Medical Device Innovation Consortium Device Product Quality Metrics

Size: px
Start display at page:

Download "Medical Device Innovation Consortium Device Product Quality Metrics"

Transcription

1 Medical Device Innovation Consortium Device Product Quality Metrics September 8,

2 Presentation Outline Topics to be Addressed Team Members Timeline and Process Pre-Production Metric Development Production Metric Development Post-Production Metric Development Pilot Study Design and Next Steps 2

3 Team Members * Participated in initial work First Last Title Company Paul Andreassi * Vice President of Quality & Regulatory Fisher & Paykel Healthcare Pat Baird * Director, Engineering Baxter Healthcare Anupam Bedi * Director of Quality AtriCure Pankit Bhalodia Director PwC KB Bheda Senior Associate PwC Steve Binion Director Regulatory Affairs/Corporate Clinical Development Robin Blankenbaker Divisional Quality Operations Leader W.L. Gore & Associates Gina Brackett * Compliance Officer FDA Patrick Caines * Dir, Quality & Global post market surveillance Baxter Healthcare Kara Carter Senior Director, QA Operations Abbott Vascular Division Vizma Carver Founder and CEO BD Carver Global Health Group Ryan Eavey Senior Manager, Quality Systems Stryker 3

4 Team Members * Participated in initial work First Last Title Company Joanna Engelke Senior Vice President Global Quality Boston Scientific Chris Hoag Director of Global CAPA and Quality esystems Stryker Frank Johnston Corporate Director, Regulatory Compliance BD Jonathan Lee Senior Associate PwC Bill MacFarland Director, Division of Manufacturing Quality FDA Kristin McNamara * Senior Advisor FDA Rhonda Mecl * Supervisory CSO FDA Brian Motter * VP Quality and Compliance, Diabetes J&J MD&D Ravi Nabar Sr. Director Supplier Quality Management Philips Steven Niedelman * Lead Quality Systems and Compliance Consultant King & Spalding LLP Pete Palermo * VP Quality Assurance CR Bard Marla Phillips * Director Xavier University 4

5 Team Members * Participated in initial work First Last Title Company Greg Pierce President and Founder Engisystems Susan Rolih * Executive Vice President, Regulatory and Quality Systems Meridian Bioscience, Inc. Joe Sapiente * VP Global Quality Operations Covidien Benjamin Smith Vice President, Global Quality System & Compliance Biomerieux Isabel Tejero * Quality System Workgroup Lead CSO FDA Shelley Turcotte WW Director Quality Information Systems DePuy Synthes Sam Venugopal Partner PwC Marta Villarraga Principal Biomedical Engineering Exponent Monica Wilkins * Divisional Vice President of Quality and Business Support Abbott 5

6 Purpose and Goals Purpose: To support the Case for Quality by increasing the assurance of product quality Goals: 1. Identify, pilot and publicize predictive product quality metrics 2. Improve assessment of the evolving state of product quality 3. Enable FDA risk-based resource allocation decisions 4. Provide Payor visibility to product quality risk

7 Power and Benefits of Measures Linkage to Total Product Lifecycle Linkage to Critical Quality Systems Patient Safety Linkage to Critical Requirements Design Robustness Process Reliability Quality System Robustness Failure Costs

8 Timeline and Process Sept Oct Mar 2015 Mar May 2015 Jun Sept 2015 Oct Jun 2016 Beyond Jun 2016 Kick-off Critical Systems Gold/Silver Activities C&E Matrix Finalization of Measures Selection of Top 3 Measures Conversion of Measures into Metrics Pilot Pilot Analysis Finalization Competency Initiative Advanced Analytics Maturity Model FDA Risk Assessment Industry Risk Assessment

9 How we Chose the Top 3 Measures Enterprise-Wide Continual Improvement Post- Production Pre-Production Transfer Production R&D Continual Improvement & Risk Mgmt. Production Continual Improvement & Risk Mgmt.

10 Conversion of Top 4 Measures Process Steps 1. Reviewed the Pre-Work Packet for the Measure to be discussed 2. Aligned on Common Terminology 3. Revised/Improved Wording of Measure if Needed 4. Discussed Metric Ideas Provided 5. Proposed Final Metric(s) 6. Repeated the Process for the remaining 3 measures 10

11 Pre-Production Identification of design and process elements that eliminate, reduce, and prevent design failures throughout the product lifecycle (including transfer, production, and post-production failures) Metric: Design Robustness Metric Total # of product design changes driven by quality issues / total # of product designs *(factor for age) Product agnostic Measured by Design Center / Product Family / Business Unit (as determined by the company, for their design control process) 11

12 Pre-Production Evidence that customer input, both internal and external, is actively solicited, documented, and assessed, at all stages of design project. This includes early feedback from controlled market release (pilot) and post-launch VOC data from related products. It was determined that this would be better suited as a guidance than a metric Deemed out of scope for the work of this team 12

13 Production Tracking and trending of right first time data (i.e. product built with no non-conformance/rework/failed inspections). Metric: # of units mfg. without Non-conformances / # of units attempted excludes planned rework and set up scrap units can be changed out with lots if appropriate Timeframe: Monthly Metrics will be measured by site and if possible, by product Metrics can also be measured by value stream (i.e. category of products / work centers) and by site Track and trend on a rolling basis 13

14 Post-Production Trending/analyzing key post market surveillance data (e.g., complaints, FCAs, PHOs, HHEs) for overall QMS performance and feed into holistic QMS scorecard. Metric: Complaints * (0.20) + Service Records * (0.10) + Installation Failures * (0.10) + MDRs * (0.10) + Recalls (units) * (0.10) + Recalls (total) * (0.10) + Design Changes * (0.20) + Nonconformances (0.10) 14

15 Post-Production Index Metric Complaints: Complaints for the product / units sold (for the product) Service Records: Records per product / # of total units in service (for the period) Installation failures: # of installation failures/ total # of installations (for the period) MDRs MDRs for the product / units sold (for the product) Recalls # of units recalled / # of units sold (for the period) worldwide (if applicable) Recalls - # of recalls (for the period) worldwide # of product Design Changes Count for the period Non-conformances - total # of NCs / # of units (produced, released, sold, etc.) 15

16 Pilot Study Design Each company chooses products/work centers to include in the study that have differing levels of complexity and success The study will only be retrospective, and participants have 6 months to complete the work Goal: demonstrate that the metrics are sensitive enough to differentiate between varying levels of product quality Companies will not be compared to each other Pilot Companies to date: Biomerieux, J&J Diabetes, Stryker, WL Gore 16

17 Immediate Next Steps Virtual meeting on September 10 th Establish NDA with pilot companies Pilot refinement with company input Refinement of metrics tailored to company-specific business Launch of retrospective pilot October - March 17

18 Pulling it All Together AdvaMed Best Practices FDA/Xavier MDIC Metrics MDIC Maturity Model MDIC Competency MDIC Advanced Analytics Risk Assessment

MDIC Case for Quality Forum Quality System Maturity Model Update

MDIC Case for Quality Forum Quality System Maturity Model Update Case for Quality Forum Quality System Maturity Model Update George Serafin Deloitte & Touche LLP 1 Quality System Maturity Model Project Team Team Members Company Pat Baird Baxter Jodie Bastian Stryker

More information

Addressing Risk in Partner / Contractor Selection and Onboarding. Michael Davidson VP Quality Systems and Compliance March 2014

Addressing Risk in Partner / Contractor Selection and Onboarding. Michael Davidson VP Quality Systems and Compliance March 2014 Addressing Risk in Partner / Contractor Selection and Onboarding Michael Davidson VP Quality Systems and Compliance March 2014 Industry Trends Pfizer Overview Pfizer s Approach Risk Based Robust Due Diligence

More information

Setting Up A Complaint Handling System. Presented by Sue Jacobs Principal Consultant, QMS Consulting, Inc. Complaint Systems

Setting Up A Complaint Handling System. Presented by Sue Jacobs Principal Consultant, QMS Consulting, Inc. Complaint Systems Setting Up A Complaint Handling System Presented by Sue Jacobs Principal Consultant, QMS Consulting, Inc. January 2008 ~ Orlando, Florida QMS Consulting, Inc. 2008 1 Complaint Systems Written Procedures

More information

ICH Q10 - Pharmaceutical Quality System

ICH Q10 - Pharmaceutical Quality System WCC PDA Dinner Meeting Jan 2012 ICH Q10 - Pharmaceutical Quality System Neil Wilkinson NSF-DBA www.nsf-dba.com ICHQ10.1 WCC PDA Dinner Meeting Jan 2012 Your Presenter Partner at NSF-DBA USA Training, Consultancy,

More information

ORACLE AGILE PLM FOR THE MEDICAL DEVICE INDUSTRY

ORACLE AGILE PLM FOR THE MEDICAL DEVICE INDUSTRY ORACLE AGILE PLM FOR THE MEDICAL DEVICE INDUSTRY Enterprise PLM is a strategic approach to managing the lifecycle of a product throughout its full value chain: from initial requirements gathering through

More information

How to Use the Design Process to Manage Risk: Elements of Design Controls and Why It Matters

How to Use the Design Process to Manage Risk: Elements of Design Controls and Why It Matters environmental failure analysis & prevention health technology development How to Use the Design Process to Manage Risk: Elements of Design Controls and Why It Matters Kevin L. Ong, Ph.D., P.E. Managing

More information

TrackWise - Quality Management System

TrackWise - Quality Management System TrackWise - Quality Management System Focus area: Electronic Management of CAPA Systems in the Regulated Industry May 11, 2007 Yaniv Vardi VP, Operations Sparta Systems Europe, Ltd. Agenda Sparta Systems

More information

Abbott Global Purchasing Services. Supplier Performance Program

Abbott Global Purchasing Services. Supplier Performance Program Abbott Global Purchasing Services Supplier Performance Program SUPPLIER PERFORMANCE PROGRAM Without question, supplier relationships have a significant impact on Abbott s corporate success. Abbott Global

More information

Aligning Quality Management Processes to Compliance Goals

Aligning Quality Management Processes to Compliance Goals Aligning Quality Management Processes to Compliance Goals MetricStream.com Smart Consulting Group Joint Webinar February 23 rd 2012 Nigel J. Smart, Ph.D. Smart Consulting Group 20 E. Market Street West

More information

QMS Manual 2350 Helen Street, N. St. Paul, MN 55109 Page 1 of 5. Quality Management System Manual

QMS Manual 2350 Helen Street, N. St. Paul, MN 55109 Page 1 of 5. Quality Management System Manual 2350 Helen Street, N. St. Paul, MN 55109 Page 1 of 5 AETRIUM Quality Management System Manual 2350 Helen Street, N. St. Paul, MN 55109 Page 2 of 5 Introduction It is a strategic decision by Aetrium management

More information

ROOT CAUSE ANALYSIS. Prevent Non-Compliance and Achieve Successful Root Cause Analyses and CAPA Systems Implementation from Clinical to Post-Market

ROOT CAUSE ANALYSIS. Prevent Non-Compliance and Achieve Successful Root Cause Analyses and CAPA Systems Implementation from Clinical to Post-Market 5th SIGNAL DETECTION, ROOT CAUSE ANALYSIS & January 22-23, 2015 Key Bridge Marriott Arlington, VA Prevent Non-Compliance and Achieve Successful Root Cause Analyses and CAPA Systems Implementation from

More information

2014 Annual FDA Medical Device Quality System Data. FDA Form 483 Observations and Warning Letter Citations

2014 Annual FDA Medical Device Quality System Data. FDA Form 483 Observations and Warning Letter Citations 2014 Annual FDA Medical Device Quality System Data FDA Form 483 Observations and Warning Letter Citations Why is FDA making these data available? In support of the FDA s Transparency and Case for Quality

More information

Placing Quality at the Core of Your Business Processes

Placing Quality at the Core of Your Business Processes Trusted Advisors to Healthcare and Life Science Executives Presented by Daniel R. Matlis Placing Quality at the Core of Your Business Processes Copyright 2009 Axendia, Inc. 1 1 Presented at NetApp Pharma

More information

Compliance & Internal Audit Collaboration

Compliance & Internal Audit Collaboration www.pwc.com Compliance & Internal Collaboration Developing a compliance third line of October 2015 The Society of Corporate Compliance & Ethics 14 th Annual Compliance & Ethics Institute Conference Introductions

More information

Closed Loop Quality Management: Integrating PLM and Quality Management

Closed Loop Quality Management: Integrating PLM and Quality Management Integrating PLM and Quality Management In recent Aberdeen research of over 500 manufacturers it was shown that 100% of Best-in-Class manufacturers having both a Quality Management solution and Product

More information

Identification of Medicinal Products (IDMP) What is necessary in order to be compliant in 2016 and beyond?

Identification of Medicinal Products (IDMP) What is necessary in order to be compliant in 2016 and beyond? Identification of Medicinal Products (IDMP) What is necessary in order to be compliant in 2016 and beyond? February 2015 Audit. Tax. Consulting. Corporate Finance. New ISO standards have been developed

More information

Using Training Data to Drive Up Quality Metrics SURVEY OF QUALITY ASSURANCE EXECUTIVES

Using Training Data to Drive Up Quality Metrics SURVEY OF QUALITY ASSURANCE EXECUTIVES Using Training Data to Drive Up Quality Metrics SURVEY OF QUALITY ASSURANCE EXECUTIVES SURVEY OF QUALITY ASSURANCE EXECUTIVES The FDA s Push for Data and Metrics For the US FDA investigator, the single

More information

Attention: 2015 Edition EHR Standards and Certification Criteria, Proposed Rule; 79 Federal Register Notice 10880 (Feb. 26, 2014)

Attention: 2015 Edition EHR Standards and Certification Criteria, Proposed Rule; 79 Federal Register Notice 10880 (Feb. 26, 2014) April 21, 2014 Department of Health and Human Services Office of the National Coordinator for Health Information Technology Hubert H. Humphrey Building Suite 729D 2000 Independence Ave., SW Washington,

More information

Third-Party Cybersecurity and Data Loss Prevention

Third-Party Cybersecurity and Data Loss Prevention Third-Party Cybersecurity and Data Loss Prevention SESSION ID: DSP-W04A Brad Keller Sr. Vice President Santa Fe Group Jonathan Dambrot, CISSP CEO, Co-Founder Prevalent Networks 3rd Party Risk Management

More information

Empowering the Quality and Regulatory Compliance Functions

Empowering the Quality and Regulatory Compliance Functions Empowering the Quality and Regulatory Compliance Functions Management must take steps to ensure that regulatory and quality compliance is everyone s responsibility. By: J. Glenn George, Kenneth Imler,

More information

Appropriate Use of Agile in Medical Device Software Development

Appropriate Use of Agile in Medical Device Software Development Appropriate Use of Agile in Medical Device Software Development Presented May 18, 2011 Software Division & Biomedical Division Joint Session David Walker Member, AAMI Agile TIR Working Group Agenda Overview

More information

Using the Cost of Poor Quality to Drive Process Improvement

Using the Cost of Poor Quality to Drive Process Improvement Using the Cost of Poor Quality to Drive Process Improvement March, 2006 Presented by: Dan Olivier, Certified Software Solutions, Inc. (dolivier@certifiedsoftware.com) Javad Seyedzadeh, Bayer Healthcare

More information

GRAPHIC CONTROLS Quality Management Systems Manual

GRAPHIC CONTROLS Quality Management Systems Manual GRAPHIC CONTROLS Quality Management Systems Manual BUFFALO OPERATIONS - PROCEDURE This Replaces Title: QUALITY MANUAL Number: 1-42-01 Rev AV 1-42-01 Rev AU Page: ii of 27 ii of 27 Date: 8/12/15 7/01/15

More information

Today s Best Practices in Global Product Surveillance Systems

Today s Best Practices in Global Product Surveillance Systems Today s Best Practices in Global Product Surveillance Systems Presented by: Nancy Singer Compliance-Alliance Richard J. DeRisio, M.S. Kinetic Concepts, Inc. 1 Management of Complaint and Service Experience

More information

Standard of measurement by which efficiency, performance, progress, or quality of a plan, process, or product can be assessed 1.

Standard of measurement by which efficiency, performance, progress, or quality of a plan, process, or product can be assessed 1. Meaningful Metrics What is a Metric? Standard of measurement by which efficiency, performance, progress, or quality of a plan, process, or product can be assessed 1. A quality metric is a measurement of

More information

Data Governance: Measure Twice, Cut Once. April 14, 2015

Data Governance: Measure Twice, Cut Once. April 14, 2015 Data Governance: Measure Twice, Cut Once April 14, 2015 Dr. Stephen Morgan, SVP & CMIO, Carilion Clinic Randy L. Thomas, FHIMSS, Associate Partner, Encore, A Quintiles Company DISCLAIMER: The views and

More information

David Wohler. Vice President of Global Sourcing and Real Estate - Covidien

David Wohler. Vice President of Global Sourcing and Real Estate - Covidien David Wohler Vice President of Global Sourcing and Real Estate - Covidien Covidien August 2, 2011 Driving Value from a Supplier Relationship Management Program David Wohler, VP Global Sourcing The Expectations

More information

Survey Results on The Structure of Medical Device Firms Quality/Regulatory/Compliance Functions

Survey Results on The Structure of Medical Device Firms Quality/Regulatory/Compliance Functions Survey Results on The Structure of Medical Device Firms Quality/Regulatory/Compliance Functions Nancy Singer Compliance-Alliance LLC www.compliance-alliance.com nancy@compliance-alliance.com Survey Results

More information

Guidance for Industry. Q10 Pharmaceutical Quality System

Guidance for Industry. Q10 Pharmaceutical Quality System Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation

More information

7+ years in Human Capital Management Consulting. Industries: Telecom; Media; Automotive; Energy; Airline; Banking

7+ years in Human Capital Management Consulting. Industries: Telecom; Media; Automotive; Energy; Airline; Banking 2 years at Cox Enterprises 7+ years in Human Capital Management Consulting Industries: Telecom; Media; Automotive; Energy; Airline; Banking Previous Employers: Wipro Consulting Services, Buck Consultants,

More information

ICH Public Meeting. Joseph C. Famulare. October 2, 2006. Acting Deputy Director Office of Compliance CDER / FDA Office of Compliance

ICH Public Meeting. Joseph C. Famulare. October 2, 2006. Acting Deputy Director Office of Compliance CDER / FDA Office of Compliance ICH Public Meeting October 2, 2006 Joseph C. Famulare Acting Deputy Director Office of Compliance CDER / FDA Office of Compliance The Current State of Pharmaceutical Manufacturing Inability to predict

More information

Design Controls: Are They Worth the Effort?

Design Controls: Are They Worth the Effort? Design Controls: Are They Worth the Effort? Compliance-Alliance conducted a survey to measure the effects of FDA s design control regulation on the industry. Most respondents believe the controls have

More information

Supply Quality Assurance

Supply Quality Assurance Supply Quality Assurance Electric / Gas T&D, Hydro, Solar and Fossil Fuel Power Generation 2014 Supplier Conference Jim Adamson Director, Supplier Quality Assurance Engaging With Suppliers How Supplier

More information

Evolving the CPA Profession s Peer Review Program for the Future

Evolving the CPA Profession s Peer Review Program for the Future Evolving the CPA Profession s Peer Review Program for the Future A provocative vision of what practice monitoring could become REIMAGINE FUTURE INSPECTION PRACTICE MONITORING PEER REVIEW OVERSIGHT FEEDBACK

More information

Introducing Agility into a Phase Gate Process

Introducing Agility into a Phase Gate Process B E S T P R A C T I C E S W H I T E P A P E R Introducing Agility into a Phase Gate Process Jenny Stuart, Vice President of Consulting, Construx Software Version 1.1, June 2011 Contributors Earl Beede,

More information

Quality Risk Management - The Medical Device Experience. Niamh Nolan Principal Design Assurance Engineer Boston Scientific

Quality Risk Management - The Medical Device Experience. Niamh Nolan Principal Design Assurance Engineer Boston Scientific Quality Risk Management - The Medical Device Experience Niamh Nolan Principal Design Assurance Engineer Boston Scientific Agenda Intent of Risk Management (RM) and Associated Regulations Overview of RM

More information

ICH Q10 Pharmaceutical Quality System (PQS)

ICH Q10 Pharmaceutical Quality System (PQS) ICH Q10 Pharmaceutical Quality System (PQS) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Q10 PQS Guideline Background Objectives

More information

Partnership for Food Protection (PFP) Strategic Plan FY 2015 through FY 2020

Partnership for Food Protection (PFP) Strategic Plan FY 2015 through FY 2020 Partnership for Food Protection (PFP) Strategic Plan FY 2015 through FY 2020 Page 1 of 14 November 19, 2014 Dear Valued Partner: The Partnership for Food Protection (PFP) was established in 2009 to work

More information

Health Research Institute. Major shift ahead in how FDA regulates drug quality

Health Research Institute. Major shift ahead in how FDA regulates drug quality Health Research Institute Spotlight February 2016 Major shift ahead in how FDA regulates drug quality Parts of the pharmaceutical industry continue to struggle with drug quality. A major shift in the way

More information

MEDICAL DEVICE & DIAGNOSTICS

MEDICAL DEVICE & DIAGNOSTICS to Guide Strategic Medical Device and Introduction Medical device and diagnostic makers face myriad challenges when developing a new product, including working within resource and financial constraints,

More information

True Product Lifecycle Management Begins When Design Ends. strategy may dictate involvement in all or just a few implemented according to design

True Product Lifecycle Management Begins When Design Ends. strategy may dictate involvement in all or just a few implemented according to design ARC PROFILE By Greg Gorbach April 2006 True Product Lifecycle Management Begins When Design Ends Consider that the end-to-end lifecycle of a product begins with the first spark of innovation and ends when

More information

Sage ERP I White Paper

Sage ERP I White Paper The Premier Provider of Effective Business Software Solutions National Presence, Local Touch 1.800.4.BLYTHE www.blytheco.com I White Paper Profitable Innovation Medical Device Business Model for Growth

More information

Training and Coaching

Training and Coaching Project Profiles: Agile Implementation Services Financial Services Agile Consulting Services Review/Assessment and Coaching Our client previously built a Software Factory of 30+ teams to build and support

More information

Utilizing Enterprise Quality Management to Optimize the Supply Chain and Gain Greater Visibility Into Processes Across the Business Ecosystem

Utilizing Enterprise Quality Management to Optimize the Supply Chain and Gain Greater Visibility Into Processes Across the Business Ecosystem Utilizing Enterprise Quality Management to Optimize the Supply Chain and Gain Greater Visibility Into Processes Across the Business Ecosystem Using Supplier Quality Management Before We Begin If you experience

More information

Software Development for Medical Devices

Software Development for Medical Devices Overcoming the Challenges of Compliance, Quality and Cost An MKS White Paper Introduction Software is fast becoming the differentiator for manufacturers of medical devices. The rewards available from software

More information

Release of the Draft Cybersecurity Procurement Language for Energy Delivery Systems

Release of the Draft Cybersecurity Procurement Language for Energy Delivery Systems Release of the Draft Cybersecurity Procurement Language for Energy Delivery Systems Energy Sector Control Systems Working Group Supporting the Electricity Sector Coordinating Council, Oil & Natural Gas

More information

How To Transform It Risk Management

How To Transform It Risk Management The transformation of IT Risk Management kpmg.com The transformation of IT Risk Management The role of IT Risk Management Scope of IT risk management Examples of IT risk areas of focus How KPMG can help

More information

WHO S GOT THE BALL? THE CHALLENGE OF ALIGNMENT

WHO S GOT THE BALL? THE CHALLENGE OF ALIGNMENT 1 WHO S GOT THE BALL? THE CHALLENGE OF ALIGNMENT Roger E Olson ASQ 0701 October 30, 2015 2 On Change There is nothing more difficult to take in hand, more perilous to conduct, or more uncertain in its

More information

Getting a Handle on Complaints

Getting a Handle on Complaints Getting a Handle on Complaints Industry continues to be deficient in complaint-handling procedures despite FDA having made those a priority for a long time. A new survey aims to help change that. By: Erik

More information

Executive insights. Healthcare Reform Shifts Hospital Priorities, Creates New Opportunities for MedTech Companies. Recalibrating Purchasing Criteria

Executive insights. Healthcare Reform Shifts Hospital Priorities, Creates New Opportunities for MedTech Companies. Recalibrating Purchasing Criteria Volume XIII, Issue 4 Healthcare Reform Shifts Hospital Priorities, Creates New Opportunities for MedTech Companies The winds of change from healthcare insurance reform are causing hospital executives to

More information

Later-Stage Development: Ensuring Compliance During. for a Competitive Advantage Webinar Series

Later-Stage Development: Ensuring Compliance During. for a Competitive Advantage Webinar Series Part II: Later-Stage Development: Ensuring Compliance During Clinical i l Trials Process Driven Compliance for a Competitive Advantage Webinar Series 29 September 2010 Process Driven Compliance Webinar

More information

Oracle s Agile Enterprise. for the Product Value Chain. Addressing the Challenges of Product-Oriented Businesses

Oracle s Agile Enterprise. for the Product Value Chain. Addressing the Challenges of Product-Oriented Businesses Oracle s Agile Enterprise Product Lifecycle Management for the Product Value Chain Addressing the Challenges of Product-Oriented Businesses Enterprise Product Lifecycle Management as a Strategic Initiative

More information

Using ROI to Measure the Results of Business Process Improvement Initiatives

Using ROI to Measure the Results of Business Process Improvement Initiatives Using ROI to Measure the Results of Business Process Improvement Initiatives Overview Given today s economy and the need to do more with reduced resources, budgets, etc., organizations are looking to improve

More information

PHARMACEUTICAL QUALITY SYSTEM Q10

PHARMACEUTICAL QUALITY SYSTEM Q10 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE PHARMACEUTICAL QUALITY SYSTEM Q10 Current Step

More information

Gap Analysis of the Change Control Process The History of a Transformed Change Control System

Gap Analysis of the Change Control Process The History of a Transformed Change Control System Gap Analysis of the Change Control Process The History of a Transformed Change Control System Juan Alcazar Quality Systems Carolina, PR Content Introduction Gap Analysis Phases to perform a Gap Analysis

More information

ISO 13485:201x What is in the new standard?

ISO 13485:201x What is in the new standard? ISO 13485:201x What is in the new standard? Eric Finegan, Quality Mgr, BTE Technologies, Inc. 2015-09-10 1 Presentation Slides This slide deck is the presentation performed on 2015-09-10. A more detailed

More information

Senior Management Engagement in the Quality Management System. Tom Kartachak VP Quality and Compliance Parsons Government Services Session C2

Senior Management Engagement in the Quality Management System. Tom Kartachak VP Quality and Compliance Parsons Government Services Session C2 Senior Management Engagement in the Quality Management System Tom Kartachak VP Quality and Compliance Parsons Government Services Session C2 Purpose Review Parsons Government Services (PGS) Senior Management

More information

MDIC Modeling and Simulation Summit

MDIC Modeling and Simulation Summit 1 Our Members Abbott Vascular, Abiomed, AdvaMed, ANSYS, AptivSolutions, B. Braun Medical, BD Becton, Dickinson & Co., Biomet, Inc., Boston Scientific, Cardiovascul`ar Research Foundation Skirball Center,

More information

Safety Management Program

Safety Management Program Corrective Action Plan (CAP) Safety Management Program Submitted by TransCanada PipeLines Limited and its National Energy Board Regulated Subsidiaries to address non-compliant findings in the National

More information

1,000 ajobse]dd. Accenture 2013. All rights reserved. Commercial in confidence. Subject to contract. Oct 2012 1

1,000 ajobse]dd. Accenture 2013. All rights reserved. Commercial in confidence. Subject to contract. Oct 2012 1 1,000 ajobse]dd Oct 2012 1 1. Executive Summary The Department of Social Protection (DSP) is responsible for the provision of income supports and employment services in Ireland and process around 20billion

More information

Compliance by Design (CbD)

Compliance by Design (CbD) Compliance by Design (CbD) Building an Effective & Sustainable Compliance Program Dale Skivington Executive Director, Global Compliance and Privacy Dell today Technology has always been about enabling

More information

Michael Kickuth and Thomas Friedli

Michael Kickuth and Thomas Friedli IV Operational Excellence in the Pharmaceutical Industry: Case Studies from the Field In this chapter we want to give some guidance for people responsible for implementing Operational Excellence programs.

More information

Performance Measurement

Performance Measurement Performance Measurement Introduction Performance measurement is a fundamental building block of TQM and a tal quality organisation. Hisrically, organisations have always measured performance in some way

More information

Midwest Big Data Hub Le#ers of Intent for NSF 16-510

Midwest Big Data Hub Le#ers of Intent for NSF 16-510 Midwest Big Data Hub Le#ers of Intent for NSF 16-510 Edward Seidel Director, NCSA Founder Prof. of Physics, Prof of Astronomy On behalf of the Midwest Big Data Hub Brian Athey Sarah Nusser Beth Plale Josh

More information

Linking Your Business Strategy to

Linking Your Business Strategy to Linking Your Business Strategy to Your Technology Strategy Smart man learns from his mistakes Wise man learns from smart man s mistakes Chinese proverb Webinar Survey What specifically do you want to learn

More information

Quality Management System Certification. Understanding Quality Management System (QMS) certification

Quality Management System Certification. Understanding Quality Management System (QMS) certification Quality Management System Certification Understanding Quality Management System (QMS) certification The medical device manufacturing sector is one of the most regulated sectors in which significant quality

More information

Business Intelligence and Analytics: Leveraging Information for Value Creation and Competitive Advantage

Business Intelligence and Analytics: Leveraging Information for Value Creation and Competitive Advantage PRACTICES REPORT BEST PRACTICES SURVEY: AGGREGATE FINDINGS REPORT Business Intelligence and Analytics: Leveraging Information for Value Creation and Competitive Advantage April 2007 Table of Contents Program

More information

Solution Architecture Overview. Submission Management. 2015 The Value Enablement Group, LLC. All rights reserved.

Solution Architecture Overview. Submission Management. 2015 The Value Enablement Group, LLC. All rights reserved. Solution Architecture Overview Submission Management 1 Submission Management Overview Sources of Record MDM Manually Captured Lifecycle Events PLM Repository Data Domain Objects supporting Submission Process

More information

ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION

ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 038-1 26 March 2012 AIDE-MEMOIRE ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION PIC/S March 2012 Reproduction

More information

ICH Q 10 Pharmaceutical Quality System PQS DIA China Annual Meeting, May 2010

ICH Q 10 Pharmaceutical Quality System PQS DIA China Annual Meeting, May 2010 ICH Q 10 Pharmaceutical Quality System PQS DIA China Annual Meeting, May 2010 Joseph C. Famulare Head of External Relations and Collaboration Pharma Global Technical Operations Global Quality, F. Hoffmann-La

More information

FINAL DOCUMENT. Global Harmonization Task Force

FINAL DOCUMENT. Global Harmonization Task Force FINAL DOCUMENT Global Harmonization Task Force Title: Quality management system Medical Devices Guidance on corrective action and preventive action and related QMS processes Authoring Group: Study Group

More information

QUALITY ASSURANCE GUIDE FOR GREEN BUILDING RATING TOOLS

QUALITY ASSURANCE GUIDE FOR GREEN BUILDING RATING TOOLS World Green Building Council Rating Tools Task Group: QUALITY ASSURANCE GUIDE FOR GREEN BUILDING RATING TOOLS Version 1.0 _ 2013 /(DRAFT_01 /Sept_13) INTRODUCTION This guide has been developed as a part

More information

WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE

WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE White paper produced by Maetrics For more information, please contact global sales +1 610 458 9312 +1 877 623 8742 globalsales@maetrics.com

More information

2012 HIPAA Privacy and Security Audits

2012 HIPAA Privacy and Security Audits Office of the Secretary Office for Civil Rights (OCR) 2012 HIPAA Privacy and Security Audits Linda Sanches OCR Senior Advisor, Health Information Privacy Lead, HIPAA Compliance Audits OCR 1 Agenda Background

More information

AT&T Global Network Client for Windows Product Support Matrix January 29, 2015

AT&T Global Network Client for Windows Product Support Matrix January 29, 2015 AT&T Global Network Client for Windows Product Support Matrix January 29, 2015 Product Support Matrix Following is the Product Support Matrix for the AT&T Global Network Client. See the AT&T Global Network

More information

Welcome to the training on the TransCelerate approach to Risk-Based Monitoring. This course will take you through five modules of information to

Welcome to the training on the TransCelerate approach to Risk-Based Monitoring. This course will take you through five modules of information to Welcome to the training on the TransCelerate approach to Risk-Based Monitoring. This course will take you through five modules of information to introduce you to the concepts behind risk-based monitoring,

More information

OPTIM Associates, Inc. Mobile: (847) 707-7560 PO Box 1006 Toll Free: (877) 332-7475 Lake Villa, IL 60046 Ken.schmidt@optimcorp.com

OPTIM Associates, Inc. Mobile: (847) 707-7560 PO Box 1006 Toll Free: (877) 332-7475 Lake Villa, IL 60046 Ken.schmidt@optimcorp.com OPTIM Associates, Inc. Mobile: (847) 707-7560 PO Box 1006 Toll Free: (877) 332-7475 Lake Villa, IL 60046 Ken.schmidt@optimcorp.com KENNETH B. SCHMIDT, MS 2123 W. Fairview Ave. Johnsburg, IL 60051 Mobile:

More information

Achieving business excellence through quality in a BPO environment

Achieving business excellence through quality in a BPO environment Achieving business excellence through quality in a BPO environment Worldwide BPO Forecast for Horizontal Business Functions, 2004 2009, US$M Worldwide spending on horizontal business process outsourcing

More information

Consolidating Multiple Product Development Systems at TreeHouse Foods into SAP Product Lifecycle Management

Consolidating Multiple Product Development Systems at TreeHouse Foods into SAP Product Lifecycle Management Consolidating Multiple Product Development Systems at TreeHouse Foods into SAP Product Lifecycle Management Kathy Kugelman, TreeHouse Foods Robin Patrawala, Linx-AS SESSION CODE: PL1288 AGENDA About TreeHouse

More information

Quality Risk Management ICH Q9 & ISO 14971. Presented by Michael Kerr 11 th November 2011

Quality Risk Management ICH Q9 & ISO 14971. Presented by Michael Kerr 11 th November 2011 Quality Risk Management ICH Q9 & ISO 14971 Presented by Michael Kerr 11 th November 2011 Agenda Risk Concept QRM Fundamentals Regulatory Expectations Warning Letters / Observations Application of QRM Introduction:

More information

WHITE PAPER IT SERVICE MANAGEMENT IT SERVICE DESIGN 101

WHITE PAPER IT SERVICE MANAGEMENT IT SERVICE DESIGN 101 WHITE PAPER IT SERVICE MANAGEMENT IT SERVICE DESIGN 101 Prepared by: Phillip Bailey, Service Management Consultant Steve Ingall, Head of Service Management Consultancy 60 Lombard Street London EC3V 9EA

More information

GxP Process Management Software. White Paper: Software Automation Trends in the Medical Device Industry

GxP Process Management Software. White Paper: Software Automation Trends in the Medical Device Industry GxP Process Management Software : Software Automation Trends in the Medical Device Industry Introduction The development and manufacturing of a medical device is an increasingly difficult endeavor as competition

More information

www.pwchk.com Inspiration for what is possible Inspiring new possibilities for your business with PwC and Oracle

www.pwchk.com Inspiration for what is possible Inspiring new possibilities for your business with PwC and Oracle www.pwchk.com Inspiration for what is possible Inspiring new possibilities for your business with PwC and Oracle Oracle Business Applications Practice Overview December 2013 Inspiring new possibilities

More information

Management of the Supply Chain: Excipients & APIs. Janeen Skutnik Wilkinson Director, Quality Strategy Pfizer

Management of the Supply Chain: Excipients & APIs. Janeen Skutnik Wilkinson Director, Quality Strategy Pfizer Management of the Supply Chain: Excipients & APIs Janeen Skutnik Wilkinson Director, Quality Strategy Pfizer 1.8 Quality Manual/Quality Policy Pfizer has integrated much of the supply chain Quality elements

More information

Complacency is not an Option

Complacency is not an Option Complacency is not an Option Frank Deane, Ph.D., President, Global Manufacturing, Eli Lilly and Company 2 Agenda Lilly s manufacturing quality transformation journey Lilly s quality system Control strategy

More information

www.pwc.nl Procurement Transformation: Towards Sourcing & Procurement Excellence

www.pwc.nl Procurement Transformation: Towards Sourcing & Procurement Excellence www.pwc.nl Procurement Transformation: Towards Sourcing & Procurement Excellence PwC firms provide Industry-focused Assurance, Tax and Advisory services to enhance value for their clients. More than 161.000

More information

Safety Assurance Cases: What the medical device industry is doing

Safety Assurance Cases: What the medical device industry is doing Safety Assurance Cases: What the medical device industry is doing Sherman Eagles SoftwareCPR seagles@softwarecpr.com BECOMING AWARE 3 Early steps to awareness 2005 EWICS TC7 medical device group begins

More information

Tying It All Together: Practical ERM Integration. Richard Scanlon Vice President Enterprise Risk Management CIGNA Corporation

Tying It All Together: Practical ERM Integration. Richard Scanlon Vice President Enterprise Risk Management CIGNA Corporation Tying It All Together: Practical ERM Integration Richard Scanlon Vice President Enterprise Risk Management CIGNA Corporation November 16, 2007 1 Agenda Basis for ERM Integration ERM Objectives ERM Focus

More information

DECEMBER WEBINAR: CLIENT REPORTING UPDATE

DECEMBER WEBINAR: CLIENT REPORTING UPDATE DECEMBER WEBINAR: CLIENT REPORTING UPDATE Shelley Snelson > Head of Client Reporting Lisa White > Project Manager Nicola Wall > Technology Product Owner Not for redistribution Agenda 1 2 3 4 Current Reporting

More information

Loss Control Webinar Series. The Year That Was: 2014 (And On the Horizon in 2015)

Loss Control Webinar Series. The Year That Was: 2014 (And On the Horizon in 2015) Loss Control Webinar Series The Year That Was: 2014 (And On the Horizon in 2015) Sonia M. Valdes, Esq. Vice President-Medmarc Carolyn Taylor, Esq. Partner, Morris Polich and Purdy 1 Presentation Topics

More information

Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH

Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH VWR enables the advancement of science by providing high-quality chemicals and services, customized to your

More information

What s New In ITIL V3?

What s New In ITIL V3? What s New In ITIL V3? George Spalding VP, Global Events Pink Elephant Pink Elephant Leading The Way In IT Management Best Practices The ITIL Books (V2) T h e B u s i n e s s Planning To Implement Service

More information

EMC Information Intelligence Group Quarterly Partner Webcast

EMC Information Intelligence Group Quarterly Partner Webcast INDUSTRIES : : BUSINESS WITH PARTNERS EMC Information Intelligence Group Quarterly Partner Webcast Chris McLaughlin VP, WW Channels & Alliances General Manager, Energy & Engineering Roy Nicholson General

More information

FDA/Industry Collaborative Approach to Quality: With the Patient in Mind

FDA/Industry Collaborative Approach to Quality: With the Patient in Mind FDA/Industry Collaborative Approach to Quality: With the Patient in Mind A proposal submitted by Xavier University for FDA and Industry consideration Based upon presentations and dialogue during the FDA/Xavier

More information

KPIs: Measuring Indirect Material Suppliers and Service Providers

KPIs: Measuring Indirect Material Suppliers and Service Providers KPIs: Measuring Indirect Material Suppliers and Service Providers Karen M. Fedele, C.P.M. Category Manager The Gillette Company 617.421.8382 Karen_Fedele@gillette.com Tim Dolan, C.P.M. Manager, Strategic

More information

www.pwc.com Next presentation starting soon Next Gen Customer Experience Enabled by PwC & Oracle s Cloud CRM & CX Applications

www.pwc.com Next presentation starting soon Next Gen Customer Experience Enabled by PwC & Oracle s Cloud CRM & CX Applications www.pwc.com Next presentation starting soon Next Gen Customer Experience Enabled by & Oracle s Cloud CRM & CX Applications Agenda Introductions & Customer Experience / CX Defined Why CX is Critical Today?

More information

RTI Software Development Methodology and CMMI

RTI Software Development Methodology and CMMI RTI Software Development Methodology and CMMI Presented at International Field Directors & Technologies Conference Karen M. Davis Vice President, Research Computing Division May 20, 2008 3040 Cornwallis

More information

2006-2167: PREPARING BIOMEDICAL ENGINEERS FOR CAREER ADVANCEMENT: THE HEALTHCARE TECHNOLOGIES MANAGEMENT PROGRAM

2006-2167: PREPARING BIOMEDICAL ENGINEERS FOR CAREER ADVANCEMENT: THE HEALTHCARE TECHNOLOGIES MANAGEMENT PROGRAM 2006-2167: PREPARING BIOMEDICAL ENGINEERS FOR CAREER ADVANCEMENT: THE HEALTHCARE TECHNOLOGIES MANAGEMENT PROGRAM Jay Goldberg, Marquette University Dr. Goldberg is the Director of the Healthcare Technologies

More information

Session Objectives: National Consortium for Continuous Improvement in Higher Education

Session Objectives: National Consortium for Continuous Improvement in Higher Education KISS: Learning to Simplify Session Objectives: Change Leadership at Cornell The challenge of leading college and administration realignment at a university What are the complexities of leading change for

More information

Building a Culture of Quality in Food and Beverage Manufacturing. The Role of Integrated Business Systems in a Volatile Regulatory Environment

Building a Culture of Quality in Food and Beverage Manufacturing. The Role of Integrated Business Systems in a Volatile Regulatory Environment Building a Culture of Quality in Food and Beverage Manufacturing The Role of Integrated Business Systems in a Volatile Regulatory Environment How to Interact Slides will advance automatically Q&A period

More information