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. 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 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 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.

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:

• 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 Whiye 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

Symposium - Day 1 Morning Sessions

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

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.

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:

• 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 Whiye 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

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.

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.

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.

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

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

CS on Delivery of Large Scale Vaccines

Project in Belgium : Martin McAree

IT/Automation for a Bio-Pharma Facility in a

Green Field Site : Alan Shefflin

Plan, Design, Build & Run for Systems in

Biotech Facility: 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

IT/Automation for a Bio-Pharma Facility in a Green Field Site: 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

SPEAKERS BIO’S

Alan Bateman

Janssen Biologics

Senior Execution

Systems Manager

Senior Execution Systems Manager with a

proven track record of leading a variety of

automation and multi-discipline programs.

18 years’ experience in the Life Sciences

Industry including 16 years in Automation

in the Small Molecule and Large Molecule

API Manufacturing Industry. Successful

leader, experienced in leading and

developing teams of professionals.

President of the ISA Ireland Section

Kim Van Camp

Product Marketing

/ Manager

Emerson Process

Management Kim Van Camp is the Emerson Process

Management Marketing Product Manager

for Alarm Management. He joined

Emerson in 1976 and has held senior

assignments in Manufacturing,

Technology, Field Service, Customer

Service and Marketing. Kim is a voting

member of the ISA-18.2 committee

Management of Alarm Systems for the

Process Industries.

Martin Corkery

Regional Manager,

Cork

Enterprise Ireland

Martin Corkery has been involved in a

business development advisory role in the

Cork region for the last 20 years. Before

joining Enterprise Ireland (EI) in 2002 he

worked with South Cork Enterprise. Since

joining Enterprise Ireland, Martin has

advised and supported a significant

number of High Potential Start-Ups across

multiple sectors Currently Martin leads up

the Cork office and works with his team

focusing on the key strategic pillars of

start, scale and innovate where he actively

engages on strategic initiatives with

industry, academia, and other key public

and private organisations within the

region. Martin and his team also have a

major role in the implementation of the

South West Region’s Action Plan for Jobs

Strategy.

Eric C. Cosman

Principal

Consultant

OIT Concepts LLC Eric C. Cosman provides consulting and

advisory services in the management of

information technology solutions in

Operations and Engineering. He has

contributed to various standards

committees, industry focus groups, and

advisory panels. He is a past vice president

of standards and practices at ISA and is

currently a member of the ISA Executive

Board and co-chair of the ISA99

committee on industrial control systems

security.

William Dugary

ACE

Senior Business

Development

Manager Senior Business Development Manager &

Automation Consultant with Applied

Control Engineering (ACE). Having

previously worked with ABB, Bailey

Controls and Johnston Controls,

Bill was Chair of the organizing committee

for the successful 2015 ISA Food &

Pharmaceutical Division Symposium which

was held in Philadelphia on Feb. 10th &

11th 2015 in cooperation with the 25th

Annual Exhibitors night of the Delaware

Valley Chapter ISPE,

Siobhan Duggan

Director of

Innovation and

Healthcare

GS1 Ireland

Siobhan is currently working on a number

of projects to promote the adoption of

GS1 Standards for healthcare in Ireland.

These include projects regarding a

National Product Catalogue for Ireland to

include GS1 coding and standardization of

data from suppliers which facilitate e-

commerce and many other applications in

healthcare.

Cormac Garvey

CTO,

HAL Software

Cormac graduated from UCD Faculty of

Engineering in 1992 and is a 24 year

veteran of both industrial automation and

IT design across multiple industries. He is

an advocate of rapid prototyping and

standardisation concepts in the Agile

design environment and believes they

have a key role in addressing inherent

challenges in Industry 4.0 level system

integration. He is the CTO of HAL

Software.

Phil George

Solution Architect

Rockwell

Automation For the last 27 years Phil has been working

with automation and information

solutions in many different vertical

sectors.

Currently he’s using this experience to

help businesses become more efficient by

adopting Industrial IoT (IIoT). He majors

on practical execution, working with many

blue chip and SME customers making

unprecedented advances by adopting IIoT.

He manages an engineering team to

blueprint “The Connected Enterprise.”

Robert Jones

MD

Vision ID

Robert Jones has over 22 years’

experience of working in the AutoID

industry, concentrating on Barcoding,

Mobile Computing and Radio Frequency

Identification (RFID). Of these 22 years,

Robert started and managed VisionID for

the last 16 years. VisionID is a 100% Irish

owned company that specialises in the

provision of Traceability and Mobile

Enablement solutions.

SPEAKERS BIO’S

Jim Keaveney

ISA President –

2016

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.

Jim is the Northeast Regional Manager

and Key Account Director (Merck) at

Emerson Process Management. He brings

a strong track record in automation

technologies sales and marketing and

business planning to his role as Society

President.

Peter Koop

Arvato Systems

Marketing Mgr

Overall project manager with Arvato

Systems for the construction of a central

technical platform for anti-counterfeiting

in the German pharmaceutical market.

Arvato Systems specializes in IT Solutions

for Digital Transformation with over 25

locations across the globe. They are one of

the three firms selected by the EMVO

(European Medicines Verification

Organisation) to provide the data hubs

underpinning the proposed EU medicines

tracking scheme.

Jim Labonty

Pfizer Biotech

Global Engineer

Jim LaBonty works for Pfizer Global

Engineering – Process Automation

overseeing from an automation

perspective Pfizer Biotech and Aseptic

manufacturing sites across the globe. Prior

to joining Pfizer, Jim worked for Rockwell

Automation in their Life Sciences project

team based out of Cleveland, Ohio.

However, most of Jim’s automation, IT

and control systems career was spent at

Eastman Kodak in Rochester, New York;

where he held positions of ever increasing

leadership responsibility as a global

Control Systems Project Engineer,

Maintenance Team Lead, site Capital

Portfolio Manager and IT & Automation

site lead for Color Film Operations. Jim has

35 years of industry experience having

worked with a plethora of control systems

and information systems as well as

leveraging advanced control optimization

strategies."

Barry Lawlor

Johnston &

Johnstown Ltd

Director of

execution systems Barry Lawlor is the Director of Execution

System for the Liquid Creams &

Transdermals platforms at Johnson &

Johnson where he is responsible for

leading a global team supporting the

liquids, creams and transdermal sites

across the network in optimizing their

data and knowledge management through

system standardization.

Barry joined Johnson & Johnson in 2005,

as an Automation Engineer, where he

worked in partnership with global

engineering to deliver the control system

infrastructure and support mechanisms

for the Janssen (formerly Centocor)

Greenfield start-up. In 2009 he was

appointed as the Project Manager & IT

Lead (Biologics) for the development &

implementation of an MES core for API

manufacturing. In 2011 Barry was

appointed as Automation Technical

Services Lead for Janssen Biologics and

later appointed to the role of Director of

Manufacturing Systems for Janssen Supply

Chain Ireland with responsibility for the

development, support and maintenance

of Manufacturing Systems (Automation,

MES and the associated interfaces).

Prior to joining J&J, Barry worked in

various Automation roles with Pfizer,

Emerson Process Management and

Douglas Electronics.

Dr. Andrew Lynch

ICMR

Chief Innovation &

Network Officer

Andrew Lynch is the Chief Innovation &

Network Officer with Advanced

Manufacturing Ireland, the family of

ICMR, i2e2 and Irish Manufacturing

Research. In this role Andrew is

responsible for the development of

innovative industrial research proposals

and the smooth integration of companies

into the industrial networks.

Andrew has worked as a senior manager,

owner manager and business consultant

to manufacturing companies for over 20

years in sectors as diverse as

pharmaceuticals, plastics, agri-business,

health & safety, transport, medical and

construction. He has worked extensively

in project management, grant

management (national/EU) and research

project proposals. Andrew holds a Degree

in Biology, a Masters in Analytical

Chemistry and a PhD in Engineering and is

the author of several academic articles

published in scientific and business

literature.

Frank Madden

Crest Solutions

CEO

Frank Madden is an expert in the field of

vision engineering and it is against this

background that he founded Crest

Solutions in 1998. Frank has a background

steeped in manufacturing for the

electronics industry in Ireland and

internationally. Prior to founding Crest

Solutions, he played an integral role in the

team responsible for manufacturing at

Apple Computers in Ireland. He also

worked in an engineering and

manufacturing capacity at Concurrent Ltd.

and Alps Electric. Frank is a graduate of

both the Cork and Sligo Institutes of

Technology where he studied Electronic

SPEAKERS BIO’S

Engineering. In 2015 Frank was a finalist in

the EY Entrepreneur of the Year Awards, a

programme which recognises outstanding

business leadership in Ireland.

Peter Martin

Invensys plc

Vice President

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.

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.

Martin McAree

PM Group

Principle Engineer

Associate Director

Martin is a principle automation engineer

and associate director with the PM Group.

Martin worked with PM for 31 years and

in that time has led the automation design

and delivery on all of PM’s large scale

international biopharma projects and is

currently automation project manager on

a large scale antibiotics facility in the UK.

Seamus McGrath

Novartis Ringaskiddy

Head of Automation

and IT

Seamus has been Head of Automation and

IT at NRL for over three years and the

Automation Systems Manager for well

over a dozen years. Prior to that he had

Project Manager and Engineering

Experience with several companies

including Granite Services, ABB, ProsCon

and GE Energy.

Presently he is responsible for the

provision of applications and systems

along with IT infrastructure that support

the business and manufacturing

operations including Automation Systems

to cover Laboratory Systems, Business

Systems and IT Infrastructure. His

specialties include IT and Automation

Lifecycle Management, Vendor support

strategy and negotiation, Systems Disaster

Recovery and Business continuity,

Supporting global strategy for Automation

systems, Manufacturing Information

Systems expertise, Project Management

and execution, Leading Internal Best

Practice Network, MES implementation,

relationship management both customers

and stakeholders

Paul McKenzie

Biogen

Senior Vice

President

Paul McKenzie is the Senior Vice President

for Global Biologics Manufacturing &

Technical Operations at Biogen, recently

joining in early 2016. 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 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. 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.

Arjan Meijer

Hudson Cybertec

Technology Lead

Arjan is a seasoned Security Consultant,

specialized in Cyber Security for the

Operational Technology (OT) domain.

Throughout his career, Arjan has had a

strong focus on Network Security and

Cyber Security Management for the OT

domain. Arjan is Subject Matter Expert

and Certified ISA trainer for ISA/IEC 62443.

SPEAKERS BIO’S

Stephen P.

Monaghan

Applied Control

Engineering, Inc

Vice President Steve Monaghan is Regional Operations

Manager and Vice President of Applied

Control Engineering, Inc. (ACE), a leader in

providing innovative, cost effective

solutions for process automation and

control system challenges. ACE has seven

(7) offices in the US and provides services

around the globe.

Steve is a registered professional engineer

based at ACE’s Delaware Valley office in

Newark, Delaware, USA. For nearly 19

years Steve has been executing process

control projects for mostly the

pharmaceutical and specialty chemical

industries. Since 2003, Steve has been

designing and implementing real-time

performance management systems,

primarily on pharmaceutical packaging

lines and solid oral dosage production

equipment. Steve has a BS in Chemical

Engineering from the University of

Delaware.

Alan Norbury

Siemens

Central Technology

Officer

Alan Norbury is the Central Technology

Officer for Siemens industrial activities - a

leading global supplier of industrial plant

and software, manufacturing automation

and drive technologies to industrial

customers across the UK and Ireland, and

dedicates his time to developing leading

technology innovation which seeks to

benefit Siemens UK manufacturing

facilities and also Siemens industrial

customers. Alan started his career in

Siemens in 1978.

Emmett O’Connor

TQS Integration

Director of

Software

Development Emmett has over 15 years’ experience in

the Process and Regulated industries with

a vast array of roles varying Data Analyst

to Software Architect. In the past number

of years he has led TQS Software

Development Arm, developing software

platforms to meet the company’s array of

customer’s needs.

Eamonn O’Mathuna

Enterprise System

Partners

Mfg Systems

Consultant Eamonn has over 26 years’ experience as

a manufacturing systems expert in Big

Pharma with particular expertise in MES,

Automation and Serialization. He has

provided technical expertise to supply

chain serialization projects in several Big

Pharma manufacturing sites since joining

ESP in 2012. Prior to this, he was technical

lead for a site serialization rollout with a

multinational biopharma company.

Marc O’Regan

EMC

CTO Chief Technology Officer at EMC Ireland.

Marc began his career at Dell where he

spent sixteen and a half years specializing

in Technology domains including Cloud,

Data Analytics and High Performance

Computing. During his time at Dell, Marc

successfully led the Compute Specialist

Practice for Dell Ireland, working with

Academia and industry to design, develop

& deploy compute and Cloud solutions,

while also notably contributing to Public

Cloud build outs including Microsoft Azure

and Amazon Web Services. He then

moved to EMC in November 2014 where

he currently leads the Technology vision

for the company’s operations in Ireland.

As CTO for EMC, Marc is responsible for

connecting EMC R&D with the EMC field

organization, its partners and its

customers, helping to change the way

businesses view and manage their

business services and technology assets.

As part of EMC’s CTO Office, Marc helps

drive the EMC technology vision, and cross

company technology strategy. Marc is a

recognized leader within the Cloud and

Grid communities, and within industry is a

regular keynote speaker and contributor

of articles on the subjects of Cloud,

Analytics, IoT and HPC.

Marc is a graduate of Trinity College

Dublin and lives with his wife and two girls

in Wicklow.

Predrag Šajinović

Applied Tech Systems Ltd.

MES Project Manager

Predrag is qualified with a Masters of

Science degree in Electrical engineering

(TU Delft). Since 2003, Predrag has been

involved in several MI (Manufacturing

Intelligence) projects for aerospace and

car manufacturers in UK and USA. From

2008 new MES projects were started for

several Food and Beverage customers.

During the period of several years,

Predrag has evolved to a successful MES

project manager.

Predrag’s certificates: Prince II, PMI ACP

(Agile Certified Practitioner) and

Certificate of Competency for MES/MOM

Methodologies

Nicholas P Sands

DuPont

Manufacturing

Technology Fellow

Nick is a Technology Fellow and Global

Alarm Management Leader for DuPont.

He is an ISA Fellow, Co-chair of Standards

& Practices committee 18 working on

Alarm Management and secretary of the

IEC committee for IEC62682. He is a

Certified Automation Professional with a

BS in Chemical Engineering from Virginia

Tech.

Desmond Savage

MESA EMEA

Board Member

Desmond is an MOM Consultant with ATS

Applied Tech Systems Ltd. Ireland. He has

been working in the area of MOM for over

15 years as a consultant, manufacturing

engineer and validation specialist. Since

2004 focus has been on promoting and

deploying MOM solutions within the Life

Science industry i.e. medical device and

pharmaceuticals. Desmond is the

SPEAKERS BIO’S

chairperson for MESA Ireland and in June

2011 completed the Certificate of

Competency for MES/MOM

Methodologies given by MESA

International. Desmond is qualified with a

Masters in Advanced Manufacturing

Technology (1999) from the University of

Limerick, Ireland.

Alan Shefflin

BMS

IT & Automation

Director

Alan is the Director of Automation and IT

at BMS’s new Large Scale Cell Culture

Biologics facility in Dublin with

responsibility for operational support of

the current and future facilities and

delivery of all Automation and IT project

scope. He has over 20 years’ experience in

Automation and IT.

Dr Peter Iles-Smith

MES Technical

Director

GlaxoSmithKline plc

/ UK

Peter is currently Technical Director for

Manufacturing Execution Systems with

GlaxoSmithKline and is responsible for the

definition, design, development and

implementation of MES within GSK’s

manufacturing organization. Prior to

that, Peter was responsible for GSK’s

primary supply (bulk active) automation

centre of excellence, covering process

control, instrumentation and allied

systems. Before joining GSK, Peter held a

number of consulting and engineering

positions. Peter holds a BSc and PhD in

Chemical Engineering from Leeds

University and is the co-author of a

number of books on project management.

Kevin Starr

ABB Process

Automation Division

Kevin has worked for ABB for nearly 30

years. His expertise is utilizing automation

equipment to improve quality,

production, and reduce the cost to

produce. He has been in the forefront of

ABB’s Advanced Services development

and delivery. He holds several patents

related to products that convert data into

information such that failures can be

reduced or illuminated all together. He

holds a Master’s Degree in Electrical

Engineering and is currently featured in

ABB’s new YouTube PID loop tuning video

series. His book “Single Loop Control

Methods” is rapidly becoming the go to

guide for tuning fundamentals. Kevin has

traveled the world teaching, developing,

and directing proactive service solutions.

He is currently ABB’s Global Director of

Advanced Services for Process

Automation.

Arthur Stone

OEEsystems

International

CEO

Arthur Stone is CEO of OEEsystems

International, a leading supplier of

Manufacturing Intelligence and

Performance Management software

solutions, used by the world’s leading

progressive manufacturing companies as

their preferred application for managing

real-time operational performance

improvement.

OEEsystems work with global

manufacturing companies to improve

competitiveness, increase capacity,

reduce costs and deliver business

performance excellence.

With over 25 years´ experience in Senior

Engineering, Operations and Technology

Management roles with international

manufacturing companies in Ireland and

the US, and an Engineering Degree from

University College Cork, Arthur has driven

several Lean Manufacturing and Six Sigma

initiatives in high-volume and high-

technology manufacturing environments.

Joe Whyte

Rockwell Automation

Global Serialization

Lead

Joe is a 26 year Life Sciences & CPG

Industry sales professional. Career

highlights include regional, national and

global sales and sales management roles,

and periods as a digital automation

technology entrepreneur. Technical

expertise includes machine and process

automation, robotics, packaging, vision, IT,

data management, information systems,

plant and supply chain optimization

Andrew Whytock

Siemens AG

Pharma Business

and Account

Development Andrew works in the Siemens Pharma

Competence Center in Karlsruhe,

Germany where he has global

responsibility for MES business

development. He provides technical and

commercial expertise in presenting,

demonstrating and providing

understanding on the benefits of

paperless manufacturing for customers in

their transition towards the digital factory.

Garry Wright

Agilent

European Laboratory

Compliance Specialist Presenter Biography: (50 words

Maximum) 20 years of Analytical

Chemistry experience within a GMP

Pharma CMO / CRO that was MHRA / FDA

approved. Special interests include

equipment qualification / management,

GMP training and regulatory auditing.

Joined Agilent in September 2015 as their

European Laboratory Compliance

Specialist to provide compliance

consulting to their customer base.

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

MAP

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

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