Curriculum-Vitae
Personal Information
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Ronald Plock
Contact data plock consulting
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Personal Skills / Qualifications / Services
| qualification | since | reference | qualifiaction in detail |
level |
| International Experience | CDmdd: EU, Switzerland FDA: USA, Japan (PMDA, STED) Others: China, Kuwait |
Expert Normal Normal |
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| Business Consulting | Business Development Startup Coaching for Medical- and Pharmaceutical Companies - business plans - budgets, financing, cash flow - ip strategy - project planning and controlling - public funding strategy |
Expert Expert |
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| Quality Management | ISO 9001 ISO 13485 Quality System Development and Maintenance Auditing (Internal and Supplier Audits) GAP Analysis |
Normal Expert Expert Expert Expert |
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| Regulatory Affairs | Medical Device Compliance Management Medical Directives 93/42/EEC, 2007/47/EC US FDA QSR 820, (21CFR part 11, 820, 210cGMP, 211) Combined Products (e.g. Drug Delivery Devices) Regulatory support (idea through design and registration to commercialisation) Normative standard specialist, Verification Specialist, CEmdd - (over 17 years experience in CEmdd regulated companies) FDA with external partners in Switzerland and USA - (over 11 years experience in FDA regulated companies) Auditor Experience in ISO 13485 and ISO 9001, Audit monitoring - (CB audits, internal and external audits) |
Normal |
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| Project Management | Project Management as Lead Project Manager, Project Manager and Part Project Manager, External Project Manager for Outsourcing Projects Project Plans Project Process Design and Execution / Project Controlling Team Leadership up to 40 team members (employees + consultants) |
Expert Expert Expert Expert |
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| Risk Management | Product Risk Management (ISO 14971) Company Risk Management |
Expert Normal |
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| Interim Management | Interim Management as - project manager verification & validation - quality manager, safety engineer - product manager |
Expert | ||
| Medical Technology |
Product Risk Management (ISO 14971) |
Expert |
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| Pharma | Regulatory Affairs Combined Products (medical product + drug product) Verification Combined Products (medical product + drug product) CAPA management in QA API department (drug substance) - Systemic and SAP related Deviations, Corrective Actions, Preventive Actions - Deviation/CAPA management and processing of deviations and CAPAs (specialized in systemically and reoccurring, process-relevant CAPAs, e.g. SAP related CAPAs) - Leading, executing and consulting in/of investigations - Leading, executing and moderating of expert meetings - GMP conform documentation in paper or / and SAP - Creating, reviewing, verifying of Excel based data base - Deviation and CAPA reporting, backlog reporting to Global Quality - Organisation and lead of the CAPA Phase 2 Backlog Teams - Planning and lead of Jour Fixes - Presentation of important topics/facts in different company boards FDA Inspection Readiness Internal Audits Creating and review of SOPs Creating of innovative SOP-MAPs for implementation in company intranet BPE (Business Process Excellence) Consulting in innovative SOP systems Process management |
Expert
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| Research & Development | Dipl.-Ing. Electronics (diploma TU-Berlin), Various Projects specialized in - PC based Measurement Systems, - LabView, Analog Electronics, Test Place Design, - Transducer Development Development of various kind of medical equipments (ME), ME authorisation & placing on the market - Class I, Class Is, Class Ie products - Class IIa, Class IIb products - co-development of Class III products |
Expert | ||
| Verification & Validation | Project Manager Verification & Validationn - Verification / Validation Master Plans - Verification / Validation Plans - Development of Test Designs and PC based Measurement Places - Test Reports - Clinical Study Design and Execution - Verification / Validation Summary Reports - V-Model |
Expert | ||
| Process Management | ISO 13485 GMP Process Validation GAMP4 Software Validation GAMP 5 Lean-Six-Sigma |
Expert Normal Basic Basic Basic |
Employed Experiances
| date | company | department / position |
responsability / tasks / experiance |
| 2006 - dato | plock consulting | owner / CEO | - consulting - quality management - regulatory affairs - interims management - project management - medical technology - research & development - verification & validation *** for more details see www.plockconsulting.com |
| 2001 - 2006 | World of Medicine AG, Berlin |
- Marketing Manager Urodynamics - Project Manager, Marketing & Technology Urodynamics - Project Manger PU, ProductUnit / ProfitCenter Urodynamics - Product Manager Urodynamics - Project director (R&D) Urodynamics |
- Regulatory Approval Europe (e.g. MDD 93/42/ECC) - FDA approval (U.S.A.) - Risk Management - Clinical testing and validation - Complaint Management - Technical documentation - Instructions for Use (IFU) - Service Manuals - Process management - Marketing strategy - International sales - Product management - Project management (R&D) - Product and Service Training (int.) - Product Tests (EMC & Safety) EN 60601-1 & EN60601-1-2 - Specialist for Urology and Urodynamics |
| 1996 - 2001 | WIEST International GmbH, Berlin |
- Vice CEO - Quality Management Representative - Medical Device Safety Rep. - Export Manager (int. Sales) - Head of R&D - Original member |
- Business management - Quality Management Representative - Internal Auditor - International Sales - R&D management - Regulatory Affairs (CE and FDA) - Specialist for Urology and Urodynamics pumps & insuflators |
| 1995 - 1996 | F.M. Wiest Forschung & Entwicklung, Berlin |
R&D engineer for hardware & software | - development of complex, high precision measurement devices - pumps and insuflators |
| 1990 -1995 | Hahn-Meitner Institut GmbH, Berlin |
Internship, Student Assistant R&D and Service for nuclear & medical measurement devices |
- Seminar paper (grade 1) and diploma (grade 1) - High precision Linear Amplifier bw: 1GHz & Impulse expansion bw: 1GHz |
| 1989 | Lunenburg & Partner Mediaservice GmbH, Berlin |
Marketing & Sales Assistant | Marketing Assistant and Advertising Panel Scout |
| 1988 | Union Zeiss Werke GmbH, Berlin |
Internship | Accounting |
Academic Record
| date | college | subject | Diplomarbeit | Studienarbeit | degree |
| 1987 – 1995 | Technical University of Berlin |
Science of Electronics |
Entwicklung eines Linearverstärkers sehr hoher Stabilität und Zuverlässigkeit Note: 1.0 |
Rechnergestütze Entwicklung einer Schaltung zur schnellen Impulsdehnung Note: 1.0 |
Diploma |
Language Skills
| language | level |
| German | native |
| English | business fluent |
| Französisch | elementary |
References
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In case of interest you have to sign a non-disclosure-agreements (NDA) to get our reference list of my/our TOP 10 customers (minimum: manager level since 2006).
Please understand that I/we give out references to third parties due to non-disclosure agreements with my/our customers only in accordance with the respective management teams and contacts.