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Speaker Firms and Organization:
Thermo Fisher Scientific
Lee Young
Director Supplier Quality
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March 27, 2015
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March 27, 2015
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Sparta Systems, Inc., an industry pioneer and global
provider of quality management soluti...
Brief Speaker Bios:
Ivan Latanision
Ivan Latanision is responsible for overseeing Sparta System’s Product Management and S...
Brief Speaker Bio:
Nicky Dodsworth
Nicky is Vice President, Global Quality Assurance for Premier Research, a Contract Rese...
Supplier Quality Management (SQM) is becoming an important business practice as more companies are out-sourcing manufactur...
Featured Speakers:
March 27, 2015
10
SEGMENT 1:
Ivan Latanision
Vice President, Product Management and Strategy
Sparta Sys...
Introduction
Ivan Latanision is responsible for overseeing Sparta System’s Product Management and Strategy organization. H...
What we’ll discuss
 The impact & cost of poor quality
 Industry challenges
 How organizations are managing supplier qua...
The impact of poor quality
March 27, 2015
13
SEGMENT 1:
Ivan Latanision
Vice President, Product Management and Strategy
Sp...
The impact of poor quality
March 27, 2015
14
SEGMENT 1:
Ivan Latanision
Vice President, Product Management and Strategy
Sp...
15
Let’s do the math
March 27, 2015
1 raps.org, A. Gaffney, “Number of Drug Recalls Surges at FDA, Led by Mid-Level Concer...
16
Let’s do the math
March 27, 2015
Cost of drug
recalls in 2013 $12B to $110B
52% of recalls due
to suppliers/vendors $6B...
Industry challenge: Identifying Quality Issues Early
March 27, 2015
17
SEGMENT 1:
Ivan Latanision
Vice President, Product ...
Industry challenge: Supply chain complexity
March 27, 2015
18
SEGMENT 1:
Ivan Latanision
Vice President, Product Managemen...
Industry challenge: Supplier visibility
March 27, 2015
19
SEGMENT 1:
Ivan Latanision
Vice President, Product Management an...
Supplier Quality Maturity Framework
Mastery of each step leads to improved visibility and quality across the supplier netw...
Best Practices for Managing Quality In the Supply Chain
March 27, 2015
21
SEGMENT 1:
Ivan Latanision
Vice President, Produ...
Best Practices for Managing Quality In the Supply Chain
March 27, 2015
22
SEGMENT 1:
Ivan Latanision
Vice President, Produ...
Best Practices for Managing Quality In the Supply Chain
March 27, 2015
23
SEGMENT 1:
Ivan Latanision
Vice President, Produ...
Best Practices for Managing Quality In the Supply Chain
March 27, 2015
24
SEGMENT 1:
Ivan Latanision
Vice President, Produ...
Extend quality management practices into the supply chain
Visibility - Identify issues early before they become costly qua...
March 27, 2015
26
CLE PROCESSING
The Knowledge Group offers complete CLE processing solutions for your webcasts and land e...
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PRIVATE LABEL PROGRAM & INTERNAL TRAINING
The Knowledge Group provides complete private label webcasts a...
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RESEARCH & BUSINESS PROCESS OUTSOURCING
The Knowledge Group specializes in highly focused and intelligen...
Introduction
Lee is currently the director of supplier quality at Thermo Fisher Scientific. For 20 years Lee has worked in...
What we will be discussing
• Software risk systems that are now the talk of the industry and how best to best approach the...
Risk Software the New Supplier Quality Buzz Phrase
• In this ‘LinkedIn’ age we live in supplier management risk software i...
Supply Chain Risk Management
• With any supply chain disaster, the rippling effects of factory damage or shut
downs can be...
How to get started
• There are at least 3 software providers in the marketplace to evaluate and
understand advantages and ...
Switching Direction: Increasing compliance and risk in
Genetic Sequencing.
Though the structure of DNA was established as ...
This is really sensor technology
• Due to rapid growth in cell phone cameras and back up cameras in the
automotive industr...
What can you do?
• With any new technology what can you do? You can bring it inside into a GMP
environment and drive compl...
Introduction
Nicky is Vice President, Global Quality Assurance for Premier Research, a Contract Research Organisation that...
Agenda Items
• Are Quality Agreements a vital part in ensuring quality/defining relationships or are they just another
doc...
Quality Agreements
Are Quality Agreements a vital part in ensuring quality/defining relationships or are they just
another...
Quality Agreements
March 27, 2015
40
SEGMENT 3:
Nicky Dodsworth
VP Global Quality Assurance
Premier Research
Pros Cons
• D...
Metrics
Metrics – The Good & the Bad: their role in oversight of outsourced activities
March 27, 2015
41
SEGMENT 3:
Nicky ...
Metrics
March 27, 2015
42
SEGMENT 3:
Nicky Dodsworth
VP Global Quality Assurance
Premier Research
Low
Cost
High
Cost
Refer...
The Essentials
The Essentials: clear Contracts, good Communication and avoiding Conflicting goals
March 27, 2015
43
SEGMEN...
The Essentials
March 27, 2015
44
SEGMENT 3:
Nicky Dodsworth
VP Global Quality Assurance
Premier Research
Contracts
• Timel...
Quality by Design (QbD)
How to apply QbD principles to vendor selection and qualification
March 27, 2015
45
SEGMENT 3:
Nic...
Quality by Design (QbD)
March 27, 2015
46
SEGMENT 3:
Nicky Dodsworth
VP Global Quality Assurance
Premier Research
Key Conc...
Risk Assessment & Management
March 27, 2015
47
SEGMENT 3:
Nicky Dodsworth
VP Global Quality Assurance
Premier Research
Ide...
QbD Process for Vendors
March 27, 2015
48
SEGMENT 3:
Nicky Dodsworth
VP Global Quality Assurance
Premier Research
Collect
...
Applying CQAs and CPPs to Create Vendor Checklist
March 27, 2015
49
SEGMENT 3:
Nicky Dodsworth
VP Global Quality Assurance...
Summary – How to Improve Quality
• A good Quality Management System will specify how vendors are selected, auditing freque...
► You may ask a question at anytime throughout the presentation today. Simply click on the question mark icon located on t...
March 27, 2015
52
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Supplier Quality Management: Best Practices and Practical Insights in 2015 LIVE Webcast

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Supplier Quality Management (SQM) is becoming an important business practice as more companies are out-sourcing manufacturing, distribution, shipping, and sales across the globe. Aside from the implications of failure to comply with a myriad of regulations, failure of SQM can lead to litigation, added costs, and harmed reputation among other problems such as product adulteration and mis-branding. However, there is a trade-off between managing supplier quality and costs. As such, SQ managers need to be aware of the risks and benefits of the relationship with suppliers as a whole.

Our panel of key thought leaders and practitioners assembled by The Knowledge Group will discuss Supplier Quality Management and provide Best Practices and Practical Insights.

Key topics include:

Supplier Quality Management – Overview
Supplier Selection, Evaluation, and Monitoring
Supplier Quality Agreements and Contracts
Cost of Poor Supplier Quality (COPQ)
Quality Management Systems
Cost Recovery and Supplier Audit
Closed Loop Corrective Actions
Suppliers Quality Metrics
Supply Chain Pressures

To view the webcast go to this link: http://youtu.be/FhW15o2pfCw

To learn more about the webcast please visit our website: http://theknowledgegroup.org

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Supplier Quality Management: Best Practices and Practical Insights in 2015 LIVE Webcast

  1. 1. Speaker Firms and Organization: Thermo Fisher Scientific Lee Young Director Supplier Quality Thank you for logging into today’s event. Please note we are in standby mode. All Microphones will be muted until the event starts. We will be back with speaker instructions @ 11:55am. Any Questions? Please email: Info@knowledgecongress.org Group Registration Policy Please note ALL participants must be registered or they will not be able to access the event. If you have more than one person from your company attending, you must fill out the group registration form. We reserve the right to disconnect any unauthorized users from this event and to deny violators admission to future events. To obtain a group registration please send a note to info@knowledgecongress.org or call 646.202.9344. Presented By: March 27, 2015 1 Partner Firms: Sparta Systems, Inc. Ivan Latanision Vice President, Product Management and Strategy Premier Research Nicky Dodsworth VP Global Quality Assurance
  2. 2. March 27, 2015 2  Follow us on Twitter, that’s @Know_Group to receive updates for this event as well as other news and pertinent info.  If you experience any technical difficulties during today’s WebEx session, please contact our Technical Support @ 866-779-3239.  You may ask a question at anytime throughout the presentation today via the chat window on the lower right hand side of your screen. Questions will be aggregated and addressed during the Q&A segment.  Please note, this call is being recorded for playback purposes.  If anyone was unable to log in to the online webcast and needs to download a copy of the PowerPoint presentation for today’s event, please send an email to: info@knowledgecongress.org. If you’re already logged in to the online webcast, we will post a link to download the files shortly.  If you are listening on a laptop, you may need to use headphones as some laptops speakers are not sufficiently amplified enough to hear the presentations. If you do not have headphones and cannot hear the webcast send an email to info@knowledgecongress.org and we will send you the dial in phone number.
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  6. 6. Partner Firms: March 27, 2015 6 Sparta Systems, Inc., an industry pioneer and global provider of quality management solutions, enable organizations to safely and efficiently deliver products and services to market. Its TrackWise Enterprise Quality Management Solution is the trusted standard among highly regulated industries, including Food & Beverage, Pharmaceutical, Chemical and Medical Device manufacturing. TrackWise is used worldwide by quality, manufacturing and supply chain professionals to optimize quality, protect brand reputation, and improve safety across the value chain. Provides analytical instruments, equipment, reagents and consumables, software, and services for research, manufacturing, analysis, discovery, and diagnostics in the United States and internationally. Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs with a special focus on addressing unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. Premier Research operates in 50 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.
  7. 7. Brief Speaker Bios: Ivan Latanision Ivan Latanision is responsible for overseeing Sparta System’s Product Management and Strategy organization. His team provides the company’s product vision and strategy. Most recently, Ivan was the Chief Product Officer at INTTRA, a global e-commerce platform for the ocean cargo industry. Ivan was responsible for the company’s product vision, strategy and execution, from concept to implementation and support. Prior to INTTRA, Ivan was the Chief Technology Officer for SourceMedia, Inc. (formerly Thomson Media, a subsidiary of Thomson Reuters), where he was responsible for managing several functions, including IT, product development, technology operations, infrastructure, and corporate systems. March 27, 2015 7 Lee Young Lee is currently the director of supplier quality at Thermo Fisher Scientific. For 20 years Lee has worked in supplier quality for companies like L-3 Communication, Intel Corporation, CareFusion and Life Technologies. Lee received his bachelors in chemical engineering from the University of Arizona and completed coursework for his masters at Arizona State University, also in chemical engineering. Lee currently sits on the industry advisory board at the University of San Diego for the industrial engineering department.
  8. 8. Brief Speaker Bio: Nicky Dodsworth Nicky is Vice President, Global Quality Assurance for Premier Research, a Contract Research Organisation that assists biopharmaceutical and medical device companies develop their therapies and devices especially in the areas of paediatric medicine and rare diseases. She has over 20 years of experience in global clinical trials mainly in the development, maintenance and oversight of quality management systems. As an active member of the European Forum for Good Clinical Practice (EFGCP), she was appointed Chair of the Education Working Party in 2011. Nicky runs an accredited European Medical Writers Association (EMWA) Workshop on Quality Awareness in Clinical Study Report Development. She is Co-Chair of the GCP Forum for the Institute of Clinical Research (ICR) and a member of the editorial board of the CRfocus journal. March 27, 2015 8 ► For more information about the speakers, you can visit: http://theknowledgegroup.org/event_name/supplier-quality-management-best-practices-and-practical-insights-in-2015-live-webcast/
  9. 9. Supplier Quality Management (SQM) is becoming an important business practice as more companies are out-sourcing manufacturing, distribution, shipping, and sales across the globe. Aside from the implications of failure to comply with a myriad of regulations, failure of SQM can lead to litigation, added costs, and harmed reputation among other problems such as product adulteration and mis-branding. However, there is a trade-off between managing supplier quality and costs. As such, SQ managers need to be aware of the risks and benefits of the relationship with suppliers as a whole. Our panel of key thought leaders and practitioners assembled by The Knowledge Group will discuss Supplier Quality Management and provide Best Practices and Practical Insights. Key topics include: • Supplier Quality Management - Overview • Supplier Selection, Evaluation, and Monitoring • Supplier Quality Agreements and Contracts • Cost of Poor Supplier Quality (COPQ) • Quality Management Systems • Cost Recovery and Supplier Audit • Closed Loop Corrective Actions • Suppliers Quality Metrics • Supply Chain Pressures March 27, 2015 9
  10. 10. Featured Speakers: March 27, 2015 10 SEGMENT 1: Ivan Latanision Vice President, Product Management and Strategy Sparta Systems, Inc. SEGMENT 2: Lee Young Director Supplier Quality Thermo Fisher Scientific SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research
  11. 11. Introduction Ivan Latanision is responsible for overseeing Sparta System’s Product Management and Strategy organization. His team provides the company’s product vision and strategy. Most recently, Ivan was the Chief Product Officer at INTTRA, a global e-commerce platform for the ocean cargo industry. Ivan was responsible for the company’s product vision, strategy and execution, from concept to implementation and support. Prior to INTTRA, Ivan was the Chief Technology Officer for SourceMedia, Inc. (formerly Thomson Media, a subsidiary of Thomson Reuters), where he was responsible for managing several functions, including IT, product development, technology operations, infrastructure, and corporate systems. Ivan also served as Senior Director of Product Marketing at Reciprocal, Inc., a privately held company founded by Microsoft, as well as various technology and operational roles at Thomson Financial Media and other media companies. Ivan earned BS and MS degrees from the Rochester Institute of Technology and an MBA from Rutgers University. March 27, 2015 11 SEGMENT 1: Ivan Latanision Vice President, Product Management and Strategy Sparta Systems, Inc.
  12. 12. What we’ll discuss  The impact & cost of poor quality  Industry challenges  How organizations are managing supplier quality today  Four SQM best practices that you can do now March 27, 2015 12 SEGMENT 1: Ivan Latanision Vice President, Product Management and Strategy Sparta Systems, Inc.
  13. 13. The impact of poor quality March 27, 2015 13 SEGMENT 1: Ivan Latanision Vice President, Product Management and Strategy Sparta Systems, Inc. product recall increase 1999- 20111 +135% 1 Recall Execution Effectiveness Report. Deloitte, GMA, FMI and GS1. May 2010 2 raps.org, A. Gaffney, “Number of Drug Recalls Surges at FDA, Led by Mid-Level Concerns”, August 2014 6x FDA drug recall increase 2004- 20132
  14. 14. The impact of poor quality March 27, 2015 14 SEGMENT 1: Ivan Latanision Vice President, Product Management and Strategy Sparta Systems, Inc. $90M A product recall can cost an organization between1 $10M 1 Recall Execution Effectiveness Report. Deloitte, GMA, FMI and GS1. May 2010 52% recalls due to supplier/vendor issues1
  15. 15. 15 Let’s do the math March 27, 2015 1 raps.org, A. Gaffney, “Number of Drug Recalls Surges at FDA, Led by Mid-Level Concerns”, August 2014 Drug recalls in 20131 1225 Cost per recall $10M to $90M Cost of drug recalls in 2013 $12B to $110B X
  16. 16. 16 Let’s do the math March 27, 2015 Cost of drug recalls in 2013 $12B to $110B 52% of recalls due to suppliers/vendors $6B to $55B 1% $60M to $550MWhat if improving supplier visibility & quality reduced recalls by… 5% $300M to $2.75B
  17. 17. Industry challenge: Identifying Quality Issues Early March 27, 2015 17 SEGMENT 1: Ivan Latanision Vice President, Product Management and Strategy Sparta Systems, Inc. 1X 10X 100X 1000X… Issue Resolution Cost Supplier Network Corporate Planning & Design Manufacturing Facilities Distribution Centers Consumers Only 22%of companies see quality as an integrated function of their supply chains1. 1 Gartner, S Jacobson, “Quality: The Missing Link in Your Supply Chain Strategy”, January 2015
  18. 18. Industry challenge: Supply chain complexity March 27, 2015 18 SEGMENT 1: Ivan Latanision Vice President, Product Management and Strategy Sparta Systems, Inc. 50-80% of the total product costs are spent on raw materials & parts procured from multiple suppliers across different parts of the globe1 1 The Supplier Performance Measurement Benchmarking Report, Aberdeen Group, 2002
  19. 19. Industry challenge: Supplier visibility March 27, 2015 19 SEGMENT 1: Ivan Latanision Vice President, Product Management and Strategy Sparta Systems, Inc. Complete visibility Tier 1, 2 and beyond suppliers visibility Limited visibility Limited Tier 1 supplier visibility, but not Tier 2 & beyond Some visibility Tier 1 supplier visibility & some Tier 2 supplier visibility 22% 38%40% Only 22% of today’s manufacturers have complete visibility into their supply chain1 1KPMG Global Manufacturing Outlook report, 2014
  20. 20. Supplier Quality Maturity Framework Mastery of each step leads to improved visibility and quality across the supplier network March 27, 2015 20 Level 1 Level 2 Level 3 Level 4 Level 5 Ad-hoc Email communication Fax communication Manual data capture Supplier Scorecard Repeatable Supplier Agreements Electronic data capture & spreadsheets Approved Supplier List Collaborative Quality Network Integration Quality Network Collaboration Quality Network Visibility Historical Performance / Automated Scorecard Automated System Driven Centralized Supplier Management Metrics and KPIs Tier 1 Supplier Collaboration Predictive Insights & Triggered Events Optimized Tier 1 Supplier Visibility
  21. 21. Best Practices for Managing Quality In the Supply Chain March 27, 2015 21 SEGMENT 1: Ivan Latanision Vice President, Product Management and Strategy Sparta Systems, Inc. Broaden supplier assessments Enable broader visibility into the supplier network 45% of executives agree the leading challenges to supply chain efficiency include supplier performance and quality management - KPMG Global Manufacturing Outlook report 2013 1
  22. 22. Best Practices for Managing Quality In the Supply Chain March 27, 2015 22 SEGMENT 1: Ivan Latanision Vice President, Product Management and Strategy Sparta Systems, Inc. Establish clear measurement programs Leverage automation tools to support measurement & monitoring of supplier quality DynamicSupplierScorecard Real-Time Consistent Accurate Prioritize Schedule Manage Informed Systematic Efficient Execute Consistent Remediate Integrated Measure Accurate Decisions Complete Measure and Inform Audit Management Audit Execution Audit Planning Supplier Audit Checklist 2
  23. 23. Best Practices for Managing Quality In the Supply Chain March 27, 2015 23 SEGMENT 1: Ivan Latanision Vice President, Product Management and Strategy Sparta Systems, Inc. Invest in infrastructure Enable quality across the supply chain through effective communication of quality events Cloud Computing will play the most important role in IT enabling quality between now & 2017 - Gartner, S Jacobson, “Quality: The Missing Link in Your Supply Chain Strategy”, January 2015 Supplier 1 Supplier 2 Supplier 3 3
  24. 24. Best Practices for Managing Quality In the Supply Chain March 27, 2015 24 SEGMENT 1: Ivan Latanision Vice President, Product Management and Strategy Sparta Systems, Inc. Close the quality loop with suppliers Leverage technology to connect & integrate suppliers into quality management processes Quarantine Quality Processes Product Nonconformance  Notification Received  Supplier Identification  Root Cause  CAPA Plan  Effectiveness Check Issue Identified  Notification to Supplier  SCAR  Reviewed  CAPA Approved  Action Item  Reminders 4
  25. 25. Extend quality management practices into the supply chain Visibility - Identify issues early before they become costly quality incidents Traceability - Understand the root cause and source of quality issues in your supply chain Accountability - Ensure supply chain partners understand issues and resolution requirements in a timely manner Profitability - Mitigate quality related financial risk and improve supply chain efficiency March 27, 2015 25 SEGMENT 1: Ivan Latanision Vice President, Product Management and Strategy Sparta Systems, Inc.
  26. 26. March 27, 2015 26 CLE PROCESSING The Knowledge Group offers complete CLE processing solutions for your webcasts and land events. This comprehensive service includes everything you need to offer CLE credit at your conference:  Complete end-to-end CLE credit Solutions  Setting up your marketing collateral properly.  Completing and filing all of the applications to the state bar.  Guidance on how to structure content meet course material requirements for the state Bars.  Sign up forms to be used to check & confirm attendance at your event.  Issuing official Certificates of Attendance for credit to attendees. Obtaining CLE credit varies from state to state and the rules can be complex. The Knowledge Group will help you navigate the complexities via complete cost effective CLE solutions for your conferences. Most CLE processing plans are just $499 plus filing fees and postage. To learn more email us at info@knowledgecongress.org or CALL 646-202-9344
  27. 27. March 27, 2015 27 PRIVATE LABEL PROGRAM & INTERNAL TRAINING The Knowledge Group provides complete private label webcasts and in-house training solutions. Developing and executing webcasts can be a huge logistical nightmare. There are a lot of moving parts and devolving a program that is executed smoothly and cost effectively can prove to be a significant challenge for companies who do not produce events on a regular basis. Live events require a high level of proficiency in order to execute proficiently. Our producers will plan and develop your webcast for you and our webcast technicians will execute your live event with expert precision. We have produced over 1000 live webcasts. Put our vast expertise to work for you. Let us develop a professional webcast for your firm that will impress all your clients and internal stakeholders. Private Label Programs Include:  Complete Project Management  Topic Development  Recruitment of Speakers (Or you can use your own)  Marketing Material Design  PR Campaign  Marketing Campaign  Event Webpage Design  Slides: Design and Content Development  Speaker coordination: Arranging & Executing Calls, Coordinating Slides & Content  Attendee Registration  Complete LIVE Event Management for Speaker and Attendees including: o Technical Support o Event Moderator o Running the Live event (All Aspects) o Multiple Technical Back-ups & Redundancies to Ensure a Perfect Live Event o Webcast Recording (MP3 Audio & MP4 Video) o Post Webcast Performance Survey  CLE and CPE Processing Private Label Programs Start at just $999
  28. 28. March 27, 2015 28 RESEARCH & BUSINESS PROCESS OUTSOURCING The Knowledge Group specializes in highly focused and intelligent market and topic research. Outsource your research projects and business processes to our team of experts. Normally we can run programs for less than 50% of what it would cost you to do it in-house. Here are some ideal uses for our services:  Market Research and Production o List Research (Prospects, Clients, Market Evaluation, Sales Lists, Surveys) o Design of Electronic Marketing Collateral o Executing Online Marketing Campaigns (Direct Email, PR Campaigns) o Website Design o Social Media  Analysis & Research o Research Companies & Produce Reports o Research for Cases o Specialized Research Projects  eSales (Electronic Inside Sales – Email and Online) o Sales Leads Development o eSales Campaigns  Inside Sales people will prospect for leased, contact them and coordinate with your sales team to follow up.  Our Inside eSales reps specialize in developing leads for big-ticket enterprise level products and services. o Electronic Database Building – Comprehensive service which includes development of sales leads, contacting clients, scoring leads, adding notes and transferring the entire data set to you for your internal sales reps.  eCustomer Service (Electronic Inside Sales – Email and Online) o Real-Time Customer Service for Your clients  Online Chat  Email o Follow-Up Customer Service  Responds to emails  Conducts Research  Replies Back to Your Customer Please note these are just a few ways our experts can help with your Business Process Outsourcing needs. If you have a project not specifically listed above please contact us to see if we can help.
  29. 29. Introduction Lee is currently the director of supplier quality at Thermo Fisher Scientific. For 20 years Lee has worked in supplier quality for companies like L-3 Communication, Intel Corporation, CareFusion and Life Technologies. Lee received his bachelors in chemical engineering from the University of Arizona and completed coursework for his masters at Arizona State University, also in chemical engineering. Lee currently sits on the industry advisory board at the University of San Diego for the industrial engineering department. March 27, 2015 29 SEGMENT 2: Lee Young Director Supplier Quality Thermo Fisher Scientific
  30. 30. What we will be discussing • Software risk systems that are now the talk of the industry and how best to best approach them. • Increasing compliance and risk in Genetic Sequencing. March 27, 2015 30 SEGMENT 2: Lee Young Director Supplier Quality Thermo Fisher Scientific
  31. 31. Risk Software the New Supplier Quality Buzz Phrase • In this ‘LinkedIn’ age we live in supplier management risk software is becoming more common place and affordable. • Holistic risk management software can give you risk exposure within minutes of major environment catastrophe happening. • This powerful tool allows global companies to establish Global Supply Chain Resiliency groups that take risk management to an entirely new level. • Supply chain luminaries from Amgen, Cisco, EMC, Juniper Networks and MIT are viewing this technology as a key competitive advantage in their marketplace. 31
  32. 32. Supply Chain Risk Management • With any supply chain disaster, the rippling effects of factory damage or shut downs can be immediately felt. Take the 2011 Japanese earthquake as an example. Factories affected by the disaster were shut down, resulting in parts shortages at major suppliers which caused lines down and factory down times at large automotive manufacturers. • Understanding exposure to affected area becomes critical. • Time spent on determine exposure can be up to 500+ hrs. Supply Chain Mapping is the Foundation for a Robust Supply Chain Risk Management Program 32
  33. 33. How to get started • There are at least 3 software providers in the marketplace to evaluate and understand advantages and disadvantages. • Internal company resistance to new technologies has to be overcome. Drive this with example from competitors or companies that currently use this philosophy. • Understanding ROI on quicker response from one major catastrophe pays for the software. • Setting up the system and insuring the mapping is correct is not a insignificant task. 33
  34. 34. Switching Direction: Increasing compliance and risk in Genetic Sequencing. Though the structure of DNA was established as a double helix in 1953, it only been a few years since full genome sequence has been available. This is mostly due to advances in server and sensor technology. Historically this technology was used originally for research use only (RUO) and only recently has progressed to diagnostic clinical applications. 34
  35. 35. This is really sensor technology • Due to rapid growth in cell phone cameras and back up cameras in the automotive industry sensor technology is exploding. • Sensor growth has had double digit growth for almost a decade. • Sequencing technology is also growing at a double digit pace. What does this mean for supplier quality? • All your potential supplier will be in the electronics industry, will be attracted to high volume manufacturing and will be ISO 9001 certified. • You will need ISO 13485 vendors with medical device backgrounds. 35
  36. 36. What can you do? • With any new technology what can you do? You can bring it inside into a GMP environment and drive compliance that way. Or you can…. • Establish robust supplier quality agreements • Establish master supply agreements • Establish key supplier partnerships and spend considerable time with these suppliers • Do gap analysis to GMP and ISO 13485 and drive to close any gaps. This needs to be accomplished against a backdrop of increasing demand from competing industries, increasing regulation and overlying margin pressures. 36
  37. 37. Introduction Nicky is Vice President, Global Quality Assurance for Premier Research, a Contract Research Organisation that assists biopharmaceutical and medical device companies develop their therapies and devices especially in the areas of paediatric medicine and rare diseases. She has over 20 years of experience in global clinical trials mainly in the development, maintenance and oversight of quality management systems. As an active member of the European Forum for Good Clinical Practice (EFGCP), she was appointed Chair of the Education Working Party in 2011. Nicky runs an accredited European Medical Writers Association (EMWA) Workshop on Quality Awareness in Clinical Study Report Development. She is Co-Chair of the GCP Forum for the Institute of Clinical Research (ICR) and a member of the editorial board of the CRfocus journal. Nicky is also a member of the Research Quality Assurance, West & Wales Organising Group which promotes information exchange at a regional level. March 27, 2015 37 SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research
  38. 38. Agenda Items • Are Quality Agreements a vital part in ensuring quality/defining relationships or are they just another document to adhere to? • Metrics – The Good & the Bad: their role in oversight of outsourced activities • The Essentials: clear Contracts, good Communication and avoiding Conflicting goals • How to apply QbD principles to vendor selection and qualification March 27, 2015 38 SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research
  39. 39. Quality Agreements Are Quality Agreements a vital part in ensuring quality/defining relationships or are they just another document to adhere to? March 27, 2015 39 SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research
  40. 40. Quality Agreements March 27, 2015 40 SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research Pros Cons • Defines expectations, standards, metrics etc. at the beginning of the trial process • Aim to promote quality, consistency and communication • To help ensure audit/ inspectional readiness • Another document to follow with potential overlap to contracts, MSAs, Work orders and operational plans • Requires updates and notifications to ensure staff are working to the latest version • It may only apply to only some projects with a sponsor, so communication/ expectations are key • Potential misunderstanding and overlap between QA and Operational ‘Quality’
  41. 41. Metrics Metrics – The Good & the Bad: their role in oversight of outsourced activities March 27, 2015 41 SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research
  42. 42. Metrics March 27, 2015 42 SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research Low Cost High Cost Reference: Improving Quality of Data through Metrics, Quasar, January 2011, S. Hubby and N. Dodsworth Leading vs. Lagging
  43. 43. The Essentials The Essentials: clear Contracts, good Communication and avoiding Conflicting goals March 27, 2015 43 SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research
  44. 44. The Essentials March 27, 2015 44 SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research Contracts • Timely • Ensure they are sufficiently detailed • Team roles need to be clarified • Risk sharing and long- term relationships (preferred vendors) help align to a common vision Communication Conflicting Goals • Team working • Open and honest collaboration • Good environment to ‘listen’ to what people have to say • Solve problems quickly, vendor teams need to be agile • Realistic goals • Common goals that are well communicated to the team • Define priorities, not everything is urgent
  45. 45. Quality by Design (QbD) How to apply QbD principles to vendor selection and qualification March 27, 2015 45 SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research
  46. 46. Quality by Design (QbD) March 27, 2015 46 SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research Key Concepts Quality: The degree to which a set of inherent properties of a product, system, or process fulfills requirements (ICH Q9) State of Control: whereby the set of controls consistently provides assurance of continued process performance and product quality (ICH Q10) Critical Process Parameters (CPP): A process parameter whose variability has an impact on a critical quality attribute (CQA) to ensure the process produces the desired quality (ICH Q8) Process Validation: documented evidence that the process operated within established parameters and is reproducible to its predetermined specifications and quality attributes Quality Risk Management: A systematic process for the assessment, control, communication and review of risks to the quality of the product across the product lifecycle (ICH Q9)
  47. 47. Risk Assessment & Management March 27, 2015 47 SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research Identify Qualify Plan Monitor & Measure
  48. 48. QbD Process for Vendors March 27, 2015 48 SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research Collect Information & In- house Assessment Conduct Initial Risk Assessment Conduct On-site or Remote Audit/ Assessment Reconfirm Use / against areas of non-compliance Continue to Monitor Yes Yes No No
  49. 49. Applying CQAs and CPPs to Create Vendor Checklist March 27, 2015 49 SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research Applying Quality by Design -DIA Euro Meeting March 2013; N. Dodsworth and S. Hubby ExampleCQAs •Whatis the inspection/audit historyof the vendor? •Isthere an independent QA function? •Whatare the qualifications/knowledge base of the teamsproposed? Example CPPs •Isthere a goodQuality ManagementSysteminplace with currentwell-definedSOPs? •Whattrainingprogrammesare in place and whatisrecordedin the trainingrecords? •Are remotereviewsof data possible during the study? Critical Quality Attributes Critical Process Parameters
  50. 50. Summary – How to Improve Quality • A good Quality Management System will specify how vendors are selected, auditing frequency and CAPA resolution • Discontinue use of any vendors who cannot comply with the appropriate regulations • Other “entities” supporting clinical studies (Site Management Organisations (SMOs), data handling/processing companies) are considered vendors – make sure they are assessed and monitored • Audit vendors according to risk, some sort of assessment should be performed for all vendors – it may be more effective to audit when data are being generated • Mutual need to work together, define priorities and realistic time frames, Quality Agreements may work well for you • Set good KRIs and continue to monitor against these • Regulations do not relieve sponsor of responsibility - Concerns about vendors can result in regulatory refusal to accept results in support of marketing applications • Device regulations do not address CROs, therefore device study sponsors are directly responsible for everything contracted to 3rd parties March 27, 2015 50 SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research
  51. 51. ► You may ask a question at anytime throughout the presentation today. Simply click on the question mark icon located on the floating tool bar on the bottom right side of your screen. Type your question in the box that appears and click send. ► Questions will be answered in the order they are received. Q&A: March 27, 2015 51 SEGMENT 1: Ivan Latanision Vice President, Product Management and Strategy Sparta Systems, Inc. SEGMENT 2: Lee Young Director Supplier Quality Thermo Fisher Scientific SEGMENT 3: Nicky Dodsworth VP Global Quality Assurance Premier Research
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