Detailed Curriculum Vitae

Personal Information

Ronald Plock
born in the year 1967 in Germany
unmarried, one daughter with partner

 

Contact data

plock consulting
consulting | quality management | regulatory affairs | research & development |

OFFICE BERLIN:
Hattwichstr. 89, 16548 Glienicke, Germany

Mobile:
Direct:
Email:
url:
+49 (0)177 / 6 00 00 80
+49 (0)33056 / 431-984
Ronald.Plock@plock.me
www.plock.me
Office:
Fax:

+49 (0)33056 / 431-980
+49 (0)33056 / 431-981

www.plockconsulting.com






tl_files/plock.me/img/de/plock.me/Ronald_Plock.JPG

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
Expert
Normal
Expert
Expert
Expert
Expert

Expert

Expert

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)
Usability Engineering (IEC 62366)
Clinical Evaluations (MEDDEV 2.7.1 Rev.3, GHTF sg5 n2r8)
Clinical Studies (ISO 14155, MEDDEV 2.7.3 + 2.7.4, GHTF sg5 n3 + n4)
Normative Standards for medical equipment / products
Specialist for IEC 60601 family
Insulin Infusion Pumps IEC 60601-2-24
Insulin Pens ISO 11608 family
Infusion Equipment EN ISO 8536 family
Biocompability (EN ISO 10993 family)
Sterile Products (cleaning and sterilization, ISO 11137 family)
Combined Products (Pharma-/Medical Product)
Software Development Lifecycle (IEC 62304)
Post Market Surveillancee, CAPA
Product Verification
Product Validation
Usability File (DIN EN 60601-1-6, EN 62366)
Technical Documentation CEmdd (STED Format) / FDA
Labelling, IFU- / Service-Manuals (ISO 980, EN 1041, ISO 15223)
Software Validation, Software Lifecycle Processes (IEC 62304)
REACH, ROHS, ISTA2, UL
Reimbursement of Medical Products in Germany

Expert
Normal
Expert
Normal
Expert
Expert
Expert
Expert
Expert
Normal
Normal
Expert
Normal
Normal
Expert
Normal
Normal
Expert
Expert
Normal
Normal
Normal

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
Expert

Expert













Normal
Normal
Expert
Expert
Normal
Expert
Normal

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.