October Courses. ISO 9001: Fundamentals for Sales SEM-001 October 7, 2013

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1 Rubber Division, ACS Courses These courses will be held during our International Elastomer Conference at the I-X Center in Cleveland, OH. ISO 9001: Fundamentals for Sales SEM-001 October 7, 2013 This course is designed to provide sales professionals with a general overview of ISO 9001 as a Quality Management System, as it relates to their customer-oriented selling process. In order to effectively leverage and distinguish your organization from the competition, it is vital that sales, marketing and procurement team members have an understanding of the objectives and benefits of an effective Quality Management System. Participants will learn the concepts of ISO 9001 through the use of hands-on, interactive learning. Length: 1 day Prerequisites: None LEARNING OBJECTIVES - Demonstrate an understanding of the purpose and intent of the ISO 9001 as it relates to a customer oriented selling process - Demonstrate an understanding of the process approach and relate how it impacts the value and quality of your product - Promote the importance of ISO 9001 as a Quality Management System to your customers - Identify Customer Specific Requirements (CSRs) impacting your day-to-day sales and procurement activities WHO SHOULD ATTEND Managers, supervisors and directors involved in the sales and marketing, representatives of the sales, marketing and procurement team AGENDA Purpose and Objectives of ISO 9001 Value of the Process Approach and Impacts Quality Management Principles Customer Specific Requirements Instructor: Plexus Master Trainer CEUs: 0.8 Time: 8:00am 5:00pm Member $450 / Non-Member $550

2 Material Considerations for Medical Devices and Pharmaceutical Products SEM-004 October 8, 2013 This course is designed for engineers, chemists, material designers and supply chain specialists that are interested in learning more about materials that are used in pharmaceutical applications. There is a variety of regulations and expectations for these materials. Basic concepts in managing material changes in the context of this complex environment will be reviewed. After this overview is presented, in-depth training will focus on the selection and qualification of materials. Development of an effective strategy for medical device material selection will be demonstrated. The selection process will be defined and the necessary technical, business, and regulatory inputs identified. It includes examples of the tools necessary to document the critical to quality requirements for the device and translate them in to material requirements to support the selection process. A case study will be reviewed to demonstrate the impact of an effective material selection strategy. Qualification of materials involves several types of testing. Depending on the pharmaceutical application different strategies may be adopted. The participants will be introduced to the various types of testing and be guided through the process of developing an appropriate testing strategy. The use of risk analysis and other tools will be demonstrated. Relevant examples will be given to illustrate interpretation of test results to determine qualification status. The workshop will conclude with two case studies that illustrate how regulations and industry expectations for pharmaceutical materials can be reasonably addressed. Perspectives from a raw material supplier and component fabricator will be represented. Learning objectives for this workshop include: - developing an understanding of regulatory and industry expectations for materials used in pharmaceutical applications. - learning how to use various tools to effectively select and test materials. - becoming familiar with practical approaches to meet regulatory and industry expectations. Instructors: Lisa Dick, 3M; Glenn White, Novartis; Dr. Dave Albert, NAMSA; Steve Blazey, Diamond; Cheryl Stults, Novartis; Peg Frandalog, West Pharmaceutical CEUs: 0.4 Time: 8:00am 12:00pm $249 / $349 member $425 / $525 non-member

3 Lean Design Overview for Sales SEM-003 October 8, 2013 This course is designed to provide participants with an overview of lean design concepts, thinking and techniques. The focus is placed on the importance and benefits of lean implementation and is intended to enhance your ability to communicate with internal and external customers as it relates to lean manufacturing. This course is ideal for those who want to expand their knowledge of lean design and improve their ability to leverage this knowledge during day-to-day activities. Length: 1 day Prerequisites: None LEARNING OBJECTIVES - Demonstrate an understanding of the purpose and intent of lean design as it relates to a customer oriented selling process - Identify how lean product design delivers optimum value while preventing waste (cost, quality, time) - Promote the importance of lean design to your customers - Identify Customer Specific Requirements (CSRs) relating to lean concepts and thinking - Demonstrate an understanding of how lean concepts and thinking affect the organization s dayto-day activities WHO SHOULD ATTEND Managers, supervisors and directors involved in the sales and marketing, representatives of the sales, marketing and procurement team, and any team members who may benefit from an overview of lean design AGENDA Purpose and Objectives of Lean Design Lean Design Concepts, Thinking and Techniques Overview of Lean Toolkit Value of Lean Design Instructor: Plexus Master Trainer CEUs: 0.8 Time: 8:00am 5:00pm Member $ / Non-Member $ Selecting the Right Elastomer for Your Sealing Application SEM-005 October 8, 2013 We will review the different elastomers and how they compare to each other. We will look at chemical compatibility, thermal properties and mechanical properties of elastomers used in sealing applications. Also discussed will be how to specify elastomers for your application, service conditions to consider and cost vs. value in selecting an elastomer.

4 Instructor: William Stahl, Rainbow Master Mixing CEUs: 0.3 Time: 1:00pm 4:00pm $199 / $299 member $349 / $449 non member Chemistry and Technology of Polyurethane Elastomers SEM-006 October 9, 2013 This course focuses on the fundamentals of elastomeric polyurethanes such as those used in coatings, adhesives, sealants or elastomers ( CASE ). The course includes identification of major raw materials, an introduction to polymer chemistry and chemical structure-property relationships in elastomeric polyurethanes. Testing and analysis techniques, typical formulary and key processing methods are discussed in the context of key markets such as medical device, oil field, materials handling, architectural and materials handling applications. Those Who Should Attend: Product engineers, managers, quality professionals and Jr. or Sr. level-chemists. Suggested pre-requisites include general technical aptitude and general familiarity of technical terminology related to chemistry and rubber or plastic materials. Course Outline: Introduction: CASE market overview Polymer and functional group chemistry of polyurethanes Structure-property relationships and key raw materials Testing and analytical methods Processing methods Case examples of typical polyurethane formulary Instructor: Dave Russell, Biomerics, LLC CEUs: 0.4 Time: 8:00am 12:00pm $249 / $349 member $425 / $525 non-member

5 Introduction to Rubber Technology for Non-Technologists SEM-008 October 9, 2013 If you are new to the industry, working in engineering, sales, administration, human resources or any other non-technical area, and you d like a very basic, easy to understand introduction to the jargon of the trade and what goes on in the factory and lab, then this one-day course is perfect for you. You won t come out a rubber expert, but you will understand all the basics of the technology and the language of the business. The course material will cover: - what polymers are, how rubber is different from plastic. - how recipes for rubber compounds are created and why. - what s involved in mixing, processing and vulcanizing rubber. - testing, specifying and quality control of rubber products. Instructor: RJ DelVecchio, Consultant CEUs: 0.7 Time: 8:30am 4:30pm $425 / $525 member $580 / $680 non member $50 / $50 student/ emeritus Chemistry and Technology of Functional Coatings for Medical Devices SEM-007 October 9, 2013 This course focuses on coatings and other secondary treatments of medical devices where the coating or treatment is intended to impart anti-static, low friction, low wear, anti-microbial, antithrombogenic, or other functional property not inherent in the device s material of construction. The discussion focuses primarily on polymeric substrates such as catheters, introducers, blood pumps, orthopedic devices, wound care, and other implantable and nonimplantable devices. Technologies discussed include: Pharma based systems such as heparin and antibiotic types; hydrophilics based on PVP, PEG, PEO type structures; biomimetics and other polymer surfactants; silver and ceramic based systems; and fluoro and silicone modifiers. Those Who Should Attend: Product engineers, managers, quality professionals and Jr. or Sr. level-chemists. Suggested pre-requisites include general technical aptitude and general familiarity of technical terminology related to chemistry and rubber or plastic materials.

6 Course Outline: Introduction and market overview Overview of physics, chemistry and/or physiology of anti-stats, antimicrobials, anti-thrombogenic treatments Chemistry and technology of commercially significant systems Review of emerging technologies Instructor: Dave Russell, Biomerics, LLC CEUs: 0.4 Time: 1:00pm 5:00pm $249 / $349 member $425 / $525 non-member Introduction to Carbon Black: Manufacture, Testing and Influence on Rubber Compound Properties SEM-009 October 10, 2013 This course will introduce the attendee to the basics of the most important filler used in rubber compounds. A brief history of carbon black will be provided from its original purpose as a pigment through the discovery of its substantial reinforcing properties in natural rubber compounds to its current status as the largest volume filler used in tires and most other rubber products today. The course will cover the following aspects of carbon black technology: the various methods of producing carbon black with most emphasis on the furnace process, colloidal, chemical and pellet property testing, dispersion testing, and the influence of carbon black structure and surface area properties on rubber compounds. Instructor: Joel Neilsen, Sid Richardson CEUs: 0.3 Time: 8:00am 11:00am $199 / $299 member $349 / $449 non member Register for these courses at Contact Christie Robinson, MEd, Education and Publications Manager, at crobinson@rubber.org for more information. Visit for more Rubber Division, ACS educational opportunities.

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