Detailed Curriculum Vitae
Personal Information
|
Ronald Plock
Contact data plock consulting
|
 |
Personal Skills / Qualifications / Services
| qualification | since | reference | qualifiaction in detail | level |
| International Experience | 2006 1998* |
CDmdd: EU, Switzerland FDA: USA, Japan (PMDA, STED) Others: China, Kuwait |
Expert Normal Normal |
|
| Business Consulting | 2006 | 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 |
|
| Quality Management | 2006 1998* |
ISO 9001 ISO 13485 Quality System Development and Maintenance Auditing (Internal and Supplier Audits) GAP Analysis |
Normal Expert Expert Expert Expert |
|
| Regulatory Affairs | 2006 1999* |
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 |
|
| Project Management | 2008 1995* |
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 |
|
| Risk Management | 2008 1998* |
Product Risk Management (ISO 14971) Company Risk Management |
Expert Normal |
|
| Interim Management | 2008 | Interim Management as - project manager verification & validation - quality manager, safety engineer - product manager |
Expert | |
| Medical Technology | 2006 1995* |
Product Risk Management (ISO 14971) |
Expert |
|
| Pharma | 2008 | 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
|
|
| Research & Development | 2006 1995* |
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 | 2008 2001* |
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 | 2008 | ISO 13485 GMP Process Validation GAMP4 Software Validation GAMP 5 Lean-Six-Sigma |
Expert Normal Basic Basic Basic |
|
| *=as employee | ||||
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
| Datum | Universität | Studiengang | diploma thesis |
seminar paper |
degree |
| 1987 – 1995 | Technical University of Berlin | Science of Electronics (specialized in Measurement Technology) |
Development of a linear amplifier of high stability and high reliability grade: 1.0 |
PC-based development of a circuit for fast pulse stretching grade: 1.0 |
Diploma |
Lanuguage Skills
| Language | level |
| German | native |
| English | business fluent |
| French | elementary |
Education and Training
| date | company | subject | certificate |
| 09.10.2015 | BB-LIFE / Bio-TOP | Verification & Validation of Packaging for Medical Products | Certificate |
| 25.06.2015 | BB-LIFE / Bio-TOP | Technical Documentation of Medical Products | Certificate |
| 19.06.2015 | BB-LIFE / Bio-TOP | Statistical Planning and Evaluation of Clinical Studies | Certificate |
| 18.06.2015 | BB-LIFE / Bio-TOP | Clinical Studies of Medical Products | Certificate |
| 12.06.2015 | BB-LIFE / Bio-TOP | Changed Role of the QM department in pharmaceutical companies | Certificate |
| 06.05.2015 | BB-LIFE / Bio-TOP | Electronic SOP Management (eSOP) | Certificate |
| 24.04.2015 | BB-LIFE / Bio-TOP | UDI - Unique Device Identification | Certificate |
| 17.10.2014 | BB-LIFE / Bio-TOP | GMP in the Test Laboratory | Certificate |
| 19.09.2014 | BB-LIFE / Bio-TOP | Reconditioning of medical products | Certificate |
| 16.09.2014 | German Society for Regulatory Affairs | GMP / GDP Workshop | Confirmation of participation |
| 23.08.2013 | BB-LIFE / Bio-TOP | Post Market Clinical Follow-up | --- |
| 16.08.2013 | BB-LIFE / Bio-TOP | Supplier management | Certificate |
| 30.05.2013 | BB-LIFE / Bio-TOP | Reprocessing of Medical Devices | Certificate |
| 19.04.2013 | BB-LIFE / Bio-TOP | Qualified Person QP Pharma + Medical Device | Certificate |
| 15.03.2013 | BB-LIFE / Bio-TOP | Medical Devices in Europe | Certificate |
| 15.03.2013 | BB-LIFE / Bio-TOP | Complience Requirements on Life Science Products | --- |
| 21.02.2013 | BB-LIFE / Bio-TOP | 21 CFR part 11 | Certificate |
| 20.02.2013 | BBB.e.V. | IT- laws and safety | --- |
| 24.01.2013 | BBB.e.V. | Workshop Heilmittelwerberecht 2013 | Confirmation of participation |
| 24.01.2013 | CC-ATMP | CC-ATMP Symposium Berlin | Certificate |
| 13.11.2012 | TSB-Berlin | Technology spin-offs & shares | Confirmation of participation |
| 12.11.2012 | BB-LIFE / Bio-TOP | Quality Assurance Production | Certificate |
| 01.11.2012 | TSB-Berlin | Discounted Cash-Flow-Method | Confirmation of participation |
| 30.10.2012 | TSB Berlin | BarCamp Health IT | Confirmation of participation |
| 25.10.2012 | 25.10.2012 BB-LIFE / Bio-TOP | Quality Assurance Software | Certificate |
| 14.09.2012 | BB-LIFE / Bio-TOP | Systems / Tools for Clinical Studies | Certificate |
| 28.08.2012 29.08.2012 |
German Society for Regulatory Affairs |
Update Workshop - Update in Regulatory Affairs for Drugs and Medical Products | Certificate |
| 17.08.2012 | BB-LIFE / Bio-TOP | Medical Products - Safetyplan | Certificate |
| 23.03.2012 | BB-LIFE / Bio-TOP | Usability of Medical Devices (Usability File) |
Certificate |
| 19.01.2012 20.01.2012 |
BB-LIFE / Bio-TOP | Internal Auditor Life Science | Certificate |
| 11.11.2011 | BB-LIFE / Bio-TOP | Combined Products medical equipment + pharmaceutical drug |
Certificate |
| 16.09.2011 | BB-LIFE / Bio-TOP | Development of Case Report Forms (CRFs) | Certificate |
| 26.08.2011 | BB-LIFE / Bio-TOP | Extractable and Leachables | Certificate |
| 09.06.2011 10.06.2011 |
BB-LIFE / Bio-TOP | Sterilization of Medical Products | Certificate |
| 01.04.2011 | BB-LIFE / Bio-TOP | Post Market Surveillance for Medical Equipment |
Certificate |
| 08.02.2011 09.02.2011 10.02.2011 |
Medical Device & Technology Test Expo |
Workshops: - Directive 2007/47/EEC - IEC 60601 3rd Edition - ISO 11607 Sterile Packaging - Usability & Risk, Clinical Evaluation |
Confirmation of participation |
| 26.10.2010 27.10.2010 |
BB-LIFE / Bio-TOP Berlin - Brandenburg |
Reimbursement for Medical Equipment I Reimbursement for Medical Equipment II |
Certificate |
| 23.02.2007 | CLEANICAL GmbH | Forum Prevention in Cleaning and Sterilizing of medical instruments |
--- |
| 06.11.2006 | MED/RAS GmbH | Risk Management | Confirmation of participation |
| 17.10.2005 | W.O.M. AG | Medical Device Consultant | Certificate |
| 2005 | TCC Berlin GmbH | Consultant Coaching / Business plans, Cash-Flow- Planning, Government Subsidies |
Confirmation of participation |
| 19.10.2004 | PROSYSTEM AG | Medical Device Consultant and Safety Representative for Medical Products |
Certificate |
| 16.08.2004 | UNITRONIC AG | Connectivity Workshop, Bluetooth, ZIGBEE | Certificate |
| 14.10.2003 | PROSYSTEM AG | Risk Management acc. EN ISO 14971 | Certificate |
| 04.06.2002 05.06.2002 |
METHOD>PARK | Introduction in Testing of Embedded Systems as well as structured and object-oriented design methods |
Certificate |
| 28.08.2002 | Schwab Projektmanagement | Project Management with MS-Project |
Certificate |
| 02/2002 | MTB OHG, | Management Seminar for Executives | Certificate |
| 1998-2005 | National Instruments | Labview Version 4.1 up to Labview Version 6.1, LabWindows CVI | --- |
References
Our references / customers are NDA protected by non-disclosure-agreements (NDA).
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.