Staffing - Medical Devices
|
|
- Brianne Esther Stokes
- 6 years ago
- Views:
Transcription
1 Staffing - Medical Devices LONDON GENEVA SINGAPORE DUBLIN procorre.com 1
2 Implementing solutions to clients worldwide 2
3 Contents Services 04 Sector Overview 07 Medical Devices 07 In-Vitro Diagnostics 08 Overview of ISO13485: Regulatory Affairs 12 Quality Assurance 14 Research & Development 16 Engineers 18 Summary 20 Contact Us 21 3
4 Services Procorre is a global professional services consultancy trusted to deliver experienced consultants worldwide. Partnering with Procorre will give you access to our pool of expert consultants from varied sectors and specialisms, enabling you to place the highest calibre consultants you need. We are experts in sourcing talent, global mobility and managing projects across a range of industries. We re able to offer a range of project services to manage projects from inception to completion, through the entire project life cycle. 4
5 Services Our teams are able to deliver a human capital management process designed for your individual needs in any country. Procorre International Project Services: Supplying consultants for projects - over 1,500 consultants deployed worldwide Access to our global network of consultants Life cycle global mobility in over 120 countries Contractor management Outsourcing options We trust that in an ever changing environment partnering with Procorre will add value to your business, reduce risk and deliver projects on time. 5
6 Services Having established an excellent working relationship with all the notified bodies in Europe since 1996 and as recognised world leaders in our field of expertise, Procorre are working in partnership with European Device Solutions Ltd, to offer all our global clients a complete range of services to ensure their medical and in-vitro devices are compliant with the latest standards. As recognised world leaders in our field of expertise with the medical devices industry, Procorre are looking to work with contractors in: Regulatory Affairs (page 12) Quality Assurance (page 14) Research & Development (page 16) Engineers - Manufacturing, Validation and Production (page 18) Working in partnership with European Device Solutions Ltd, Procorre are representing businesses and products through registration for CE mark, complaint handling and deal with any incident reports which may arise in the future. 6
7 Sector Overview Medical Devices Medical devices have a significant importance to our lives as without them we would not be able to diagnose medical conditions, treat diseases or improve our quality of life. Medical devices can range from a one off usage, for example a syringe or bandage, to implants and larger imaging machines such as an MRI or X-ray machine. Devices fall into three classifications - Class I, Class II and Class III. The class classification is risk based due to the nature of the product, the associated risk to the patient and the regulatory levels required to get the device to market. 1. Class I - General Controls: example - bandages and stethoscopes 2. Class II - General Controls and Special Controls: example - pregnancy kits and X-ray machines 3. Class III - General Controls and Pre-market Approval: example - breast implants and pacemakers 7
8 Sector Overview In-Vitro Diagnostics In-Vitro Diagnostics (IVD) is an important segment in the global healthcare industry due to the rapid growth in the market place as a result of technological advancements, better diagnostic tools, improved treatment monitoring, and increased availability of overthe-counter tests. IVDs add significant value to treatment processes and medical diagnoses, enhancing the well-being of the general public. IVDs must comply with the new IVD Regulation (IVDR) a revised set of regulatory requirements to gain a CE Mark for any product. The aim of the directive is to ensure patient health and safety, by achieving performance levels set out by the manufacturer, for their products to comply with essential requirements. 1. Class A - Low risk products: example - clinical chemistry analyser 2. Class B - Slightly higher risk: example - pregnancy self-testing 3. Class C - Slightly higher risk again (with addition of pre-market submission of technical info to notified bodies): example - blood glucose self-testing 4. Class D - Higher risk products: example - HIV blood donor screening 8
9 Overview of ISO13485:2016 Changes to ISO13485:2016 have placed a greater emphasis on Quality Assurance and Regulatory Affairs. Over the next few years, ISO13485:2016 will allow manufacturers, accreditation or certification bodies and regulators time for transition to the new standard. 9
10 Overview of ISO13485:2016 A significant driver of the revision was the need for a global harmonised platform for quality systems and emphasising risk management throughout a quality system. This means any Medical Device (MD) or In-Vitro Diagnostic (IVD) that doesn t comply with the new ISO13485:2016 standards in the set timeframe will be refused access to key markets including the EU and US. The new standard requires 80 per cent of products that previously didn t require intervention from notified bodies as self-test or Class B, will now need to be reviewed based on revised classification. 10
11 Overview of ISO13485:2016 ISO13485:2016 will have huge implications for manufacturers and third party suppliers, who now have less than three years to upgrade their quality management systems (QMS) to ensure medical organisations can operate lawfully. The regulatory changes mean the industry is facing an international shortage of medical device contractors, who are qualified to support the sheer volume of organisations needing to upgrade or replace their products ahead of the fast-approaching deadlines. For example it is estimated that around 300,000 QA contractors alone will be required, though currently only about 36,000 have the relevant expertise. 11
12 Regulatory Affairs Regulatory Affairs (RA) specialists have a unique skillset with a combination of scientific, legal and corporate awareness. They are actively involved in every phase of the development of the medical device life cycle, including manufacturing and marketing of the device. Responsibilities include regulatory compliance, liaising with notified bodies, state, local regulatory agencies and advising companies on their regulatory duties. Procorre are looking to place RAs with the following levels of experience: Affairs Assistant Vice-President Officer / Executive / Associate Associate Director / Director Senior Officer / Senior Executive / Senior Associate Manager / Senior Manager Specialist Project Manager 12
13 Regulatory Affairs Our consultants have worked across the following specialist areas: UK Regulatory Affairs EU Regulatory Affairs International / Global Regulatory Affairs Emerging Markets Regulatory Affairs Regulatory Operations Chemistry, Manufacturing and Controls (CMC) Regulatory Artwork / Labelling The regulatory function in the healthcare sector is vital in making sure safe and effective healthcare products are available worldwide. We have RA professionals who can ensure regulatory compliance, prepare submissions for the necessary licensing, marketing and legal components, in order for products to be allowed entry into the market place. 13
14 Quality Assurance Quality issues rightly concern every stakeholder in the medical device industry, from manufacturers and regulators to suppliers, doctors and patients. The media attention surrounding quality control has increased over recent years and the punishments are severe when it comes to quality issues. We defined the optimum level of quality as the one that reliably meets or exceeds the expectations of customers and regulators while maximising competitive advantage and shareholder value. A company s quality performance can affect its business performance, which is why we offer the best in the field, offering the best practices. We understand that Quality Assurance (QA) is a diverse role which can often vary depending on what a company produce, the market place, regulatory authorities and the procedures put in place. QA professionals require a number of key skills ranging from auditing, handling customer complaints, generating reports, managing validation and leading investigations. Our QA experts are responsible for the development and manufacturing medical devices to ensure the process is performed in compliance with regulatory requirements. 14
15 Quality Assurance As our QA professionals influence working practices and improve standards of quality, we only place individuals of the highest calibre in a variety of key roles across different projects, processes and global locations. Procorre are working with QAs with the following levels of experience: Quality Administrators QA Manager QA Auditor QA Officer / Quality Officer Quality Specialists Head of Quality Qualified Person (QP) 15
16 Research & Development Medical device research & development (R&D) teams are constantly facing a number of business and regulatory challenges, resulting in longer product development cycles and escalating product costs. With an increase in demand for medical devices in particular from emerging markets, this has led to an acceleration of product adaptation for these markets - putting increased pressure with limited resources to cope with the demand. At Procorre we have an in-depth knowledge which enables us to understand and ensure that we only provide the highest calibre of R&D to all our clients. We cover a wide range of roles across the clinical, science, pharmaceutical, biotechnology industries as well as medical device and engineering sectors. 16
17 Research & Development Procorre Consultants have extensive specialist knowledge of the R&D market, this means we can provide the best talent and staff major projects around the world. Procorre are looking to place R&D specialists with the following key skills: Computational Chemistry Analytical Chemistry Formulation Chemistry Process Chemistry / Scale Up Organic / Medicinal Chemistry Molecular Biology Cellular Biology Pharmacology Structural Biology Genetics 17
18 Engineers Procorre understands the unique requirements companies within medical device development face when resourcing. Engineering roles in particular can be diverse, which is why we are able to identify, place and manage an entire workforce, to address a client s unique requirement and challenges in areas of skill and regulatory compliance. All our specialist engineers have an extensive knowledge of economics, mathematics and science. Their knowledge base ensures they are not only strong problem solvers but they have the abilities to concept, design and test theories in order to be developed to a large scale production. 18
19 Engineers Engineering skill sets can vary greatly but some of the key specialties we provide are: Facilities Engineer Controls Engineer Process Engineer Automation Engineer Chemical Engineer Electrical Engineer Bioprocess Engineer Software Engineer Production Engineer Product Technologist Quality Engineer Mechanical Engineer 19
20 Summary Your business will prosper by partnering with Procorre. Our advice and consultancy services allows us to manage the entire project life cycle providing: expert project services; trusted talent mangement; and efficient global mobility. Project Services By engaging our project services, Procorre will guide you through challenging periods of transition, identify opportunities, manage risks and design effective, competent organisational structures. Talent Management Using our talent management services ensures that you appoint proven, high calibre professionals to successfully complete your projects. Global Mobility Our global mobility services will help you expand into new markets and satisfy diverse legal and regulatory requirements. We also help consultants arrive in country, on time; eliminating any distractions from executing your projects to exemplary standards. 20
21 Contact Us Partnering with Procorre can boost your projects chances of running to cost, time and quality. Contact us to find out more about our comprehensive services or explore a bespoke package of services to meet your business distinct needs. Ireland: UK: Singapore:
22 LONDON GENEVA SINGAPORE DUBLIN Registered Address: Procorre, 33 Ubi Avenue 3, #08-61, Singapore T F PC00560_001
Consultants GENEVA SINGAPORE DUBLIN LONDON. procorre.com
Consultants LONDON GENEVA SINGAPORE DUBLIN procorre.com 1 2 The best consultants choose Contents Who are Procorre? 04 Our Services 06 Talent Management 08 Global Mobility 12 Project Services 18 Procorre
More informationThe implications of the new EU Medical Device Regulation on Combination Product Packaging
The implications of the new EU Medical Device Regulation on Combination Product Packaging June 2017 ANDREW LOVE VP Capability Development Be4ward Ltd Introduction Be4ward Andrew Love www.andrewrlove.com
More informationThe implications of the new EU Medical Device Regulation on Combination Product Packaging
The implications of the new EU Medical Device Regulation on Combination Product Packaging ANDREW LOVE VP Capability Development Be4ward Ltd Introduction Be4ward Andrew Love www.andrewrlove.com A niche
More informationUNANNOUNCED EU MEDICAL DEVICE AUDITS BY NOTIFIED BODIES: IMPACT ON SUPPLIERS
UNANNOUNCED EU MEDICAL DEVICE AUDITS BY NOTIFIED BODIES: IMPACT ON SUPPLIERS Executive Summary European Medicines Agency (EMA) regulations for licensing of medical devices include the use of authorized
More informationIn the huge expanse of Asia, Singapore and
New Medical Device Regulation 16 February 2009 By Ames Gross In the huge expanse of Asia, Singapore and Hong Kong are small places. However, after Japan, they are among the most advanced medical markets
More informationA Global CRO STRONGER TOGETHER
A Global CRO STRONGER TOGETHER About us Unique Service Offering the first agrochemical CRO to offer a truly global service Part of the Eurofins Scientific Group of companies, Eurofins Agroscience Services
More informationFlexible, robust solutions from BSI. An In Vitro Diagnostic Notified Body. Expertise and experience. IVD regulatory solutions
Flexible, robust solutions from BSI An In Vitro Diagnostic Notified Body Expertise and experience IVD regulatory solutions Updated May 2017 Your guide to the In Vitro Diagnostic Directive The purpose of
More informationThe In Vitro Diagnostic CRO
The In Vitro Diagnostic CRO Choose Beaufort Because of Our People, Processes and Proven Experience The value of expertise cannot be overstated, especially when it comes to streamlining complicated in vitro
More informationEffective competence assurance management is as easy as itb. competence assurance
Effective competence assurance management is as easy as itb. competence assurance We want all our clients to realise the full potential of their workforce by delivering professional and fit for purpose
More informationOptimising the Contribution of Regulatory Affairs to Product Development, Maintenance and Commercialisation
TOPRA MODULE Optimising the Contribution of Regulatory Affairs to Product Development, Maintenance and Commercialisation Case study 2 - Management of Regulatory Affairs Department ENABLING AND PROMOTING
More informationMarket surveillance of medical devices
Market surveillance of medical devices A Joint Action to reinforce public health protection and medical devices monitoring by implementing joint manufacturer inspections and improving clinical process
More informationThe postholder will work as a key member of the senior team for Organisational Learning and Development.
JOB TITLE: BAND: BASE: RESPONSIBLE TO: ACCOUNTABLE TO: OD Consultant AFC 8b XX Director of L&D and OD Director of L&D and OD JOB SUMMARY To provide specialist OD consultancy expertise and support to the
More informationPortfolio Guidance Notes The RCT Evidence Criteria Radiation Physics
Page 1 of 5 Portfolio Guidance Notes The RCT Evidence Criteria Radiation Physics In order to demonstrate to The RCT assessment panel that you are working at a sufficient level, it is necessary to produce
More informationKINGSMANN CARE GROUP
PHARMA CONSULTANTS KINGSMANN CARE GROUP KINGSMANN CONSULTANCY SERVICES Thank you for taking interest in Kingsmann Consultancy Services. Kingsmann Consultancy (KC) is a leading business development-consulting
More informationInternal audit effectiveness reviews. Working in partnership to help you enhance the quality and effectiveness of your internal audit function
Internal audit effectiveness reviews Working in partnership to help you enhance the quality and effectiveness of your internal audit function A changing environment Since the 2008 financial crisis it is
More informationRegulation of software a medical device
Regulation of software a medical device IOF-TTO Event 17.10.2017 Steve Eglem Responsible of clinical investigation @ famhp Member of the medical device European Clinical and Evaluation (CIE) working group
More informationGxP Auditing, Remediation, and Staff Augmentation
GxP Auditing, Remediation, and Staff Augmentation TABLE OF CONTENTS 3 Introduction 4 GxP Auditing 4 GMP Auditing 5 GCP Auditing 5 GLP Auditing 6 Pharmacovigilance Auditing 6 Vendor/Supplier Auditing 7
More informationThe European Medical Technology Industry. in figures / 2018
The European Medical Technology Industry in figures / 2018 Table of contents What is Medical Technology? 4 Innovation 10 Employment 14 Companies 18 Expenditure on Medical Technology 20 MedTech Market in
More informationMedical Device Regulatory Framework 9 SEPTEMBER 2015 FUNDISA CONFERENCE JANE ROGERS
Medical Device Regulatory Framework 9 SEPTEMBER 2015 FUNDISA CONFERENCE JANE ROGERS Key Topics Definitions Essential Principles Classification Conformity Assessment Framework License to Manufacture, Import,
More informationSysmex Introduction and Africa Overview. Eric Osei General Manager West & Central Africa
Sysmex Introduction and Africa Overview Eric Osei General Manager West & Central Africa Sysmex Corporation, Japan Head Office Established 1968 Business Field Position in the IVD Kobe, Japan IVD, IT, Scientific
More informationGuide for Manufacturers and Sponsors on Clinical Investigations Carried Out in Ireland
Guide for Manufacturers and Sponsors on Clinical Investigations Carried Out in Ireland AUT-G0095-1 15 AUGUST 2014 This guide does not purport to be an interpretation of law and/or regulations and is for
More informationHealthcare logistics. Business Solution. Individual logistic solutions out of one hand
Business Solution Healthcare logistics Arvato provides individual logistics solutions for pharmaceutical and medical technology companies across Europe for all product categories and temperature ranges.
More informationCambridge Commodities Ltd QUALITY MATTERS
Cambridge Commodities Ltd QUALITY MATTERS contents Quality at CCL Meet the quality team New supplier and material approvals FTIR investigation Positive release Repack process Regulatory and technical support
More informationGxP Auditing, Remediation, and Staff Augmentation
GxP Auditing, Remediation, and Staff Augmentation TABLE OF CONTENTS 3 Introduction 4 GxP Auditing 4 GMP Auditing 5 GCP Auditing 6 GLP Auditing 7 Pharmacovigilance Auditing 7 Vendor/Supplier Auditing 8
More informationSupply of aseptically - prepared doses of IMPs across legal boundaries. Edition 1. December 2017
Supply of aseptically - prepared doses of IMPs across legal boundaries Edition 1 December 2017 Endorsed and supported by: NHS Pharmaceutical Quality Assurance Committee 2017 with National Pharmacy Clinical
More informationCell Therapy Services Your Product. Our Passion.
Pharma&Biotech Cell Therapy Services Your Product. Our Passion. Complete Portfolio of Services for cgmp Manufacturing of Cell-based Products Pharma&Biotech Cell Therapy Services for cgmp Manufacturing
More informationGloucestershire Hospitals NHS Foundation Trust
Gloucestershire Hospitals NHS Foundation Trust 2009-10 Audit Planning Memorandum March 2009 Gloucestershire Hospitals NHSFT - 2009-10 Audit Plan Contents Page 1 Executive Summary 1 2 Principal accounts
More informationJOB DESCRIPTION. Agenda for Change Band 8a equivalent
JOB DESCRIPTION JOB TITLE: GRADE: DEPARTMENT: LOCATION: RESPONSIBLE TO: Quality Manager Agenda for Change Band 8a equivalent Reference Services @ STH Guy s and St Thomas Hospital Service Delivery Manager
More informationRecast Medical Device directives Impacts on materiovigilance
Recast Medical Device directives Impacts on materiovigilance Journée Vigilance 23.03.2017 Valérie Nys Revision of the EU Medical Devices Legislation Directive 90/385/EEC on active implantable medical devices
More informationASQ Tappan Zee Section Medical Devices, New Regulations and Standards. 26 th September / V. Fischer / Rev. 01
ASQ Tappan Zee Section Medical Devices, New Regulations and Standards 26 th September / V. Fischer / Rev. 01 Agenda Medical Device, General Aspects Examples Quality System(s) New Regulations & Standards
More informationGood morning ladies and gentlemen, Thank you for inviting me to talk about the IVD industry.
Good morning ladies and gentlemen, Thank you for inviting me to talk about the IVD industry. We are entering a new era of much needed regulatory oversight which might seem a daunting task at first. I am
More informationStandards of proficiency. Biomedical scientists
Standards of proficiency Biomedical scientists Contents Foreword 1 Introduction 3 Standards of proficiency 7 Foreword We are pleased to present the Health and Care Professions Council s standards of proficiency
More informationTHE GENERAL DATA PROTECTION REGULATION: GUIDANCE ON THE ROLE OF THE DATA PROTECTION OFFICER
THE GENERAL DATA PROTECTION REGULATION: GUIDANCE ON THE ROLE OF THE DATA PROTECTION OFFICER Contents 1 Introduction 2 2 Key messages 3 3 The requirement to appoint a Data Protection Officer 4 3.1 Public
More informationJob Description. Reporting to: Clinically: Consultant Haematologist Managerially: Director of Quality and Laboratory Operations Managers
Job Description Job Title: Location: Blood Transfusion Compliance Lead 60 Whitfield Street Laboratories, London Reporting to: Clinically: Consultant Haematologist Managerially: Director of Quality and
More informationUpdate on Recast of IVD Directive
Update on Recast of IVD Directive www.pei.de IVD Classification In-house Assays EU Reference Laboratories C M Nübling, PEI Concerns identified by the European Commission in the Medical Devices Roadmap
More informationThe Medical Device Coordination Group: a new Authority Under EU Device Regulations
The Medical Device Coordination Group: a new Authority Under EU Device Regulations By Robert D. Cumming and Nancy W. Mathewson, Esq. This article discusses the organization and functions of the Medical
More informationCOPE. FAQs CORPORATE ONCOLOGY PROGRAM FOR EMPLOYEES
COPE CORPORATE ONCOLOGY PROGRAM FOR EMPLOYEES FAQs This brochure addresses FAQ and is prepared solely for the German market. Local adjustments may be necessary. Please contact us if you require additional
More informationBetter insights, better decisions, better outcomes
Better insights, better decisions, better outcomes Using analytics in healthcare www.pwc.co.uk Contents Introduction 1 Why analytics matter 2 Responding to your needs 4 Demand and capacity planning 5 Closing
More informationQuality Manual. Print Name Title Date Prepared by L Naughton QA Consultant 9 th April 09. Reviewed by Bernard Lennon Fire and Safety Officer
Quality Manual Print Name Title Date Prepared by L Naughton QA Consultant 9 th April 09 Reviewed by Bernard Lennon Fire and Safety Officer 9 th April 09 Corporate Authorisation Joe Hoare Estates Officer
More informationDi Renzo Regulatory Affairs ROME - MILAN - LONDON
Di Renzo Regulatory Affairs ROME - MILAN - LONDON Di Renzo Regulatory Affairs In 1985, Di Renzo Regulatory Affairs began its regulatory consulting for medicines for human and veterinary use, food and dietary
More informationUpdate on Regulatory Environment- Europe Experience with 2007/47/EC M5 & Discussions on Possible Recast of EU Medical Device Regulations
Update on Regulatory Environment- Europe Experience with 2007/47/EC M5 & Discussions on Possible Recast of EU Medical Device Regulations Paul Brooks Vice President Healthcare, Americas Presentation to:
More informationHSE Integrated Risk Management Policy. Part 1. Managing Risk in Everyday Practice Guidance for Managers
HSE Integrated Risk Management Policy Part 1 Managing Risk in Everyday Practice Guidance for Managers HSE Integrated Risk Management Policy Part 1 Managing Risk in Everyday Practice Guidance for Managers
More informationPosition Description
Position Description Position: Reports To: Direct Reports: Chief Executive Officer IFL- 247 Board of Directors Corporate Services Manager Health Services Manager Senior Medical Officer Purpose of the Role
More informationResponsible Sourcing Policy
June 2015 Document Owner Group Procurement Version 5.1 Date of Issue 08 June 2015 Creation Date: June 2015 Page 2 of 13 1 Purpose, Scope & Priorities 1.1 Purpose The purpose of this document is to describe
More informationQualified Persons in the Pharmaceutical Industry Study Guide
Qualified Persons in the Pharmaceutical Industry Study Guide Guide to the knowledge and practical experience required by Qualified Persons relating to pharmaceutical manufacturing in the UK February 2013
More informationCONTINUING PROFESSIONAL DEVELOPMENT (CPD) POLICY
Date originally generated June 06 Date of this version April 2014 Revision number 5 Number of pages 10 Effective date 01 April 2014 CONTINUING PROFESSIONAL DEVELOPMENT (CPD) POLICY 1. INTRODUCTION 1.1
More informationWhy a GSK apprenticeship?
www.gsk.com/apprenticeships Why a GSK apprenticeship? My engineering apprenticeship has given me the boost to further my engineering career and education in the future. Alastair, Maintenance electrician
More informationMEDICAL DEVICES PROGRAMME
MEDICAL DEVICES PROGRAMME 3-4 October 2017 Medical Devices Symposium, updated 29August 2017, external Page 1 Working Party Margareth Jorvid LSM Group, Sweden (Chair) Michael Kipping MHRA, UK Janine Jamieson
More informationQuantifiable Benefits Achieved by ISO 9001 Clients Certified by QMS International Results from 2016 Client Survey
Quantifiable Benefits Achieved by ISO 9001 Clients Certified by QMS International Results from 2016 Client Survey Sector ISO 9001 Benefits Additional Standard Benefits Agriculture Charity "As a team we
More informationQualified Persons in the Pharmaceutical Industry. Code of Practice. March 2008
Qualified Persons in the Pharmaceutical Industry Code of Practice March 2008 Updated October 2009 Code of Practice for Qualified Persons 1. INTRODUCTION... 1 2. REGULATORY BASIS FOR THE QUALIFIED PERSON...
More informationEAST KENT HOSPITALS UNIVERSITY NHS FOUNDATION TRUST
EAST KENT HOSPITALS UNIVERSITY NHS FOUNDATION TRUST REPORT TO: BOARD OF DIRECTORS DATE: 7 AUGUST 2015 SUBJECT: REPORT FROM: PURPOSE: SIX MONTHLY HEALTH & SAFETY AND ESTATES STATUTORY COMPLIANCE REPORT
More informationProduction-based pharmacist a fascinating job.
www.mybayerjob.com Production-based pharmacist a fascinating job These are the interesting tasks that our pharmacists typically undertake in entry-level positions in Production at Bayer HealthCare Pharmaceuticals
More informationMedical Devices. LATVIA LAWIN Klavins & Slaidins
Medical Devices LATVIA LAWIN Klavins & Slaidins CONTACT INFORMATION Sarmis Spilbergs LAWIN Klavins & Slaidins Elizabetes 15, Riga, LV 1010, Latvia +371 67814848 sarmis.spilbergs@lawin.lv www.lawin.com
More informationQuality Management System
Quality Management System ZYQ Testing Laboratory 11111 Testing Avenue Testing Town, Alaska 22222 (555) 555-5555 Date Prepared: January 19, 2009 1 Please note that this Quality Management System (QM) was
More informationRISK MANAGEMENT STRATEGY
Agenda Item No: 15 RISK MANAGEMENT STRATEGY PURPOSE: The Risk Management Strategy has been updated to reflect the revised approach to the Corporate Risk Register and Board Assurance Framework and to reflect
More informationREGULATORY RESOURCES GROUP. a different approach. a range of services to suit your needs
a different approach a range of services to suit your needs A Different Approach... About Regulatory Resources Group Established in 1990, RRG provides a range of regulatory services to the pharmaceutical
More informationLEVERAGING YOUR VENDORS TO SUPPORT DATA INTEGRITY:
LEVERAGING YOUR VENDORS TO SUPPORT DATA INTEGRITY: QUESTIONS TO ASK AND RESPONSIBILITIES TO DOCUMENT Heather Longden Boston Chapter Educational Meeting April 2018 About Waters Lab Informatics Separations
More informationUpdate on the IVDR. Sue Spencer
Update on the IVDR Sue Spencer Caution The new regulations are draft the principles have now been agreed but the Annexes are subject to minor changes Further details will be added later pre and post application
More informationQuality Management System Guidance. ISO 9001:2015 Clause-by-clause Interpretation
Quality Management System Guidance ISO 9001:2015 Clause-by-clause Interpretation Table of Contents 1 INTRODUCTION... 4 1.1 IMPLEMENTATION & DEVELOPMENT... 5 1.2 MANAGING THE CHANGE... 5 1.3 TOP MANAGEMENT
More informationQuality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702
Quality Management System MANUAL SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702 Doc. No. G5500 Rev. 11 Status : APPROVED Effective: 09/07/2017 Page 2 of 32 Quality Manual Table of Contents
More informationGxP Auditing, Remediation, and Quality System Resourcing
GxP Auditing, Remediation, and Quality System Resourcing TABLE OF CONTENTS 3 Introduction 4 GxP Auditing 4 GMP Auditing 5 GCP Auditing 6 GLP Auditing 7 Pharmacovigilance Auditing 7 Vendor/Supplier Auditing
More informationFTA Ireland Membership 2015 DELIVERING SAFE, EFFICIENT, SUSTAINABLE LOGISTICS
FTA Ireland Membership 2015 DELIVERING SAFE, EFFICIENT, SUSTAINABLE LOGISTICS FTA Ireland is a trade association representing the transport interests of members and works to ensure the safest, most efficient
More informationThe New EU IVDR. Overview of the Main Changes & Clinical Data Requirements. Advance Regulatory Consulting Ltd.
Overview of the Main Changes & Clinical Data Requirements Advance Regulatory Consulting Ltd. : Timeline: Entry in to force Q2 (Apr) 2017 Adoption: +6m NB s apply for designation IVDs classified as Class
More informationMedical Device Single Audit Program (MDSAP) An Overview Canadian Experience
Medical Device Single Audit Program (MDSAP) An Overview Canadian Experience Linda Chatwin Sr. Customer Solutions Consultant : 360-817-5556 : linda.chatwin@ul.com LINDA M CHATWIN, Esq, RAC Biography Ms.
More informationJob description and person specification
Job description and person specification Position Job title Head of Genomics Unit Directorate Finance, Commercial and Specialised Commissioning Pay band AFC Band 9 Responsible to Director of Strategy and
More informationSmall Scale Bio-Manufacturing for Clinical Trails; an Introduction to the Clinical Biotechnology Centre
Small Scale Bio-Manufacturing for Clinical Trails; an Introduction to the Clinical Biotechnology Centre Keith Williams Business Development Manager - Clinical Biotechnology Centre CBC - Aims and Objectives
More informationSirtex Medical Limited
Sirtex Medical Limited Market Update 2011 Half Year Results Gilman Wong CEO Darren Smith CFO 9-10 March 2011 SIR-Spheres is a registered trademark of Sirtex SIR-Spheres Pty Ltd. Understanding the Sirtex
More informationPoint-of-care testing (POCT) Requirements for quality and competence
DRAFT INTERNATIONAL STANDARD ISO/DIS 22870 ISO/TC 212 Voting begins on: 2004-07-12 Secretariat: ANSI Voting terminates on: 2004-12-13 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ
More informationGS1 Guide on Unique Device Identification (UDI) implementation
GS1 Guide on Unique Device Identification (UDI) implementation This document aims at providing clarification to questions raised by the industry as well as implementation guidance on the use of GS1 standards.
More informationBS2482 TIMBER BOARDS ASSESSMENT REPORT. Assessment Summary
BS2482 TIMBER BOARDS ASSESSMENT REPORT : Category: Manufacturer Manufacturer Manufacturer Manufacturer Location: Name: Location Location Location Location Previous Assessment Category: N/A Meeting With:
More informationMDI Manufacturing Services
MDI Manufacturing Services Presenter, Date Who we are 3M Drug Delivery Systems is a division of 3M dedicated to working together with pharmaceutical and biotech companies to bring new and improved products
More informationMEDICAL DEVICE CLINICAL INVESTIGATIONS AND ISO 14155
MEDICAL DEVICE CLINICAL INVESTIGATIONS AND ISO 14155 EXECUTIVE SUMMARY Medical device regulations around the world generally require manufacturers of most types of medical devices to supply data as part
More informationPanel Discussion: European Medical Device Regulations Preparing for the Storm Moderator: Lenita Y. Sims Spears, Senior Quality Consultant/Senior
Panel Discussion: European Medical Device Regulations Preparing for the Storm Moderator: Lenita Y. Sims Spears, Senior Quality Consultant/Senior Regulatory and Compliance Counsel, BioTeknica Panelists:
More informationDiscussion Paper on the Validation of Pharmacovigilance Software provided via SaaS
Discussion Paper on the Validation of Pharmacovigilance Software provided via SaaS June 2012 K Edmonds Page 1 of 10 Page 2 of 10 Contents 1. Introduction... 4 2. Quality Statement ISO 9001:2015... 4 3.
More informationRoles & Responsibilities Company Officers & Chief Executive
Roles & Responsibilities Company Officers & Chief Executive Chair of the Board The Chair has a vital leadership, strategic and management function in British Orienteering. The appointment of the Chair
More informationGENE EXPRESSION REAGENTS MARKETS (SAMPLE COPY, NOT FOR RESALE)
TriMark Publications April 2007 Volume: TMRGER07-0401 GENE EXPRESSION REAGENTS MARKETS (SAMPLE COPY, NOT FOR RESALE) Trends, Industry Participants, Product Overviews and Market Drivers TABLE OF CONTENTS
More informationQUESTIONNAIRE FOR COMPETENT AUTHORITIES TO BE USED FOR ASSESSMENT, REASSESSMENT AND SELF- EVALUATION
PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PS/W 1/2011 2 Annexes 22 July 2011 QUESTIONNAIRE FOR COMPETENT AUTHORITIES TO BE USED FOR ASSESSMENT, REASSESSMENT AND SELF- EVALUATION PIC/S 2011 Reproduction
More informationProcess validation in medical devices
Process validation in medical devices Fulfil requirements with expert regulatory guidance 1TÜV SÜD Contents INTRODUCTION 4 VALIDATION PLANNING 5 INSTALLATION QUALIFICATION 7 OPERATIONAL QUALIFICATION 9
More informationEric W. Abelquist, Ph.D., CHP President, Health Physics Society. August 2017
Careers in Health Physics Eric W. Abelquist, Ph.D., CHP President, Health Physics Society August 2017 What Is Health Physics? Study of radiation and its effects on people Multidisciplinary Physics Biology
More informationOutsource or in-house? The evolving role of analytical services in pharmaceutical manufacturing
Outsource or in-house? The evolving role of analytical services in pharmaceutical manufacturing By Impact Analytical Introduction About Impact Analytical Impact Analytical is a contract analytical testing
More informationMeeting of the Board of Dire 2010 in the boardroom. Audit committee annual report April March 2017
Meeting of the Board of Dire 2010 in the boardroom Audit committee annual report April 2016 - March 2017 Audit Committee Annual Report April 2016 March 2017 1. Introduction The purpose of this report is
More informationLead Employer Flexible Working Policy. Trust Policy
Lead Employer Flexible Working Policy Type of Document Code: Policy Sponsor Lead Executive Recommended by: Trust Policy Deputy Director of Human Resources Director of Human Resources Date Recommended:
More informationA new challenge for online food retailers in Turkey. A Leatherhead Food Research white paper. Gokay Sen
A new challenge for online food retailers in Turkey A Leatherhead Food Research white paper 54 Gokay Sen A new challenge for online food retailers in Turkey At the beginning of 2017, Turkey s Ministry
More informationTextvergleich. Verglichene Dokumente MEDIA3917.pdf. ICH_Q10_Step4.pdf
Textvergleich Verglichene Dokumente MEDIA3917.pdf ICH_Q10_Step4.pdf Übersicht 2270 Wort/Wörter hinzugefügt 1338 Wort/Wörter gelöscht 3558 Wort/Wörter übereinstimmend 157 Block/Blöcke übereinstimmend Blättern
More informationCHALLENGES OF GLOBAL CLINICAL TRIAL SUPPLY SOURCING SOME SPECIFICS FOR EMERGING MARKETS
Clinical Trial Supply 28 th 29 th October 2014 Princeton, NJ - USA CHALLENGES OF GLOBAL CLINICAL TRIAL SUPPLY SOURCING SOME SPECIFICS FOR EMERGING MARKETS 1 Agenda The challenges associated with various
More informationSwiss Multiple Sclerosis Society Rules of Procedure for the Scientific Advisory Board
Swiss Multiple Sclerosis Society Rules of Procedure for the Scientific Advisory Board Based on Art. 8 of the Statutes, the following Rules of Procedure for the Scientific Advisory Board (SAB) are adopted:
More informationCase Study: Quintiles Transnational Corporation
: Quintiles Transnational Corporation Project Overview The Project covers the development and implementation of the custom application allowing for biometric identification by fingerprints of medical workers
More informationGift Aid and Compliance Manager. MS National Centre, London. Head of Supporter Engagement
Job Title: Location: Reports to: Gift Aid and Compliance Manager MS National Centre, London Head of Supporter Engagement Introduction to MS Society The MS Society is the UK s leading MS charity. Since
More informationIBBL: Introduction to Biobanks and their services
IBBL: Introduction to Biobanks and their services HighTech meets Health, Oss (NL), 15 th June 2017 Monica Marchese, PhD Biomarker Validation Scientist AN ACCREDITED & CERTIFIED BIOBANK INFRASTRUCTURE FOR
More informationCLOSING DATE: 27 TH SEPTEMBER 2013
Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn POSITION: EXECUTIVE DIRECTOR, IRISH INSTITUTE OF PHARMACY CLOSING DATE: 27 TH SEPTEMBER 2013 EDUCATIONAL EXCELLENCE IN SURGERY MEDICINE
More informationMEDICAL DEVICE. Technical file.
MEDICAL DEVICE Technical file www.icaro-research.eu ICARO MDTF v1.0 1 Mar 2016 1. Do you plan to launch your medical device in Europe? If you re reading this, chances are good that you re considering introducing
More informationEUROPEAN INDUSTRIAL PHARMACISTS GROUP. Guidance on CPD for QUALIFIED PERSONS
EUROPEAN INDUSTRIAL PHARMACISTS GROUP Guidance on CPD for QUALIFIED PERSONS EIPG Guidance on CPD for QP Continuing Professional Development for Qualified Persons, Technical Directors and other Responsible
More informationCould you help lead the NHS in your area?
Could you help lead the NHS in your area? Non-executive Director Candidate information pack Reference: S1666 We value and promote diversity and are committed to equality of opportunity for all and appointments
More informationThe new EU Regulations on medical devices and first steps of their implementation
The new EU Regulations on medical devices and first steps of their implementation TOPRA Annual Medical Devices Symposium 2017 London, 3 October 2017 Erik HANSSON Deputy Head of Unit Health Technology and
More informationCOUNTRY OVERVIEW: THAILAND. August 2012 SPECIAL REPRINT. By Rarana Phanudulkitti
August 2012 SPECIAL REPRINT COUNTRY OVERVIEW: THAILAND By Rarana Phanudulkitti Reproduced with the kind permission of Global Regulatory Press from the Journal of Medical Device Regulation, 2012, 9(3),
More informationEstablishment of Clinical Trial Infrastructure
Taiwan s Strategy in the Establishment of Clinical Trial Infrastructure Chei-Hsiang Chen, Ph. D. Director, Biotechnology and Pharmaceutical Industries Program Office, Ministry of Economic Affairs, Taiwan
More informationQCTO Assessment Quality Partner (AQP) Criteria and Guidelines
QCTO Assessment Quality Partner (AQP) Criteria and Guidelines Approved 20 February 2013 QCTO AQP 001/13: Approved QCTO AQP Criteria and Guidelines Page 1 Table of Contents List of acronyms 3 Glossary.
More informationThe Annual Audit Letter for Avon and Wiltshire Mental Health Partnership NHS Trust
The Annual Audit Letter for Avon and Wiltshire Mental Health Partnership NHS Trust Year ending 31 March 2016 29 June 2016 Barrie Morris Engagement Lead T 0117 305 7708 E Barrie.Morris@uk.gt.com Kevin Henderson
More informationMedical Device Registration in China
www.cirs-md.com IVD Medical Device Registration in China Your Local Regulatory Affairs Staff-CIRS CIRS assist you Overseas Medical Devices In Vitro Diagnostic reagent Market access CFDA Registration Pre-market
More informationHOW TO APPLY FOR MEDICAL DEVICE REGISTRATION UNDER MEDICAL DEVICE ACT 2012 (ACT 737)
MDA/GL No 1: July 2013 Guidelines for implementation of medical device regulatory system HOW TO APPLY FOR MEDICAL DEVICE REGISTRATION UNDER MEDICAL DEVICE ACT 2012 (ACT 737) [Appendix 4 Schedule 3 Medical
More information