TRAVEL INFORMATION

VENUE & ACCOMMODATION The 2016 FPID Symposium will be held at Rochestown Park Hotel, Cork, Ireland. This modern hotel offers luxury accommodations and is located right in the Pharma center of Ireland.

HOTEL REGISTRATION We have arranged a discounted hotel rate of €110/night for symposium attendees for the Mon, Tues, and Wed nights. Please mention “ISA 2016 FPID Symposium” when booking. If registering on-line use the registration link on the symposium website. The rate includes breakfast, and a rate of €135 is available for double room: Rochestown Park Hotel | Rochestown Road, Douglas, Cork. Tel: 021 4890800| Email: res@rochestownpark.com Web: www.rochestownpark.com

MAP & DIRECTIONS

Flying: The hotel is approximately 10 km from Cork International Airport (airport code: ORK). The airport has a large number of car rental agencies. Taxi service from the airport is available.

2016 Symposium Committee General Symposium Chair ..................David O’Brien, Senior Validation Engineer Symposium Chair......................................................................................Declan Lordan Past Symposium Chair......William J. Dugary, Senior Account Manager, ACE FPID Director and Webmaster………… Andre Michel PE, President, Efficient Plant Inc. Co-Program Chair & ISPE Ireland Liaison……Alan Bateman, Senior Execution Systems Manager, J&J Co-Program Chair………………………………………………..……………... John Murphy Marketing CO-chair ................................................................................... Brian Curtis Marketing CO-chair ............................................................................... Liam O’Brien Social Media Chair ................................................................................ Eoin Ó Riain Paper Reviewers Coordinator…………………….……. Pamela Bruen Docherty Past FPID Director ………………………………………….…………. Michael Baldauff ISA Staff Coordinator .........Rodney Jones, Manager, Divisions and Symposia, ISA

ABOUT THE SYMPOSIUM Competitive forces, changing marketplace dynamics, and regulatory pressures are generating greater demand and need for new and more effective automation technologies in the pharmaceutical and food industries. More than ever before, manufacturing companies are seeking solutions and methodologies that increase quality, safety, reliability, profitability, cost control, and production throughput. The 2016 ISA Food and Pharmaceutical Industries Division (PFID) Symposium will focus on how automation is used to meet the need for increased regulation and quality while reducing manufacturing costs and security threats related to the food, beverage, and pharmaceutical industries. Speakers will present on the latest trends, and provide case studies which demonstrate the effective integration and use of automation to solve these challenges.

WELCOME MESSAGES GENERAL SYMPOSIUM CHAIR

It is my pleasure to welcome you to our 2016 ISA Food and Pharmaceuticals Industries Division Symposium. We have assembled a truly outstanding program this year, featuring some of the world’s most accomplished experts in serialization, process optimization, cyber security and alarm management to name a few. These experts will speak on the vital issues affecting food and drug manufacturers and distributors. We are delighted to have the opportunity to bring this event to Ireland for its first time outside of the United States. Get set to expand your knowledge, meet new people, visit with friends and colleagues, and enjoy all that Cork has to offer. Best Regards David O’Brien Conference Chair, 2016 ISA FPID Symposium

FPID Division On behalf of the entire program committee and the division leadership, I would like to formally welcome you to this year’s 2016 FPID Symposium. Our focus is to help professionals in the food and pharma industries gain a greater understanding of how automation can be applied in the industry to adapt to the changing demand of the market and the regulators.

Our symposium is a two-day event where attendees will experience a breath of learning and continuing education opportunities. Our symposium finishes with two optional training courses on Alarm Management and Cyber security

I also encourage you to visit our exhibit hall, talk with our sponsors, and network with your fellow attendees. From these interactions, you will find out about new techniques, products and approaches to your daily automation challenges.

We are pleased to welcome the full range of automation professionals in our sector to our symposium. This includes both plant people, operations, maintenance, engineering and management, as well as plant designers, instrumentation specialists, and system integration firms. Please take advantage of the professional development opportunities afforded to you by our symposium. Come join us!

Andre Michel, PE FPID Division Director

KEYNOTE SPEAKER Paul McKenzie Senior Vice President Global Biologics Manufacturing & Technical Operations, Biogen

Driving Change Thru Innovation & Standards

We are all familiar with the old adage “better-faster-cheaper, Pick Two”. However, in today’s world of product development and manufacturing, all three are needed and needed now. Organizations are tasked with moving diverse and complex pipelines forward in record time with undivided attention required for product quality, safety, and reliability of manufacturing. These challenges don’t require incremental change in the operating model but revolutionary change in our model. In this talk, we will discuss activities; specifically process and product innovation geared to customer value and standards-based thinking for product lifecycle management and partnership models. We will discuss the implications for the processes, plants and people to ensure successful commercial products.

Paul McKenzie is the Senior Vice President for Global Biologics Manufacturing & Technical Operations at Biogen, recently joining in early 2016. As Senior Vice President for Global Biologics Manufacturing & Technical Operations, Paul is responsible for the Manufacturing, Engineering, and Manufacturing Sciences operations in Denmark, Switzerland, Massachusetts and North Carolina. These facilities cover world-class biopharmaceutical large scale drug substance & finished goods with a focus on Next Generation Automation & Manufacturing. Paul oversees the production of life-changing medicines to patients around the world with five commercial products available including, AvonexTM, TysabriTM, ElocatateTM, AlprolixTM, and PeglidryTM. Paul is a member of the Pharmaceutical Operations & Technology Leadership Team where he brings a strong focus to ensuring clinical supply of product and providing patient convenience. Prior to his current role, Paul was the Vice President of Johnson & Johnson Medical Devices, Ethicon Research & Development (R&D). As a member of the Ethicon Global Management Board and the Johnson & Johnson Medical Devices R&D Leadership Team, Paul was a trusted leader, responsible for R&D’s global strategy, portfolio prioritization and execution, resource strategy & development, and advancement of R&D talent. Paul joined Johnson & Johnson in 2008 as the Head of Bio-Pharmaceutical Development & Manufacturing Support and was later appointed Head of the Global Development Organization of Janssen Pharmaceutical Companies. He also served as Vice President of Manufacturing and Technical Operations directing the Janssen Supply Chain Internal Manufacturing and External Supply Integration functions. Prior to his time at Johnson & Johnson Paul held several executive positions at Bristol-Myers Squibb and Merck. Paul holds a B.S. in Chemical Engineering from the University of Pennsylvania and a Ph.D. in Chemical Engineering from Carnegie Mellon University. He has served on numerous professional and academic boards and is currently a member of the Board of Trustees on the Illinois Institute of Technology and the Society for Biological Engineering.

Peter Martin VP and Edison Master, Schneider Electric Company

Innovation and a Future Perspective on Automation and Control

Industrial Automation is a field in which continual and impactful innovations have occurred over the last century. Today there are a number of key initiatives and technologies in industrial automation, such as the Industrial Internet of Things (IIoT), Cyber-Physical Systems (CPS), industry 4.0, cloud computing, and big data analytics that, taken as a whole, may be indicative of a period of breakthrough innovation that has not been seen since the introduction of the computer as a delivery vehicle for control. This presentation will investigate the different levels of innovation, why industrial automation and control may be at an inflection point leading to inspirational innovation and what this might in terms of performance improvements for Food and Pharmaceutical companies.

Peter Martin, Ph.D., is vice president, business value solutions, for the Software and Industrial Automation division of Invensys plc. He joined The Foxboro Company in 1970 and has worked in a variety of positions in training, engineering, product planning, marketing and strategic planning. He left Foxboro to become vice president at Intech Controls before joining Automation Research Corporation in a similar role. He returned to Invensys in 1996, where he assumed the position of vice-president, marketing, for Foxboro and then chief marketing officer for Invensys Manufacturing and Process Systems before moving into his current position. (GAP BETWEEN PARAGRAPH)

Martin is a world-renowned industry expert. He holds multiple patents, including patents for dynamic performance measures; real-time activity-based costing; closed-loop business control; and asset and resource modeling. He has published numerous articles and technical papers and has authored or co-authored three books: Bottom Line Automation; Dynamic Performance Management: The Pathway to World Class Manufacturing; and Automation Made Easy: Everything you wanted to know about automation – and need to ask. In 2002, Martin was named one of Fortune magazine’s “Hero of U.S. Manufacturing” and one of InTech magazine’s 50 most influential innovators of all time in instrumentation and controls. In 2009, he accepted the ISA Life Achievement Award, recognizing his work in integrating financial and production measures that improve the profitability and performance of industrial process plants.

Time

MONDAY 14th

8:00am Registration - Tea / Coffee - Networking - Exhibition

9:00am Pharma: Serialization Introduction: Andre Michel / Eamonn O'Mathuna GS1 Standard: Siobhan Duggan Implementation: Joe Whyte Serialization info management: Peter Koop

Food and Beverage: Track and Trace Chair - Des Savage How the Internet of Things is driving Track & Trace: Robert Jones Royal Friesland Campina: An example of MES within the Dairy Industry: Predrag Šajinović

10:30am Tea / Coffee - Networking - Exhibition

10:50am Serialization Program approach from a user: Peter Iles Smith

Track and Trace The Business of Buying Serialization : Frank Madden

11:30am Data Integrity Preparing your laboratory for a data integrity audit: Gary Wright Data Integrity: Marc O Reagan

12:30pm Lunch - Networking - Exhibition

1:40pm Official Address: ISA President Mr. Jim Keaveney USA

2:00pm Keynote - Paul McKenzie Driving Change Thru Innovation & Standards

Digitization Automation and digitalization provide advanced paperless manufacturing: Andrew Whytock Food Safety – Five Steps to Digitize and Connect Your Food Safety Program for Compliance + ROI: Joe White

3:30pm Tea / Coffee - Networking - Exhibition

3:50pm Cyber Security Industrial Control Systems Cybersecurity Presents New Challenges for the Automation Profession: Eric Cosman Mitigating Cybersecurity Risk to Life Science Manufacturing: Jim LaBonty Securing your IP in the OT environment: Arjan Meijer

5:20pm Wine Reception - Networking - Exhibition - Draw for Apple Watch

9:00pm Entertainment

Symposium - Day 1

INVITED SPEAKERS

Jim Keaveney President, ISA

Welcome to ISA

Jim Keaveney is ISA President for 2016. He’s been an active ISA member for than 30 years and has served in numerous leadership positions, including Society Treasurer, Finance Committee Chair, and District 2 Vice President. Jim has received numerous ISA honors, including the Distinguished Society, District 2 Golden Eagle, and Lehigh Valley Section Dannenberg Service Awards. He also received a Certificate in Instrumentation from the Philadelphia Section of ISA. Jim is also an ISPE member – Delaware Valley Chapter.

SESSION: Serialization: Chair: Eamonn O'Mathuna Manufacturing Systems Consultant, ESP

Introduction: Liam O’Riordan Serialization Director, ESP

ISA and Serialization:

Andre Michel, PE Président, Efficient Plant Inc.

Serialization Implementation, Operational & Maintenance Challenges: Joe Whyte Global Serialization Lead, Rockwell

Serialization – The role of global standards to enable regulatory compliance: Siobhan Duggan Director of Innovation and Healthcare, GS1 Ireland

Securpharm - System in Germany – Lessons Learned from 3 Years Medicine Verifications: Peter Koop

Director Pharma & Finance Solutions, Arvato systems

Running a large serialization program: Peter Iles-Smith

Technical Director for Manufacturing Execution Systems GSK

As the US deadline is coming and EU is just behind, our symposium will cover the important subject of serialization which affects all level of the pharmaceutical business. From an overview of the need and the technology to a deep dive into the user requirements, this session will provide you the latest information on the world requirements and provide the solution you need to implement in your facility. Lead by world leading companies on the subject, and supported by ISA renowned specialists this half-day session will cover: • The business perspective • The latest news on the requirements from different

countries (which are changing daily) • A deep dive into the standards being used • A perspective from a leader in implementing a solution • An overview on how major pharmaceutical companies

implement their programs

This session will include presenters such as: • Liam Obrien who is ESP Ltd.’s Managing Director and

Serialization/IT Consultant as well as Past President of ISA Ireland Section

• Andre Michel who is leading a serialization effort in Canada and who is the FPID Director for ISA and Editor in the ISA book on serialization

• Siobhan Duggan who works for GS1 which is the organization that established the standards used by most countries for serialization

• Joe White who is the Rockwell Automation serialization leader • Peter Koop of Arvato whom is part of the consortium that will be

managing the serial numbers in Europe • A Program Manager for a major Pharmaceutical manufacturing that

leads the serialization program

Symposium - Day 1 Morning Sessions

SESSION: Track and Trace:

Royal Friesland Campina: An example of MES within the Dairy Industry: Predrag Šajinović ATS

How the Internet of Things is driving Track & Trace. Robert Jones Vision ID

Chair: Desmond Savage MESA

The Business of Buying Serialization: Frank Madden Crest Solution

Product safety, output quality, variability and uniqueness of customer requirements manufacturers are facing increasing demands on the traceability of raw materials, real-time status of manufactured goods and tracking genealogy of products throughout the value chain from single line to the multiple sites of global manufacturers. MESA will chair the session on Track and Trace and how it positions within the greater MES portfolio. The evolution of data systems and technologies being offered means greater benefits for Industry and presenters Vision ID and Crest will show these solutions and the advantage of modernization.

SESSION: Data Integrity:

:

Preparing your laboratory for a data integrity audit: Gary Wright Agilent

Data Integrity Marc O’ Reagan

EMC

Each consumer expects that drugs they consume to be safe and effective. To ensure this, regulatory bodies such as the United States Food and Drug Administration (US FDA), the Irish HPRA have set regulatory standards, to assure proper design, monitoring and control of manufacturing processes and facilities for various systems. This is supported by underlying data to trace manufacturing processes, which can prove evidence that the drugs have been manufactured as per agreed protocols.

Symposium - Day 1 Morning Sessions

SESSION: Digitization:

Automation and digitalization provide advanced paperless manufacturing: Andrew Whytock Siemens

Food Safety – Five Steps to Digitize and Connect Your Food Safety Program for Compliance + ROI Joe Whyte Rockwell

Digitalization in the Industry shows what bringing the worlds of automation and digitalization together to provide true and advanced paperless manufacturing with more complex devices and interconnected data systems as an enabler to integrated operations within industry. Siemens will outline how to achieve using MES as a core concept to create a Digital Plant and optimized solutions with data driven services. Takeda will show an example of their Plant and the journey to Paperless Manufacturing and a real pharmaceutical strategy of integrating automated and manual operations.

SESSION: Cybersecurity:

Industrial Control Systems Cybersecurity Presents New Challenges for the Automation Profession: Eric Cosman, OIT Concepts

Mitigating Cybersecurity Risk to Life Science Manufacturing: Jim LaBonty Pfizer

Securing your IP in the OT environment: Arjan Meijer, Hudson Cybertec XXXXXXXXXXX TWO PICTURES

Without implementing the proper preventative measures, an industrial cyber-attack could contribute to equipment failure, production loss or regulatory violations, with possible negative impacts on the environment or public welfare. Incidents of attacks on these critical network infrastructure and control systems highlight vulnerabilities in the essential infrastructure of our society such as the smart grid, which could become more of a focus for cybercriminals in the future. As well as threats from external sources you also need to take steps to protect your Control and Automation Systems from internal threats which can cripple a company for days or months. International speakers will highlight the nature of these threats, how your systems and infrastructure can be protected, and methods to minimize attacks on your business.

Symposium - Day 1 Afternoon Sessions

Time TUESDAY 15th

8:00am Registration - Tea / Coffee - Networking - Exhibition

9:00am Automation of Biotech Plants Chair: Tommy Fanning Automation Challenges: Martin McAree Automation Challenges: Alan Shefflin Automation Challenges: Barry Lawlor

Process Optimization Process Automation: Francis Ryan Automation Service Solutions for the 21st Century: Kevin Star Prototyping control systems Cormac Garvey

10:30am Tea / Coffee - Networking - Exhibition

10:50am Industry 4.0 (Digital Factory: Automate to Survive) Chair - Martin Corkery Industry 4.0: Alan Norbury The Application of Industrial Internet of Things (IoT) in the form of The Connected Enterprise: Phil George Irish Manufacturing and its readiness for Industry 4.0: Dr. Andrew Lynch

12:30pm Lunch - Networking - Exhibition

1:40pm Official Address: ISA Ireland Section President - Alan Bateman FPID Division Director - Andre Michel

1:50pm Keynote - Peter Martin What is Innovation and What Might be the Future of Automation

2:20pm Equipment Effectiveness Chair: Bill Dugary A Case Study: Transitioning DCS from custom and legacy to current and mainstream: Seamus Mcgrath A Pharmaceutical Case Study: Why Overall Equipment Effectiveness (OEE) Isn’t Enough: Steve Mongahan The Science of Manufacturing: Making OEE work as a Business Performance Metric for your Plant: Arthur Stone

3:30pm Tea / Coffee - Networking - Exhibition

3:50pm Alarm Management Chair: Nick Sands Alarm Management: Emmett O’Connor Alarm System Performance Metrics : Kim Van Camp

5:20pm Wine Reception - Networking - Exhibition - Draw for Apple Watch

Symposium – Day 2

SESSION: Automation Challenges for a Greenfield Biotech Facility (Pharmaceutical):

Chair: Tommy Fanning IDA Ireland

Automation Challenges: Alan Shefflin BMS

Case Study on Delivery of Large Scale Vaccines Project in Belgium : Martin McAree Project Management Group

Plan, Design, Build & Run for Systems in Biotech Facility: Barry Lawlor J&J

Recent advances in biotechnology are helping us prepare for and meet society’s most pressing challenges. As a result, the Biotech industry has seen extensive growth and considerable investment over the last number of years. Automation of Biotech plants has become increasingly important and is seen as a key differentiator for modern Biotech facilities. Repeatable, data rich and reliable operations are an expectation in bringing products to market faster, monitor and predict performance and ensure right first time delivery. This session will provide the most topical trends in automation of Biotech facilities and will show how current best practices will make the difference and deliver greater value to the business.

SESSION: Process Optimization and Rationalization (Food and Beverage)Automation Service Solutions for the 21st Century: Kevin Star ABB

Process Automation: Francis Ryan Glanbia

Prototyping control systems with ISA-S88/S95 Cormac Garvey HAL Software

Incremental Automation Improvement keeps competitiveness - Corporate Control System Standardization - Constant demand for increases in production and quality...

SESSION: Industry 4.0 (Digital Factory: Automate to Survive): Chair: Martin Corkery Enterprise Ireland

Industry 4.0: Alan Norbury Siemens

The Application of Industrial Internet of Things (IoT) in the form of The Connected Enterprise Phil George Rockwell

Irish Manufacturing and its readiness for Industry 4.0 Dr. Andrew Lynch ICMR

The fourth industrial revolution is happening! How is Global Industry and Ireland positioned and what does this mean to Manufacturer's and Industry as a whole. The use of data-driven technologies, the Internet of things (IOT) and Cyber-Physical Systems all integrate intelligently in a

modern manufacturing facility. Enterprise Ireland and the IDA will headline this topic along with the ICMR (Irish Centre for Manufacturing Research) and Industry giants Rockwell and Siemens.

Symposium - Day 2 Morning Sessions

SESSION: OEE and Automation Lifecycle: Plant lifecycle and Operational Equipment Effectiveness

Chair: William Dugary ACE

A Case Study: Transitioning DCS from custom and legacy to current and mainstream: Seamus McGrath Novartis

A Pharmaceutical Case Study: Why Overall Equipment Effectiveness (OEE) Isn’t Enough: Steve Monaghan ACE

The Science of Manufacturing Making OEE works as a Business Performance Metric for your Plant Arthur Stone OEE Systems

Worldwide today many of the over 60 Billion Euro spend in installed control systems are reaching the end of their useful life. However, some of these controls, operational since the 80’s and 90’s, invested significantly in developing their intellectual property and much of what was good then is still good now. Of course some aspects still need to evolve with the times. This requires funding, time and talent. For quite some time now there has been a skilled automation shortage at many companies leading organizations to outsourcing, partnerships and collaboration with SME’s to help manage the institutional knowledge of their installed control systems. With corporate leadership sensitive to return to shareholders, plant renovation approval hurdle rates are usually high when it comes to refreshing these control systems. In many manufacturing facilities, engineers and production managers have been asked to cut costs and yet still advance productivity. To solve this dilemma, many world class facilities continue to focus on driving improvements through the use of automation and information technology. Some are finding that using existing assets in conjunction with focused enhancement efforts can take advantage of both worlds. The papers this afternoon are great examples of where innovation and such experiences are helping to create real value for automation modernization.

SESSION: Alarm Management:

Chair: Nick Sands DuPont

Alarm System Performance Metrics: Kim Van Camp

Building a scalable web based Alarm Analysis system for ISA 18.00.02larm Management Emmett O’Connor TQS

Emerson

DCSs, SCADA systems, PLCs, or Safety Systems use alarms - Ineffective alarm management systems are contributing factors to

many major process accidents.

GUEST SPEAKERS

Alan Bateman ISA Ireland President

Andre Michel, PE ISA Food and Pharma Industry Division Director

ISA Publication Book Director

Symposium - Day 2 Afternoon Sessions

A warm welcome to our 2016 Diamond Sponsor

Special Thanks to all Our Sponsors

Platinum

Gold

Gold

Exhibitors

Bronze

Media and Associations

TRAINING: WEDNESDAY MARCH 16,2016

Wednesday, March 16, 2016 8:00am - 4:00pm Introduction to Industrial Automation Security and the ANSI/ISA-62443 Standards (IC32C)

8:00am - 4:00pm Introduction to the Management of Alarm Systems

OPTIONAL SHORT COURSES Introduction to the Management of Alarm Systems (IC39C) Length: 1 day CEU Credits: 0.7 Course Hours: 8:00 a.m. – 4:00 p.m.

Description:

This course focuses on the key activities of the alarm management lifecycle provided in the ANSI/ISA18.00.02 standard, Management of Alarm Systems for the Process Industries. The activities include the alarm philosophy development, alarm rationalization, basic alarm design, advanced alarm techniques, Human Machine Interface (HMI) design for alarms, monitoring, assessment, management of change, and audit.

You will be able to: • Develop an Alarm Management Philosophy • Identify types of alarms • Discuss rationalization, classification, and prioritization of alarms • Design basic alarms • Determine when advance alarm techniques should be used • Document alarms for operations • Design reports for monitoring and assessment of alarm system performance • Manage changes to alarm systems • Test and audit alarm systems

You will cover: • The Business Case for Alarm Management • The Common Problems in Alarm Systems • The Alarm Management Lifecycle • Philosophy • Identification • Rationalization • Basic Alarm Design • Advanced Alarm Design • HMI Design for Alarms • Implementation • Operation • Maintenance • Monitoring and Assessment • Management of Change • Audit • Starting Points for Alarm Management • Sustaining Alarm Management

Lab and Classroom Exercises: •Alarm identification •Alarm objective analysis •Alarm classification •Alarm prioritization •Alarm monitoring

Recommended Resources:

• Alarm Management: Seven Effective Methods for Optimum Performance, by Bill R. Hollifield and Eddie Habibi

Includes ISA Standard:

•ANSI/ISA18.00.02 Management of Alarm Systems for the Process Industries

If you wish to register offline, download the Training Registration Form, complete, and return to ISA with your payment. Not sure this particular course is for you?

A pre-instructional survey is available for you to evaluate your level of understanding of the course material and to show you the types of questions you’ll be able to answer after completing the course. See more at https://www.isa.org/templates/two-column.aspx?pageid=124407#sthash.SQ07x1QP.dpuf

EVENT STARTS: March 16, 2016

LOCATION: Rochestown Park Hotel $630 USD (€ 575)

$520 USD (€ 475) Members

Introduction to Industrial Automation Security and the ANSI/ISA-62443 Standards (IC32C) Length: 1 day CEU Credits: 0.7 Course Hours: 8:00 a.m. – 4:00 p.m. Description: “It gave me a general overview of how to setup security measures.” – Donald Peck, Utility SCADA Supervisor Understanding how to secure factory automation, process control, and Supervisory Control and Data Acquisition (SCADA) networks is critical if you want to protect them from viruses, hackers, spies, and saboteurs. This seminar teaches you the basics of the ISA/IEC 62443 standards and how these can be applied in the typical factory or plant. In this seminar, you will be introduced to the terminology, concepts, and models, as well as the element of creating a cybersecurity management system, will be explained along with how these should be applied to industrial automation and control systems. You will be able to:

• Discuss why improving industrial security is necessary to protect people, property, and profits· Define the terminology, concepts, and models for electronic security in the industrial automation and control systems environment· Define the elements of the ANSI/ISA-62443-2-1 (ANSI/ISA-99.02.01-2009)- Security for Industrial Automation and Control Systems: Establishing an Industrial Automation and Control Systems Security Program

• Define the core concepts of risk and vulnerability analysis methodologies • Define the concepts of defense in depth and the zone/conduit models of security • Explain the basic principles behind the policy development and key risk mitigation techniques • Explain why improving industrial security will be necessary to protect people, property, and profits

You will cover: • Understanding the Current Industrial Security Environment: What is Electronic Security for Industrial Automation and Control

Systems? | Trends in Security Incidents· How IT and the Plant Floor are Different and How They are the Same· Current Security Standards and Practices

• Creating A Security Program: Critical Factors for Success/Understanding the ANSI/ISA-62443-2-1 (ANSI/ISA-99.02.01-2009) – Security for Industrial Automation and Control Systems: Establishing an Industrial Automation and Control Systems Security Program

• Risk Analysis: Business Rationale |Risk Identification, Classification, and Assessment • Addressing Risk with Security Policy, Organization, and Awareness: CSMS Scope | Organizational Security | Staff Training and

Security Awareness | Business Continuity Plan | Security Policies and Procedures • Addressing Risk with Selected Security Counter Measures: Personnel Security | Physical and Environmental Security | Network

Segmentation | Access Control: Account Administration, Authentication, and Authorization • Addressing Risk with Implementation Measures: Risk Management and Implementation | System Development and Maintenance |

Information and Document Management | Incident Planning and Response • Monitoring and Improving the CSMS: Compliance and Review | Improve and Maintain the CSMS

Includes ISA Standards: • ANSI/ISA-62443-1-1 (ANSI/ISA-99.00.01-2007) – Security for Industrial Automation and Control Systems Part 1: Terminology,

Concepts & Models • ANSI/ISA-62443-2-1 (ANSI/ISA-99.02.01-2009) – Security for Industrial Automation and Control Systems: Establishing an Industrial

Automation and Control Systems Security Program • ANSI/ISA-62443-3-3 – Security for Industrial Automation and Control Systems: System Security Requirements and Security Levels

If you wish to register offline, download the Training Registration Form, complete, and return to ISA with your payment. Not sure this particular course is for you? A pre-instructional survey is available for you to evaluate your level of understanding of the course material and to show you the types of questions you’ll be able to answer after completing the course. – See more at https://www.isa.org/templates/two-column.aspx?pageid=124388#sthash.ho0UKdTi.dpuf EVENT: March 16, 2016 LOCATION: Rochestown Park Hotel – See more at https://www.isa.org/store/products/?mssort=start_date%20asc&mssearch=ic32c#/f7950de84f620b29a577f8a4c0df62b3 $630 USD (€ 575) $520 USD (€ 475) for members

About the ISA Food & Pharmaceutical Division The Food and Pharmaceutical Industries Division (also known as FPID) is organized within the Industry and Sciences Department of ISA. The Food and Pharmaceutical Industries Division is the Division for sharing and understanding the latest technology for sensor, instrument, equipment, automation, computer-system, and software application for the Consumer Packaged Goods (CPG) and Pharmaceutical Supply Chains. The FPID represents a knowledge base of design, engineering, system, software, process automation, validation, quality, research, and scientific professionals. Share and enhance personal expertise for CPG product manufacturing and packaging, pharmaceutical R & D, clinical trials, and manufacturing of tablet formulations, parenteral and biotech products. Become involved in helping ISA provide global leadership at the FDA in the USA and other international regulatory bodies. In this capacity, you provide valuable knowledge and input on controversial issues regarding instrumentation, analysis automation, equipment and system validation, and testing for regulatory compliance. - See more at https://www.isa.org/participate-in-a-technical-division/food-and-pharmaceuticals-division/#sthash.OVU3tk1K.dpuf Join the 16,000 ISA Members who have already realized the value of technical division membership. FPID membership aligns your personal interests with your professional goals and allows you and your employer the opportunity to take full advantage of the technology, programs, developments, and special events we offer year-round. In addition, you now have the opportunity to share your experience, learn from your peers and receive exclusive benefits and privileges, including:

• Networking - A division representing a knowledge base of design, engineering, system, software, process automation, validation, quality, research, and scientific professionals who have the opportunity to network with other FPID industry leaders at other FPID sponsored events.

• Leadership - The opportunity to sharpen your leadership skills by helping to plan and conduct various FPID events.

• Events - Supporting ISA conferences and symposia by submitting industry papers, reviewing papers, and participating in session development.

• Knowledge - The opportunity to share and enhance personal expertise for CPG product manufacturing and packaging, pharmaceutical R & D, clinical trials, and manufacturing of tablet formulations, parenterals, and biotech products.

• Valuable Information Resource - In addition to the above, FPID membership supplies: o Two or three comprehensive industry newsletters per year o Access to the FPID website that provides industry technical papers, web seminars, and

a list serve industry peers. These benefits are designed to enhance your personal interests and professional goals. See more at https://www.isa.org/participate-in-a-technical-division/food-and-pharmaceuticals-division/#sthash.OVU3tk1K.dpuf

Symposium Notes

Symposium Notes

MAP m 14 15 March 2016 Suite,own tel, Cork rssl olutionse System Partners wer & Processcese Solutionstems on Ltd echnologies Control Engineering Tech Systems Ltdks Control & Automation ware tion Consultants

2016 Food and Pharmaceutical Symposium

Founded in 1945, the International Society of Automation is a leading, global, nonprofit organization that is setting the standard for automation by helping over 40,000 worldwide members and other professionals solve difficult technical problems, while enhancing their leadership and personal career capabilities. Based in Research Triangle Park, North Carolina, ISA develops standards; certifies industry professionals; provides education and training; publishes books and technical articles; and hosts conferences and exhibitions for automation professionals.

CONTACTS

Declan Lordan Symposium Chair Douglas Automation info@isa.ie +353-87-2510501

Rodney Jones ISA Staff Contact rjones@isa.org (919) 990-9418

Note: See symposium website for 2016 exhibitor & sponsorship opportunities

International Society of Automation 67 T.W. Alexander Drive PO Box 12277 Research Triangle Park, NC 27709 E-Mail: info@isa.org Telephone: (919) 549-8411 Fax: (919) 549-8288 www.isa.org

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