

Adhoc online services

With our 15 year ADHOCONTM Database sourced from over 150 Audits (as Auditor and Auditee) we are able to provide you the best practices and experience out of many company, Notified Body, Authority and Industry interactions.

QA & Regulatory QMS Penetration Testing Appraisal & Assessment
PRRC (MedDev) QMS on Demand (cGMP, ISO13485 & 9001) Regulatory Pentesting M&A Due Dilligence (Regulatory)
Auth. Rep. EU (AR, MedDev) Business Continuity Mgmt. ISO22301 Social Engineering Training Approved Expert MedDev
EU MDR, EUDRALEX, US, MDSAP preparation CAPA, Deviation, Complaint Backlog reduction Authority Communication Expert Appraisal and Assessment
Worldwide MedDev Registration Lean 6S QMS Improvement Mock up Recall QA & RA Forensics
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