a janson… · web view- preparation quality system to medical device single audit program...

A

OVERVIEW

Bernd Janson was born in 1968 in Frankfurt am Main and has over 20 years experience in process and quality management for the medical device industry. Working as a freelance journalist and computer science training coach, he worked for several years demanding and pioneering solutions for small, midsize companies also in global / international Projects in the medical device industry. Meanwhile he has several years of experience in compliance and remediation projects (FDA).

QUALITY ASSURANCE (QA)

- Quality management systems according to ISO 9001: 2015 / ISO 13485: 2016

- Technical Writer for Standard Operating Procedures (SOPs, Guidelines), GxP, GMP, GDP

- CAPA, NCR, Complaint handling, Field Actions (FSCA)

- Function as a quality management representative (QMB / BdL)

- Experience with numerous Notified Bodies (f.e. TÜV Süd, TÜV Rheinland, DEKRA)

- FDA, 21 CFR Part 820 (Medical Devices)

- Remediation Projects, Project Management, Interim Manager

REGULATORY AFFAIRS (RA)

- Registration for Medical Devices according to MDD 93/42/EEC and MDR 2017/745

- Registration of in-vitro-Diagnostics IVD 98/79/EC

- Registration and CE marking for products class I, Is, Im, IIa, IIb, III

- Technical Documentation / STED,

- Risk Management ISO 14971, FMEA Analysis

- Function as safety officer for medical devices for 15 years

- Experience with numerous Notified Bodies (f.e. TÜV Süd, TÜV Rheinland, DEKRA)


- Remediation Projects, Project Management, Interim Manager

REMEDIATION PROJECTS / COMPLIANCE EXPERT

- Experience in different Remediation Projects (Global / International/ Midsize Companies)

- Technical Writer for Local / Global SOPs / High-Level Procedures

- CAPA / NCR Remediation Projects, Complaint Handling Remediation Projects


- Project Management, Interim Manager, Teamlead

A. Personal Information

---------------------------------------------------------------------------------------------------------------------------

Name:

Bernd Janson

Address:

In den Wiesen 14

65795 Hattersheim

Mobile:

++49 (0)176 - 270 30 741

E-Mail:

[email protected]

Website:

www.bernd-janson-prozessmanagement.de

Birth:

Sept. 10th, 1968, Frankfurt am Main

Nationality:

German

Family status:

Single

Languages:

German – Fluent (native Language)

English – Excellent working knowledge, written and spoken

B. Education

---------------------------------------------------------------------------------------------------------------------------

2010 – 2012

Goethe Universität, Frankfurt

Faculty "Computer Science"

Without terminating

04/1997 – 07/1997

Verwaltungs- und Wirtschaftakademie (VWA), Frankfurt Practical training for graduates

Focus: "Communication Training"

1988 – 1994

Johannes-Gutenberg-Universität, Mainz Faculty "Political Economy and Economics"

1985 – 1988

Konrad-Adenauer Gymnasium, Kriftel

Graduation from High School (Abitur)

1979 – 1985

Heinrich-Böll-Gymnasium, Hattersheim Secondary School (Realschulabschluss)

1975 – 1979

Robinsonschule, Hattersheim Primary School (Grundschule)

C. Professional Experience (Freelance Projects)

Heinz Kurz GmbH, D-72144 Dusslingen / passive middle-ear implants

Interim Manager for Quality Management and Regulatory Affairs

Jan-2019 until today

Project of Heinz KURZ GmbH for introduction and remodelling the quality system for the new MDR 2017/745 and MDSAP

Tasks / Responsibilities:

Implementation for MDR / MDSAP

- Transmission from MDD 93/42/EWG to MDR 2017/745 requirements

- Remodeling Quality System for MDR requirements:

· Post market Surveillance (PMS)

· Training for Person responsible for compliance (PRRC)

· Reclassification and Product scope

· Clinical Evaluation / PMCF

· Unique Device Identifier (UDI)

- Preparation Quality System to Medical Device Single Audit Program (MDSAP)

· Gap-Analyse to ISO13485:2016

· Transmission Processes to MDSAP requirements

· Internal Audits

- Internal Audits of R&D, Production, RA, QA, Management in 2019 and 2020

TECHNICAL WRITER for Standard-Operation-Procedures (SOPs & Guidelines)

- SOP Audit Program, Auditplans

- SOP Clinical Evaluation / PMCF / Clinical Trial

- SOP Complaint Handling

- SOP Control of documents and records

- SOP Control of non-compliant products

- SOP Corrective and Preventive Actions (CAPA)

- SOP Research and Development

- SOP Feedback from Customer

- SOP Identification and Traceability

- SOP Identification of the products

- SOP Implant card

- SOP Incident reporting / Recalls

- SOP Instructions for Use

- SOP Person responsible for regulatory provisions (PRRC)

- SOP Post Market Surveillance (PSUR)

- SOP Quality Agreements (Suppliers / Dealers)

- SOP Repair Process

- SOP Rework Process

- SOP Risk-based approach

- SOP Supplier management

- SOP Training Process

- SOP Usability Process

Used Systems and Software:

MS Outlook, MS Office, MS Visio, Skype / GoToMeeting

---

CAPA = Corrective and Prevention Actions

NCR = Nonconforming Reports

MDR = Medical Device Regulation

MDSAP = Medical Device Single Audit Program

PMS = Postmarket Surveillance (Marktüberwachung)

PMCF = Postmarket Clinical Follow-up

SOP = Standard Operation Procedure

TAGEDA GmbH, D-78224 Singen (Hohentwiel) / Pharma products

Support for Documentation- and Learning-Management-System (DMS/LMS)

Jan-2018 until April-2018

Support Project of TAKEDA in the Documentation and Learning Management System during the remediation project


Copy Manager

- Print new / changed SOPs & attachments

- Distribution of new / changed SOPs to different locations

- sort out and destroy obsolete SOPs & attachments

Training Officer

- Planning of presence trainings and eLearning trainings (GMP-Trainings)

- Generating and distribute of training records for the trainings

- Reversal of training records back to SAP

Administrative Activities

- Manage appointments

- Manage the digital storage

- Store documents in the local archive (paperbased binders)


SAP, MS Outlook, MS Project

---

GMP = Good Manufacturing PracticeSAP = ERP System

SOP = Standard Operation Procedures

MAQUET Cardiopulmonary GmbH, D-72379 Hechingen / Extracorporeal Life Support

Consultant for Complaint Handling, CAPA and NCR

Sept-2014 until Dez-2017

Remediation Project of MAQUET after the FDA Consent Degree with remediation of the quality system including complaints, NC / CAPA


COMPLAINT BACKLOG TEAM- Creation of a Complaint Backlog Team with 3 external consultants

- Responsible for Complaint Backlog (Supplier Complaints / Internal Complaints)- Investigation, Root cause and Transfer to new non-conformance Process

- close complaints with risk assessment and Correction/Actions.

NC REMEDIATION

- Team lead in NC Remediation Project for Subteam with responsibility

for 6-8 external consultants

- Responsible for evaluation and closure of NCs with Root cause,

Impact Assessment and Correction/Actions

- Reporting results to management

PHÖNIX PROJECT / TIGER TEAMS

- CAPA Owner for FDA Findings

- Following CAPA process, Root Cause Analysis and Correction / Actions

- Presenting CAPAs during FDA Audit to FDA Inspector.

TECHNICAL WRITER for Standard-Operation-Procedures (SOPs & Guidelines)

- SOP “NC Process”- SOP “NCR Process” (for Production)- SOP “SCAR Process”

- SOP “Incoming Receipt of Goods”

- SOP “Blocked Goods”- SOP “Material Locks Process”- SOP “Creation of Inspection Plans”- SOP “Control of test equipment and measuring devices- SOP “Scrap Process”- SOP “Quality Document Process”- SOP “Rework Process”- SOP “Supplier Control Process”


SAP, MS Office 2010, MS Visio, Microsoft DMS

---

CAPA= Corrective And Preventive ActionsNC = Non-Conforming Products (Deviation)SOP= Standard Operation ProcedureSCAR= Supplier Correction Action Request

DePuy SYNTHES / Johnson & Johnson, CH-4528 Zuchwil / Solothurn (Switzerland) /

Implants for reconstruction, trauma and spinal surgery

Consultant and Technical Writer in SYNTHES Global Remediation Quality Plan (GRQP).

Jun-2013 until Sept-2014

Global Remediation Project of DePuy SYNTHES quality system after the takeover of Johnson & Johnson with 22 Sites in USA / 11 Sites in Switzerland.


LEGACY REVIEW

review of records and determination of remediation levels according protocols

- Perform Legacy Review for WS3.3 Raw Material for Instrument

- Perform Legacy Review for WS3.4 Pest Control Records.

- Global Summary Report for WS3.4 Preventive Maintenance.

TECHNICAL WRITER FOR GLOBAL REPORTS

Create in collaboration with GRQP-Team USA for all 22 Sites USA & Switzerland:

- Checklists (CL)

- Site Summary Reports (SSR)

- Global Summary Report (GSR)

- Global Remediation Report (GRR)

TECHNICAL WRITER FOR SOPs

Support to generate new Standard processes in Europe / EMEA in GRQP

for 11 DePuy SYNTHES Sites in Switzerland.

- Blocked Goods

- Houserules Central / Regulation Eating and Drinking

- Line Clearance

- Make To Stock

- Pest Control Management

- Preventive Maintenance

- Raw Material ICDS (High Level SOP)

- Used Tools

- Wateranalysis


SAP, MS Office 2010, MS Visio, Oracle AGILE, WebEx

---

DCR = Document Change RequestDCO = Document Change Order

ICDS = Global Procedure SOP = Standard Operation Procedure

VOLLMAR Werkzeugbau, D-53804 Much / Toolmaker for medical device industry

Consultant in Quality Management / Regulatory Affairs

Feb 2010 until Dec 2017

Introduction and support for the quality system and annual Audits with TÜV Rheinland


Introduction a Quality System according DIN EN ISO 9001:2008.

- Create complete quality documentation (SOPs, Checklists, Manuals)

- generate Quality Manuals (QM Handbuch)

- generate Standard Operation Procedures (SOPs) for

- Guidance of documents and data

- Guidance of records

- Quality goals

- Internal communication

- Order tracking / Auftragserfassung

- Goods receipt / Wareneingang

- Storage / Lagerung

- Customer satisfaction / Kundenzufriedenheit

- Recall / Rückrufe

- Internal Audits

- Corrections and Corrective Actions / CAPA

- Quality & Compliance Plan

- Change Control

- Supplier Quality and Controls / QSV

- Training and implement procedures and working instructions

- Supplier & Customer Complaints

- Represents the management towards the Notified Body TÜV Rheinland


MS Office 2003, MS Visio

---

CAPA = Corrective and Preventive Actions

SOP = Standard Operation Procedure

QSV = Quality Safety Agreements

KLINIKA MEDICAL GMBH, D-61250 USINGEN / Disposable Medical Devices

Project consultant for Quality Management / Regulatory Affairs

2012 until 2015

Project Management for Patents and new products


- Project management for Patent Issues

- Research for new products (MDD / IVD)

- Internet research


MS Office 2010, Internet Webbrowser

---

MDD = Medical Device Directive 93/42 EWG

IVD= InVitro Directive 98/79/EC

BERND JANSON IT-SERVICE AND MANAGEMENT CONSULTING, D-65795 HATTERSHEIM / Consulting company for Quality and ITFreelancer / Owner

2003 until 2009

Consulting for quality systems and different and Webdesign customers


- Consultant for Quality Management ISO13485 / ISO 9001

- Webdesign (Apache, PHP, JavaScript, HTML)

- Different customers for Websites


MS Office 2000, Frontpage 2000, Apache Server 4, HTML 4

FRESENIUS AG (Heute: Fresenius SE & Co. KGaA), D-61352 BAD HOMBURG

IT-Trainer for MS-Office and Windows applications

1994 until 1997

Freelance IT-Trainer for Windows applications and MS Office


- Performing In-house trainings at the IT- Training Center of Fresenius AG

- DOS- and Windows-Systems

- MS-Office 4.2 (Word, Excel, PowerPoint, Access)

- Lotus Smart Suite / Lotus Notes

- Databases (Dbase IV)

IT PROJECTS & SUPPORT:

- Introduction CITT Fax-System Firma Acotec (1995)

- E-Mail-Systems MS-Mail / Lotus Mail (1995)

- Access-Database of the complete IT-Infrastructure

for all 9 Fresenius Sites in the Rhein-Main Area (1996).


MS Office 4.2, Wordperfect, Lotus Mail, Lotus 1-2-3

D. Professional Experience (Permanent / Freelance)

---------------------------------------------------------------------------------------------------------------------------

KLINIKA Medical GmbH, D-61250 Usingen / Disposable Medical Products

Quality Assurance Manager / Regulatory Affairs Manager / Safety Commissioner for medical devices (permanent 1997 until 2003, on a freelance basis 2003 until 2012)

Jun 1997 until Jun 2012

Quality Assurance Manager (QA)

- Implement Quality Management System DIN EN ISO 9002 / ISO 13485

- responsible for complete quality documentation (SOPs, Checklists, Manuals)- Generating Quality Manuals (QM Handbuch)- complaint handling and field actions (FSN / FSCA)

- responsible for Quality Systems and internal Audits

- Supplier Quality, Supplier Audits and Contracting (QSV)

- represents the management towards the Notified Body, Food and Drugs

Administration, certification bodies or governmental agencies

Regulatory Affairs Manager (RA)- responsible for certification,

- CE marking and technical files for the following product groups: - anaesthesia- and critical care products class I, Is, Im, IIa, IIb, III- Medical Devices Disposables (f.e. I.V. cannula, catheters, customer procedures sets, suction tubes, gloves, urine-bags, etc.)- Medical Devices Active Systems (f.e. CPAP-Monitoring-Systems including equipment)

- Certifications against Medical Device Directive 93/42/EEC annex II, annex V/VII (MDD) - InVitro Devices (f.e. In-Vitro-Diagnostics like arterial bloodsampler, venous blood collection systems, capillar blood systems, bloodgas sampler)

- Certifications against In-Vitro Directive 98/79/EEC Annex III

- responsible for:

- Technical files (CE)

- Design History File (DHF)

- Device Master Record (DMR)

- Device History Record (DHR)

- Risk management files ISO 14971

- Failure Mode and Effect Analysis FMEA

- Test methods and validation

Safety Commissioner for medical devices (1999 until 2012, §31 MPG)

- collect and evaluate notifications of medical device risks

- coordination of corrections / actions

- fulfilment of reporting obligations (f.e. MDR: Medical Device Reporting)

- BfArM / FDA Reporting

IT Support

- Construction and Support KLINIKA Website (2004 until 2012)

Sales & Customer Service- Generating of Quotes / Offers to customers

- Shipping of product samples to customers

- Sales service


MS Office, PROFAKT

---

BfArM= Bundesinstitut für Arzneitmittel und Medizinprodukte /

Federal Institute for Drugs and Medical Devices

CPAP= Continuous Positive Airway Pressure

DHF= Design History Files

DHR= Device History RecordDMR= Device Master Record

FDA= Food and Drug Agency

FMEA= Failure Mode and Effect Analysis FMEA

I.V.= Intra Venouse

MDD= Medical Device Directive 93/42/EEC

QSV= Quality Safety Agreements

SOP= Standard Opertion Procedure

E. Further Education

---------------------------------------------------------------------------------------------------------------------------

Further Education for Quality Management / Regulatory Affaires

Time

Course / Event

2020-04

2017-12

2016-10

2010-02

2002-09

2002-09

Risk Management ISO 14971:2019

TÜV Rheinland

Medical Device Regulation (MDR) im Detail

TÜV Süd, Stuttgart

Revision EN ISO 13485:2016

Jürgen Lütcke (Lütcke Consulting), Pates Experts

DIN EN ISO 9001:2008

Klaus Seiler (MSc.)

Risc Management ISO 14971


Practical implementation of the Medical Devices Act (MPG)

Training for medical device consultant (§30 MPG)

Training for safety officer of Medical Devices (§31 MPG)

Module 1,2 and 3 for Manufacturer of Medical Devices


---

DIN= Deutsches Institut für Normung / German Institute for Standardization

ISO= International Standard Organization

MPG= Medizinproduktegesetz / Medical Device Act

Date

19-JAN-2021

Location

Hattersheim

Bernd Janson – In den Wiesen 14 – 65795 Hattersheim – GERMANYMobile 0176 270 30 741 - E-Mail: [email protected] more Information visit: www.bernd-janson-prozessmanagement.de

Page 14 of 14

:

a janson… · web view- preparation quality system to medical device single audit program...

Documents