Pharmaceutical Cybersecurity.

The International Society of Automation (ISA) will be holding an invitation-only meeting of top pharmaceutical industry executives on 16 May 2017 to assess industrial cybersecurity challenges facing this automation industry sector and to examine strategies for solving them.

The meeting event, “Pharmaceutical Cybersecurity Convocation: A Critical Executive Dialogue,” will be held in conjunction with ISA’s Food & Pharmaceutical Industries Division (FPID) Symposium.

According to Patrick J. Gouhin, ISA Executive Director & CEO: “In this strategic conversation, we hope to educate each other to the concerns regarding threats and risk mitigation, and identify corporate challenges toward an ongoing interactive network. The dialogue will aim to focus on the collective interests/challenges of the industry as a whole, and what can be done to ensure a safe, secure, efficient and productive sector, as it relates to the future of automation and its impact on business for years to come.”

ISA has been at the vanguard of global initiatives to protect industrial automation and control systems (IACS) from potentially catastrophic industrial cyberattack through the development of its ISA99 (ISA/IEC 62443) series of IACS security standards.

Regarded as the world’s only consensus-based series of industrial security standards, ISA/IEC 62443 protects IACS through a lifecycle that integrates design, implementation, monitoring and continuous improvement.

As a flexible framework for addressing IACS security weaknesses across all key industry sectors, the ISA/IEC 62443 series are integral components of the US government’s current and future plans to combat industrial cyberattack.

“Pharmaceutical Cybersecurity Convocation: A Critical Executive Dialogue” The preliminary agenda, outlined below, features industrial cybersecurity experts and leaders from ISA as well as from government and industry groups. Welcome Introduction Steve Pflantz, 2017 ISA President Executive Overview Patrick J. Gouhin, ISA Executive Director & CEO Issues of National Security Adam Sedgewick (invited), National Institute for Standards and Technology (NIST) IACS and ISA/IEC 62443 standards Eric Cosman, ISA Executive Board & Co-Chair, ISA99 Committee Open Architecture Dennis Brandl and Jim Hietela (invited), The Open Group  Critical Challenges: A Panel Discussion Moderator: Patrick J. Gouhin, ISA Executive Director & CEO Panelists include: Eric Cosman, ISA Executive Board & Co-Chair, ISA99 Committee Dennis Brandl, The Open Group Doug Wylie (invited), SANS Institute Andy Chatcha (invited), ARC Advisory Group Closing & Continuing the Conversation Bill Joss, ISA Senior Business Development Manager

 #FPID17 #Pauto #ISAuto #Pharma

Food & Pharma returns to USA!

The 2016 FPID Conference was the first international ISA symposium held outside of North America. It was very well attended and the local section is extremely proud of its success.

This year, ISA’s Food and Pharmaceutical Industries Symposium, (FPID) returns to North America, to Boston, Massachusetts - 16–17 May 2017! The symposium will focus on how automation is used to address the impact of increased regulation, manufacturing costs, and security threats related to the food and beverage, pharmaceutical, and biotech industries.

A few slots may still be available for speakers to present on the latest trends, and provide case studies that demonstrate the effective integration and use of automation to solve these challenges.

Abstract deadline is 9 January 2017!

Abstract topics for consideration include:

Industrial Cybersecurity

Process Control and Pharmaceutical Instrumentation

Data Integrity

Alarm Management

Industrial Internet of Things (IIOT)

Usage of Cloud for Automation

Batch Management & MES

Wireless Application in Food, Pharma, and Biotech

Calibration Management

Process Optimization

Factory of the Future: Industry 4.0 and Smart Manufacturing

Serialization/Track and Trace

OEE, PAT, GAMP

Paperless Automation

Manufacturing Regulations

Project Case Studies

Flexible Manufacturing and Architecture

Implementation of ISA-related Standards

Click here to download the 2017 Call for Papers.

#FPID17 #PAuto #ISAuto

Contribution recognised!

During the recent AGM of the Ireland Section of ISA the part of Read-out in publicising the third ISA Food and Pharmaceutical Division Seminar (FPID2016) was acknowledged. The Food and Pharmaceutical Division of ISA is one of the most active in the Society.

Dave O'Brien (L) and Eoin Ó Riain

This was a held for the first time outside North America and was proclaimed as a great success with well over 200 attendees benefiting from the expert information shared over a period of two days.

The ISA Ireland section has made a substantial contribution to the ISA since 1977 providing officers for the international organisation over the years, Indeed currently there are two Section members serving, Billy Walsh and Brian Curtis. Indeed this year one of them, Brian Curtis, has been nominated for the position of President-Elect Secretary. This position is filled by election of the members and voting for this position, and other leadership positions will be announced later.

Dave O'Brien, who was Chairman of the FPID Seminar (and a future District 12 - EMEA - VP) made a presentation to Read-out's Eoin Ó Riain at the AGM. Eoin Ó Riain, himself a former ISA VP,  in turn thanked the ISA for this acknowledged and praised in turn the trojan work done by the Ireland Section members and hailed the international co-operation which led to this successful event.

 #FPID16 #ISAuto #Ireland

Food & Pharma symposium almost doubles in size!

ISA conducted its third annual Food and Pharmaceutical Industries Division (FPID) Symposium last week in Cork, Ireland. This year's event—first time held outside of North America—draws nearly twice as many attendees as previous year, says ISA in this account.  • Read-out's own account on this event is here: Food & Phramaceutical Futures. Nearly 240 professionals within the automation and control field and the pharmaceutical and food industries gathered last week in Cork, Ireland to explore solutions to automation challenges in food processing and drug manufacture and distribution. ISA President Jim Keaveney & Ireland Section President Alan Batemen at the Symposium The 2016 ISA Food and Pharmaceutical Industries Division (FPID) Symposium, held 14-15 March, outlined best-practice approaches in automation to leaders of pharmaceutical and food processing companies seeking to improve quality, safety, reliability, profitability, cost control and production throughput. The turnout nearly doubled the attendance of last year’s event, which was held in Philadelphia, (PA USA). This year’s technical program featured 40 technical presentations and the perspectives of 33 subject matter experts. Particular attention was given to how automation can help solve key, front-and-center challenges—such as meeting regulatory requirements, reducing manufacturing costs, and countering security threats—and the role of automation technology and innovation in addressing longer-term global dynamics and demands. “This was truly an internationally focused event because it tackled the significant issues and trends in automation affecting the food and pharmaceutical industries on a global scale,” emphasized André Michel, President of Efficient Plant, Inc., and the Director of ISA’s Food and Pharmaceutical Division. “The technical presentations and content honed in on the vital concerns of attendees and how they can be overcome.” Michel added that ISA’s Ireland Section played a key role in promoting the event locally and attracting a large base of attendees.  Billy Walsh, chair of ISA’s Assembly of Operational Department Vice Presidents and a member of the Society’s Executive Board, said the event brought together a wide range of global experts—across end user and vendor communities and from industry research and development—that were eager to "exchange leading-edge viewpoints and ideas.”  Conference sessions covered a wide range of essential topics, including: Serialization Track and Trace Data integrity Digitization Cybersecurity Automation/biotech Process optimization Automation to Survive – Industry 4.0 Equipment effectiveness Jim Keaveney, ISA President, was presented  with a shamrock by Cork Mayor, Claire Cullinane. The event was held just prior to Ireland's national day St Patrick's Day Alarm management Other highlights of the event included: Featured presentations by two visionary experts in automation and control: Paul McKenzie, Ph.D., Senior Vice President of Global Biologics Manufacturing & Technical Services at Biogen; and Peter Martin, Ph.D., Vice President and Fellow at Schneider Electric Company. Dr. McKenzie’s presentation, titled “Driving Change through Innovation and Standards,” discussed the importance of process and product innovation geared to customer value and standards-based thinking on product lifecycle management and partnership models. Dr. Martin’s presentation, titled “Innovation and a Future Perspective on Automation and Control,” investigated: the different levels of innovation; why industrial automation and control may be at an inflection point leading to inspirational innovation; and the prospects of performance improvements for food and pharmaceutical companies. A welcome address to attendees given by Cork County Mayor Councillor Claire Cullinane. A vendor exhibit featuring the products and services of 28 leading companies. Eleven sponsors and eight media partners supported the symposium. The on-site instruction of two high-value ISA courses:Introduction to the Management of Alarm Systems (IC39C) and Introduction to Industrial Automation Security and the ANSI/ISA-62443 Standards (IC32C) The opportunity to gain professional development hours (PDHs). ISA’s 2017 FPID Symposium is tentatively scheduled to take place in Boston, (MA USA) during March of next year. Symposium organizers are already recruiting volunteers, participants and speakers for the event. “Given the great success of this year’s event, many of the attendees, speakers and exhibitors I met with are very much looking forward to the 2017 symposium in Boston,” said Declan Lordan, Marketing and Sales Director at Douglas Control & Automation and a long-time ISA volunteer leader in Ireland. #FPID16 #ISAuto #PAuto

Alarms & automation Security.

The ISA International FPID Division Symposium, being held in Cork (IRL), will provide an outstanding opportunity to gain the latest updates, news, trends and projections for pharmaceutical and food processing companies seeking to address the impact of increased regulation, manufacturing costs, and security threats facing this industry.

FPID registrants will hear two renowned visionary keynote presenters: Peter Martin, Ph.D. and Paul McKenzie, Ph.D. Both speakers will present on the latest trends, and provide case studies which demonstrate the effective integration and use of automation to solve these challenges.

In addition there are two ISA short courses being held in conjunction with this year’s event. Thus registrants can make most of your valuable time at this premier event for FPID professionals by also registering for one of the two expert-developed ISA training courses. These courses can help enhance your FPID program development, implementation, compliance, and maintenance knowledge. In addition, by attending these courses, you will earn valuable CEUs and PDHs.

To add a registration for one of these courses to your FPID conference registration, contact ISA customer service at +1 919-549-8411 or visit here.

Introduction to the Management of Alarm Systems (IC39C) Nick Sands Date: 16 March 2016 Instructor: Nick Sands Course No.: IC39C 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 Includes ISA Standard: ANSI/ISA18.00.02, Management of Alarm Systems for the Process Industries To register or learn more, click here  or call +1 919-549-8411.

Introduction to Industrial Automation Security & the ANSI/ISA-62443 Stds (IC32C) Eric Cosman Date: 16 March 2016 Instructor: Eric Cosman Course No.: IC32C 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 course teaches you the basics of the ISA/IEC62443 standards and how these can be applied in typical factory or plant. You will be introduced to the terminology, concepts, and models, as well as the element of creating a cybersecurity management system. 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 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 • How IT and the plant floor are different and how they are the same • Current security standards and practices • Creating a security program • Risk analysis • Addressing risk with security policy, organization, and awareness • Addressing risk with selected security counter measures • Administration, authentication, and authorization • Addressing risk with implementation measures • Monitoring and improving the CSMS Includes ISA Standards: ANSI/ISA-99.00.01-2007, ANSI/ISA-TR99.00.01-20 ANSI/ISA-99.02.01-2009, and ANSI/ISA-62443-3-3 To register or learn more click here, or call +1 919-549-8411.

Date: 16th March 2016
Time: 8:00 a.m. – 4:00 p.m.
CEUs (PDHs): 0.7 (7)
Location:
Rochestown Park Hotel
Cork, Ireland

Registration*:
ISA Member: US$520 (€475.00)
Non-member: US$630 (€575.00) 

* Course registration is separate from and in addition to conference registration. You can choose to register for training or the conference only, or for both. To add registration for one of these courses to your existing conference registration, contact ISA customer service at +1 919-549-8411 or click here.

#PAuto #Training #FPID16 @ISA_Interchange

Seminar on building a case for calibration system.

The International Society of Automation (ISA) and its Premier Strategic Partner for calibration, Beamex, will co-host a free webinar 8 March 2016 on how to build a business case for a calibration system.

Dr Peter Martin

The webinar, which will be held from 12 p.m. to 1:30 p.m., Eastern Daylight Time, will feature three automation experts: Peter Martin, Ph.D., Vice President at Schneider Electric*; David Hunt, Power Generation Supervisor at Tucson Electric Power; and Alex Maxfield, Vice President at Beamex.

Building a calibration system business case is now a relevant and much-talked topic within industrial companies. Just like any other business investment, investment in calibration in general and more specifically to a particular calibration system must be economically justified. This webinar addresses and discusses both viewpoints: how an industrial company can justify an investment in calibration and the aspects to be considered when building a business case for a particular calibration system (e.g. financial, compliance, risk mitigation, system lifecycle). The webinar will also present a case story from the power generation industry.

“ISA is pleased to continue to collaborate with Beamex on these free webinars that educate our members and customers and others in the automation community on topics of significant interest and value,” says Jennifer Infantino Halsey, ISA's Director of Marketing & Communications. “Given the essential role calibration plays in modern process automation, it’s important to recognize the critical factors involved in developing a calibration system.”

“Simply put, this could be the most important calibration webinar of 2016, so you don’t want to miss it. The topic is very relevant and interesting among industrial companies and it is brought to you by leading industry influencers and experts,” says Greg Sumners, President of Beamex, Inc. (USA).

* Dr Peter Martin is scheduled to be a keynote speaker at the first ISA FPID Conference being held outside of North America in Cork, Ireland 14th-16th March 2016.

 @BeamexGlobal #ISAuto #FPID16 #PAuto

Major Food and Pharma event in Ireland looks exciting. #FPID16 #PAuto #ISAuto

Attendance at a previous FPID Symposium

We reported last year that the 3rd International Society of Automation's Food and Pharmaceutical Symposium (#FPID16) was scheduled to be held in Ireland in March 2016.  It is the first time that the event has been staged outside of North America and already a formidable line-up of speakers have agreed to present. This is the principle event of the ISA's Food & Pharmaceutical Division.

One of the keynote speakers is Dr Peter G. Martin, the world-renowned and acclaimed expert in automation and control, having held executive and technical positions in engineering, product and strategic planning, marketing and training throughout his career and is a Senior. He is VP and Edison Master with Schneider Electric Company.Dr Martin is a recipient of the ISA Life Achievement Award, and has been named as one of the 50 most influential innovators of all time in instrumentation and controls. He is also an ISA Fellow.
An invigorating and knowledgeable speaker, he will address the topic of Innovation and a Future Perspective on Automation and Control. 

Dr Paul McKenzie, the second keynote speaker is 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 Research & Development Leadership Team, Paul is a trusted leader, responsible for R&D’s global strategy, portfolio prioritization and execution, resource strategy & development, and advancement of R&D talent.
Dr McKenzie will adress Using Data to Optimize the Product Life Cycle.

Other speakers, users and developers, and there are around forty listed, will address topic such as (to name a few):

• Benefits of Serialization Track & Trace; 
• Industry Engagement and Solutions; 
• Preparing your laboratory for a data integrity audit; 
• The Application of Industrial Internet of Things (IoT) in the form of The Connected Enterprise;
• Cybersecurity; 
• Alarm Management; and many others.

The International President of ISA, Mr Jim Keaveney will also be in attendance and it is hoped to have a member of the Government in attendance though of course pending the result of the Irish General Election scheduled for February.

 #FPID16 #PAuto #ISAuto

Call for papers for International Food & Pharma event.

The ISA FPID 2016 is organised by the International Society of Automation (ISA).

The ISA’s international Food and Pharmaceutical symposium is being held in Ireland in March 2016, and its first time to be held outside of North America. The symposium will bring together experts, suppliers, and end users in a two-day symposium of presentations and panel discussions.

The first call for papers has been issued with a deadline of 30th November 2015.

The symposium will focus on how Automation is used to address the impact of increased regulation, 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.

The table below shows suggestions for topics but prospective presentations should not limit themselves to these.

Suggested Topics • Cyber Security • ISA Standards • Sustainable Processing • Process Optimisation • Data Integrity • Serialization / Track and Trace • Alarm Management • OEE, PAT, GAMP • Industrial Internet of Things • Energy/ Waste Management • Usage of Cloud for Automation • Process Control • Instrumentation: Calibration, Wireless • Paperless Automation • Batch Management & MES • Manufacturing Regulations

Use the hastag #FPID16 on twitter

Important Food and Pharma event scheduled for Ireland in 2016.

160 professionals within the automation and control field and the pharmaceuticals and food industries will gather in Cork (IRL) next March to explore solutions to the critical challenges relating to automation in food processing and drug manufacture and distribution.

Book Now

The third annual ISA Food and Pharmaceutical Industries Division (FPID) Symposium will deliver best practice insights and approaches to leaders of pharmaceutical and food processing companies seeking to improve quality, safety, reliability, profitability, cost control and production throughput. The meeting’s content-rich technical program will highlight the latest trends, innovations, strategies and techniques in process automation through expert-­led technical sessions and numerous roundtable discussions. A spectrum of technical sessions will cover key topics and issues of importance. The first such event was held in North Carolina (2014) the second in Philadelphia in 2015, both in the USA.

The first paper call has been issued and the deadline is 30th November 2015.

This will be the first of these internationally focused ISA symposia to be held outside of continental North America.

The local ISA Section is heavily involved in the organising of the event and has extensive experience in the organising of national events such as the Technology Modernisation seminar earlier this year. Updates will be highlighted and contact details will be listed on the symposium website.

There is also a limited amount of space for exhibitors and Carol Schafer is the person to contact to insure your company is in the heart of things.

Sunset  over Cork City

#FPID16 #PAuto #ISAuto

Food and pharma symposium!

The conference program for the ISA 2014 Food and Pharmaceuticals Industries Division (FPID) Symposium will feature some of the world’s most accomplished experts in serialization and automation who will speak on the pressing issues affecting food and drug manufacturers and distributors.

2014 ISA FPID Symposium, which will be held 5-6 March 2014 at ISA headquarters in North Carolina (USA), will learn—directly from these industry leaders—how to respond to emerging serialization requirements that are driving major changes in food and pharmaceuticals distribution and calling for highly coordinated strategies that incorporate automation, supply chain management, and information analysis and security.

“We are immensely pleased to have assembled such an outstanding lineup of speakers, experts and presentations at this valuable industry event,” reports  Dennis Brandl, President of BR&L Consulting, Inc., co-chair of the 2014 FPID Symposium. “The challenges facing the food and pharmaceuticals industries are serious and they require a serious examination of the issues. Recent legislation and incidents of contamination and tampering have raised the importance of automation to reduce errors and implement enhanced serialization controls to improve tracking and tracing throughout distribution channels.

“This symposium will provide the essential insights and recommendations—relating to technology, systems, production, logistics, process control, validation, traceability, data access and analysis, cybersecurity and other critical areas—that food and pharmaceuticals manufacturers and distributors need to improve patient safety and reduce operating risks.”

Among the prominent experts and incisive presentations scheduled on the 2014 FPID conference agenda are:

Attendees of the

• Peter Martin, Ph.D., vice president of business value solutions for the Software and Industrial Automation division of Invensys, presenting “Applying Control Theory to the Real-Time Value Chain”
• Janice Abel, group analysis and principal consultant at ARC Advisory Group, presenting “Getting Smarter with Big Data, Analytics and Enterprise Manufacturing Intelligence”
• Bryan Singer, principal investigator, Industrial Network/Critical Infrastructure Cybersecurity at Kenexis Security Corporation, presenting “Building on Device Vulnerabilities: Attack Mode for ICS”
• Marcus Massingham, I.Eng, MIET, director, Automation/IT at GlaxoSmithkline, presenting “Serialization: An Enterprise Perspective”
• Wendy Haines, Ph.D., validation specialist at Mangan Biopharm; and Amy Lineberry, CPIP, validation engineer at Mangan Biopharm; presenting “Lifecycle Approach to Serialization Process Qualification”
• Baha Korkmaz, PMP, senior vice president, North America at Enterprise System Partners, presenting “Serialization: A Business Perspective”
• Dennis Brandl, president at BR&L Consulting, presenting “Business-to-Shop Floor Integration: The Critical Link in Serialization”
• Jorge Rodriquez, PE, president and CEO of PACIV, presenting “Harmonization of C&Q and CSV Initiatives”
• Desmond Savage, managing director at ATS Applied Tech Systems, presenting “Food Safety and Traceability: MES as an Enabler”
• Dave Adler, PE, automation project management, planning and workforce development expert at Brillig System, and Raymond Teaster, owner and director at Brillig System, presenting “Successfully Managing Automation Projects”
• Tim Mathany, president of ECS Solutions, presenting “ISA-88 Model-Based Control in the Food Industry”
• Mike Baldauff, engineer at FUJIFILM Diosynth Biotechnologies, presenting “Evaluating Virtualization of a Control System for Use in Production”
• Lee White, project engineer at Avid Solutions, presenting ”Automation System Design Practices”
• Adam Fermier, scientific director at Johnson & Johnson, presenting “Transforming Data into Information: An Engineering Approach”
• Ron Guido, retired vice president of Global Brand Protection and Supply Chain Integrity at Johnson & Johnson, presenting “Confessions of a Counterfeiter”
• Bob Lenich, director of Global Syncade Sales at Emerson Process Management, presenting on Manufacturing Execution Systems (MES)
• Greg Stromberg, process analytics manager at Biogen IDEC, presenting “The Benefits of Modern Data Analysis Techniques in Process Development and Production Scale Cell Culture Processes”
• John Hamel, regional manager at Parsec Automation, and Steve Monaghan, PE, operations manager at Applied Control Engineering, presenting “Why Overall Equipment Effectiveness Isn’t Enough”
• Bill Minaeff, sales manager at Laetus, presenting “Serialization in the Pharma Industries”
• Marc Blekkink, managing director at Ninety-Five, and Guido Rijcken, managing director at Inxites Americas, presenting “ISA-95 Based Data Repository in a Serialization System Landscape”

In addition to benefiting from the stellar conference sessions, 2014 FPID Symposium attendees will tour a local plant to examine specific automation processes in practice.