Regulator Keynote: Meeting USDA Regulatory Requirements in Your Operation’s Processes

How should you prepare and respond to Food Safety Assessments and Notices of Intended Enforcement? Understanding what USDA inspections...

Push Button Manufacturing: The Future of Making Things

The nature of work is changing How can we remove the constraints on design that traditional manufacturing processes impose?...

Regulator Keynote: Progress, Updates, and What Comes Next

FSMA continues to change the way the food industry works. How are things progressing, and where do we still...

Building a CI Culture in LEGO

Business Services Organization – A new adventure Joining the LEGO Family – onboarding and developing Building our BSO Management...

FSMA and Beyond: Documentation and Records Management as a Food Manufacturing Best Practice

FDA expectations for FSMA documentation compliance Best practices in developing Food Safety Plans and Food Defense Plans Organizing and...
Regulator Keynote: Meeting USDA Regulatory Requirements in Your Operation’s Processes
Push Button Manufacturing: The Future of Making Things
Regulator Keynote: Progress, Updates, and What Comes Next
Building a CI Culture in LEGO
FSMA and Beyond: Documentation and Records Management as a Food Manufacturing Best Practice
Regulator Keynote: Meeting USDA Regulatory Requirements in Your Operation’s Processes

Regulator Keynote: Meeting USDA Regulatory Requirements in Your Operation’s Processes

  • How should you prepare and respond to Food Safety Assessments and Notices of Intended Enforcement?
  • Understanding what USDA inspections are looking for when you conduct your own internal inspections
  • Offering key steps and best practices to improve your validation programs to align with USDA expectations
  • Illustrating what the extra mile looks like when we talk about commitment to public health, eliminating foodborne illnesses from the supply chain, and conducting effective product recalls

Carmen Rottenberg
Acting Deputy Under Secretary of Food Safety

Carmen Rottenberg was appointed Acting Deputy Under Secretary for the U.S. Department of Agriculture’s Office for Food Safety in August 2017. In this position, Ms. Rottenberg oversees development, implementation and enforcement of all of FSIS’ regulations, policies and programs. This appointment follows nearly six years in leadership roles in the Food Safety and Inspection Service’s (FSIS’) Office of the Administrator, including serving as the Chief of Staff, the Chief Operating Officer and, most recently, the Deputy Administrator.

In those leadership roles, Ms. Rottenberg executed a budget of over $1 billion, prioritizing resources and resolving disputes, advancing the Agency’s vision and goals, and leading innovative solutions to challenges in FSIS. She has spearheaded strategic planning at FSIS and implemented numerous initiatives to strategically move the agency forward. She implemented two major reorganizations leading to a more streamlined, efficient Agency better positioned to carry out its food safety mission. Through her leadership and oversight, an early governance process matured into an established systematic approach to agency decision-making, resulting in more deliberative, science-based decisions that consider enterprise-wide risks and benefits. Ms. Rottenberg’s vision led to the very successful i-Impact initiative which has increased the awareness of and engagement in FSIS’ public health mission by the more than 9,000 employees throughout the Agency.

Ms. Rottenberg joined FSIS as an Equal Employment Opportunity Specialist in 2007, and went on to become the Deputy Director of the Civil Rights Staff. Conducting training and working with FSIS employees from every program area and location while in those positions provided Ms. Rottenberg with a broad Agency perspective.

Ms. Rottenberg began her federal government career in the Federal Trade Commission’s Office of General Counsel, and prior to joining FSIS, Ms. Rottenberg was a law clerk at a small law firm in Fairfax, VA. Ms. Rottenberg holds a B.A. in Political Science and Philosophy from Hope College in Holland, MI and a JD degree from American University’s Washington College of Law.

Push Button Manufacturing: The Future of Making Things

Push Button Manufacturing: The Future of Making Things

  • The nature of work is changing
  • How can we remove the constraints on design that traditional manufacturing processes impose?
  • What are the major catalysts for disruption that we are seeing?
  • There is a convergence of new technologies in manufacturing and our goal is to make these available to everyone
  • Our prediction: “As designed” will become “as built” with the push of a button

At the 2018 edition of the North American Manufacturing Excellence Summit, Greg Fallon, Autodesk’s VP of Generative Design and Manufacturing Products, gave a breakfast briefing on Push Button Manufacturing. Afterwards he sat down for a follow up interview on this important new trend.

The full transcript of the interview is below, or you can download a PDF version.

You gave a talk today, a breakfast briefing. What was the subject of your presentation?

The briefing this morning was about our vision for Push Button Manufacturing.

Push Button Manufacturing is a simplified version of where we see manufacturing going in the future. The simplified analogy that we use —and I don’t mean this to be insulting to manufacturers because it is very simplified— but if you think back to the early days of desktop printing in the 80s and 90s the idea is that you would design a document, you would essentially write a document that you would see on your screen, and then you would go to print it and what came out on the printer was often not what you had in mind.

In a way that’s a nice metaphor or analogy for manufacturing, because it’s very hard to make what you’re manufacturing look like the design intent, and that’s the problem that we’re trying to solve.

It’s how do you automate different steps in the process so that what comes out of the manufacturing line matches what the design looks like without a lot of work going on in between.

In the past five years or so, Additive Manufacturing has grown into its own and matured. It is now being used in real world applications. How does that fit into the larger topic of Push Button Manufacturing?

It’s perfect because Additive Manufacturing gives the end user a lot of flexibility. You can customize every design and you can go from design to print much faster than traditional methods, like machining where you have to do very complex tool pathing and understanding the tools you’re working on and the tools you’re working with.

Whereas, Additive Manufacturing gives you a ton of flexibility. You can print a shoe one minute and an engine block later that day with a lot of changes.

There’s also tremendous change in the types of designs that you can print versus designs that you can say machine or cast. Printing gives you access to geometric complexity that was not available before.

An example I like to talk about is the redesign of an F1 cylinder head that we worked on with another company. To think about how Additive Manufacturing would change that cylinder head, we came up with a bunch of different design changes and manufacturing changes.
Traditionally the cylinder heads are cast and machined, so changing that to Additive Manufacturing changes that particular paradigm. Once you’re 3D printing a type of cylinder head, you don’t have to worry about all the excess material that exists in the original cylinder head, so you can use things like lattices to reduce the volume of the cylinder head.

You have a lot less excess or unused material. The whole concept of waste is very different with 3D printing. The amount of waste material might be 5% of what you would have with another method.

Once you start to do things like latticing the design, you get things like weight reduction inherently in the design. In this case, this is important to a racecar.

In addition to that, you get things like enhanced heat transfer. Because you’re using these lattices, the amount of surface area on the engine available to cool it goes up by many orders of magnitude and that allows you to get more heat out of the engine, which allows you to operate at higher temperatures and pressures, which improves the performance of the engine overall.

So, there’s this avalanche of benefits that comes out from simply changing the means of production.

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Regulator Keynote: Progress, Updates, and What Comes Next

Regulator Keynote: Progress, Updates, and What Comes Next

  • FSMA continues to change the way the food industry works. How are things progressing, and where do we still need to go?
  • How are regulators working with industry to ensure an orderly and effective rollout of new initiatives and standards?
  • Discussing metrics and timelines for how our ongoing projects and programs impact public safety
  • Updating information on new policies, priorities, and guidelines
  • Reviewing the most frequently asked questions by quality and compliance professionals

Joann Givens
Food and Feed Program Director (HAF-W)
Food and Drug Administration

Ms. Joann M. Givens serves as Office of Regulatory Affairs’ Human and Animal Food Program Director; HAF-West. In this leadership position, Joann oversees the human and animal food program work plan, accomplishments, implementation strategies of FSMA, program alignment advancement and collaborates with the Center of Food Safety and Applied Nutrition (CFSAN) and Center of Veterinary Medicine (CVM), ORA components and external stakeholders. Prior to serving in this position, Joann served as the Acting Regional Director of the Central Region for several years, Deputy Regional Director in the Central Region and District Director in Detroit District. Joann is a graduate of Berkeley College, Little Falls, NJ and also majored in biology at Kean University, Union, NJ. She is the recipient of numerous awards and a member of numerous professional organizations.

Building a CI Culture in LEGO

Building a CI Culture in LEGO

  • Business Services Organization – A new adventure
  • Joining the LEGO Family – onboarding and developing
  • Building our BSO Management System – Cascaded Strategy & Accountability
  • Continuously Improving – The LEGO way…

Peter Evans
LCI Director

Peter Evans was born in 1955. He joined the LEGO in February 2016

The early part of his career was in Finance in various industries, including Defence, Financial Services and Telecommunications. Peter worked for GE Capital throughout the 90’s including spells in Manchester, Brussels, Shannon (Eire) and Connecticut in various Quality Leadership roles

From 2000 to 2013 he worked in Telecoms in the UK, first with Vodafone, then Cable & Wireless, before finally leading Operational Excellence for Virgin Media.

From 2013 to 2015 Peter led Process Excellence in Northern Europe for Maersk Line, based in Copenhagen

Since February 2016 Peter has been Director of LCI (LEGO Continuous Improvement) at LEGO with specific responsibility for Business Service Operations and is actively involved in establishing a Global Business Services Organisation for Finance, HR and other services

Peter is a Six Sigma MBB, a Lean Practitioner and has a deep and lasting interest in Change Management and the psychology of Change.

Peter Lives in Newtown, Wales, UK with his wife Amanda, Dogs Harvey and Maisie and various other pets and pests.


FSMA and Beyond: Documentation and Records Management as a Food Manufacturing Best Practice

FSMA and Beyond: Documentation and Records Management as a Food Manufacturing Best Practice

  • FDA expectations for FSMA documentation compliance
  • Best practices in developing Food Safety Plans and Food Defense Plans
  • Organizing and documenting your Supply Chain Program
  • FDA records access
  • Litigation implications of documentation and documentation practices

Stuart Pape
Chair Food & Drug
Polsinelli PC

Stuart assists clients in understanding and complying with regulations imposed by the FDA, USDA and similar health and safety regulatory bodies worldwide. He serves as the chair of Polsinelli’s Food & Drug Group. Stuart regularly appears before the FDA, USDA, the Consumer Product Safety Commission, the U.S. Customs and Border Protection, Federal Trade Commission, numerous other federal and state regulatory bodies, and the Congress of the United States. Previously, Stuart served in various positions in the Office of the Chief of Counsel at the FDA, including as Associate Chief Counsel for food. He also served as Executive Assistant to FDA Commissioner Donald Kennedy.

Dennis Dobbels
Co-Chair Food & Ag
Polsinelli PC

Dennis Dobbels offers clients an extensive background in all aspects of products liability, toxic tort and legacy liability, tax litigation, and insurance and complex commercial litigation. Dennis serves as Chair of the firm’s national Products Liability and Toxic Tort practice, as well as Co-Chairing the Food & Agricultural Group. In state and federal courtrooms around the nation, Dennis has handled single plaintiff cases and consolidated cases involving more than 100 plaintiffs. He also serves as National Trial Counsel, assisting clients with complex litigation issues.

Kathy Hardee
Co-Chair Food & Ag
Polsinelli PC

Kathy serves as Co-Chair of Polsinelli’s Food & Agriculture Group. Ever monitoring, writing and speaking on changes in food laws, Kathy serves as a Risk Manager for clients in an attempt to reduce litigation exposure. Should the need arise, she has extensive nationwide trial experience. Kathy is certified as a Preventative Controls Qualified Individual (PCQI) under FSMA and is HACCP qualified. She is also a trained mediator. Kathy represents clients in the food industry, toxic and mass tort litigation, product liability issues, business disputes and transportation disputes.


Quality Culture in an Expanding Environment

Quality Culture in an Expanding Environment

  • Advancing and maturing a Quality Culture in a growing company through value and purpose
  • Keeping a consistent message and model through onboarding and transition in the total supply chain
  • Demonstrating the power of putting people first and expecting them to be extraordinary
  • Introducing practical leadership approaches that compel and empower participants to move their organization beyond the constraints of the past and go to the next level of performance
  • Illustrating the value of soft skills of change management and effective communications to your team

Cloeann Durham
VP, Quality
Coca-Cola Bottling Company Consolidated

Cloeann is currently employed by Coca Cola Consolidated in Charlotte NC as a Vice President of Quality. Cloeann holds a Bachelor degree in Biology and minor in Chemistry from the University of North Carolina at Greensboro.

Cloeann has over 24 years’ experience in the Beverage Industry. Her career started immediately after college in Great Britain in Quality Assurance for a major beverage manufacturer. Since that time she has worked throughout the US supporting beverage manufactures in Waste Water and Water Treatment facilities, Dairy, Concentrate and Carbonated Beverages and also working with an FDA lab as a Pathogen Specialist. Cloeann has served as a member of the IFT (International Food Technologist), GFSI (Global Food Safety Institute), the Dairy Manufacturers Council, Food Safety Board and the ISBT ( International Society of Beverage Technologies). Currently Cloeann serves as the Former President of the ISBT (International Society of Beverage Technologies) and has also been a special presenter for the ISBT general assembly technical sessions, the IFT, Food Safety Symposium, and Keynote Speaker for Food Safety Summit.

The Three Steps Manufacturers Must Take to Succeed in Industry 4.0

The Three Steps Manufacturers Must Take to Succeed in Industry 4.0

As part of the 2018 edition of the North American Manufacturing Excellence Summit, Atul Mahamuni, Oracle’s VP, Internet of Things and Blockchain Cloud Applications, gave an in-depth interview on how manufacturers are embracing Industry 4.0 solutions with specific examples and lessons learned to illustrate what all successful rollouts of these new tools have in common.

The full transcript of the interview is below, or you can download a PDF version.

What is the real competitive advantage of the Industrial Internet of Things for the early adaptors, the companies that are well-launched into their journey?

First of all, the benefits of Industry 4.0 are all about productivity gains, about understanding our processes, about achieving our productivity goals through the reduction of unpredictability. Reducing things like unplanned downtime and increasing continuous production.

I would also say people have been talking about Industry 4.0 for a while now, so I think your question could also be, “Why are there so few companies that have successfully done something?”

I think that speaks to a void in the market that is impacting early adaptors.

Most vendors today are offering IIoT platforms, and there is a gap between the platform and what you need to build on top of an IIoT platform before you see a solution that delivers results. Early adaptors have had to take the risk of investing in a platform and building their solutions on top of it, and that’s what the early adaptors have done that their competition has not done.

What we try to do at Oracle is reduce that risk. It shouldn’t take a lot of time and money to create a custom solution. We believe it’s our job in the vendor community to create applications and solutions that our customers can deploy very quickly so they can see the ROI very quickly.

In a lot of conversations when we talk about new tools, new processes, at the end of the day it really comes down to people. Tell us a little bit about the people part of how manufactures are moving into Industry 4.0.

You cannot talk about moving into Industry 4.0 without talking about the people involved in that journey. There are two things that happen as we bring in new tools. We have people in the workforce doing the mundane job of data collection, and we also have people spending time on mid-level data analysis and operations research. Those things do not need to be done manually in an IIoT environment anymore with the help of machine learning and artificial intelligence, and that can lead to a little bit of resistance because we are changing the way people spend their time.

With that said, that initial friction quickly disappears, because we are actually helping people do their jobs better. Taking those boring jobs out of their hands and doing those better through automation very quickly demonstrates its value to the workforce: It helps them avoid the costly, stressful breakdowns that lead to high-stress environments that are created when a machine failure takes a production line offline.

Can you give us an example of what you are talking about?

We are working with a steel manufacturer right now. Their problem is they are building large steel sheets, and they explained to us that when something goes wrong in their manufacturing process, the sheets will jam in the machinery exactly the same way pages jam inside a printer, except imagine it is happening to a very large sheet of steel, right?

It is a major breakdown of productivity for them. They have to shut the whole line down, take heavy machinery apart, get the jammed steel out, and sometimes those sheets end up as scrap. It is a real mess, and this sort of thing impacts everyone.

With Industry 4.0 solutions, we are spotting the problems in the equipment and the processes earlier and more accurately than was possible before. We are able to anticipate where and when a breakdown will happen so the steel sheets can be corrected before the unplanned downtime. It really is benefiting people in the long-term, so once you get past that initial friction, that hesitation that their job is changing, they become very happy to see how the new tools are helping them to do their jobs better.

That’s when the culture starts changing.

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Overall Food Safety Culture: People, Processes, and Technology

Overall Food Safety Culture: People, Processes, and Technology

  • What makes our Workforce Development Learning and Training Program different?
  • Refreshing existing quality and safety programs through investment in new tools and technologies
  • Cross-pollinating new ideas and innovations throughout the company and our supply chain
  • Talking about Food Safety Culture as a constant work-in-progress. How do we continue to innovate?
  • Showcasing examples of positive change using Hershey’s Malaysia facility as a case study

Hugo Andres Gutierrez
VP, Quality, Food Safety, and Regulatory Affairs
The Hershey Company

Hugo Andres Gutierrez is Vice President, Quality, Food Safety, and Regulatory Affairs for The Hershey Company. In this position, Gutierrez provides leadership to Hershey’s global food quality, food safety, and regulatory programs in addition to implementation of 6 sigma programs across the company. Recently, he has been given the challenge of building a Supply Chain Learning and Development team for the Company.

Gutierrez has 20 years of experience in leading global, virtual and multi-cultural quality, food safety and regulatory teams.

Prior to joining Hershey, Gutierrez served as Director of International Quality and Regulatory Operations (QRO) for General Mills. In this position, he was responsible for working with regional and international functional leaders to enhance food safety culture, quality systems, and food safety programs. Gutierrez also worked to strengthen the Quality organization by developing leaders that could support the technical area while connecting with the business side of the company around the world.

His career with General Mills also included positions of Director, QRO for the Yoplait Division and Technical Development Director for Latin America and South Africa.

Prior to General Mills, Gutierrez held QA-related positions with Cadbury Schweppes USA, Pfizer in Canada and Chicle Adams (Warner Lambert) in Colombia.

Gutierrez holds a BS in Industrial Engineering from Javeriana University and an MBA from Icesi University, both in his native Colombia. He speaks fluent Spanish, French, English and basic Portuguese.

Gutierrez and his family reside in Palmyra, Pa.

The Myth of Out-of-the-Box Blockchain: Three Things to Know Now

The Myth of Out-of-the-Box Blockchain: Three Things to Know Now

Considering a leap to a blockchain system for food safety? We’ll cover:

  • How do blockchain systems work?
  • Will your workflow change? And if so, how?
  • Three questions you should always ask before committing to blockchain systems
  • Which complementary technologies magnify the power of blockchain systems—and which fail to fully meet food safety needs?
  • Which similar powerful technologies are available in ready-to-use format today?

Matt Smith

Matt is the founder of ICIX and is responsible for determining the company’s vision and strategy and cultivating industry relationships. Since ICIX was established in 2004, Matt has been instrumental in securing many of its flagship customers and is a recognized authority in supply chain risk management and product safety. An active event speaker, he works with industry, government and advocacy groups to determine and champion industry-wide supply chain solutions. Prior to founding ICIX, Matt managed sales and client services at Megabus, a leading Australian accounting solutions company. He is also an accomplished sailor and served as one of the world’s youngest professional mega yacht captains.

Business Bootcamp – Driving Greater Execution, Engagement, and Ultimately Earnings!

Business Bootcamp – Driving Greater Execution, Engagement, and Ultimately Earnings!

Are you ready to accurately assess your teams, your leaders, and your performance? For 25 years, Competitive Solutions, Inc. has been taking organizations through Business Bootcamp with some pretty dramatic results. Learn how to:

  • Drive Business Acumen at a tactical level
  • Move accountability from a concept to a practice and elevate expectations of engagement
  • Eliminate hours of meetings a week by recalibrating intent
  • Moving from abstract OPEX tools to business critical necessities
  • What are the eight essential elements of 21st century leaders?

Shane Yount is a nationally recognized author, speaker and principal of Competitive Solutions, Inc. Shane began his career with Perdue Farms, Inc. His “Real World” process driven approach to creating and sustaining high performance has led leaders across the country to embrace the Process Based Leadership® methodology as a core operating system in driving organizational focus, urgency, and accountability. Since 1991, he has led the offices of Competitive Solutions, Inc. to become one of the nations most recognized Business Transformation consulting firms, working first-hand with Michelin, Glaxo Smith Kline, Pfizer, Lockheed Martin, the Department of Defense and many others. Shane’s approach of challenging leaders to confront what truly “powers performance” within their organizations gives leaders a unique glimpse into their personal leadership legacies.


Panel: Generating High Productivity Through Training and Total Workforce Engagement

Panel: Generating High Productivity Through Training and Total Workforce Engagement

  • What does investing in your people look like on a day-to-day ongoing basis?
  • How does the workforce contribute to steady cumulative improvements as the engine of long-term culture change and improved productivity?
  • Discussing motivational tools that solicit grassroots contributions: Competition, recognition, entertainment, and a sense of accomplishment
  • Offering examples where training, mentorship, job shadowing, and cycling through different job functions improves retention, job satisfaction, and contributes to improved performance
  • How far can a culture of continuous improvement and total workforce engagement permeate an organization?

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Digital Enterprise – Implement Now

Digital Enterprise – Implement Now

The technical prerequisites for Industry 4.0 are available. Digitalization is actively gaining competitive advantages. Now is the time to implement. Experience the Digital Transformation now taking place across various industries.

  • Siemens case study of time, cost, quality results achieved from their own digitalization journey
  • Learn the advantages of industries working together utilizing intelligent, predictive models (Digital Twins)
  • Illustrative examples presented to explain how virtual and real are being connected across the entire value chain

Michael Schroeder
Portfolio Development Executive CPG and SHF
Siemens PLM Software

Michael Schroeder is Portfolio Development Executive for Siemens Consumer Products and Retail Product Lifecycle Software. In his role for Siemens, Michael works across fast moving consumer goods companies enabling them to Think Big, Act Small and Scale Fast – utilizing modern digitalization strategy and technologies.

Michael combines a multi-disciplined background across Consumer Products, Food & Beverage, Health & Beauty, Softlines, Hardlines, Footwear and Apparel. His background includes running R&D, design and engineering facilities tied to global manufacturing operations. Achieving award winning global brand strategy, product & package design. He is an innovation leader, holding multiple patents. He thrives on helping numerous large and small businesses alike to realize their full potential in synchronizing innovation with operations and delivering to plan.

Building the Manufacturing Capabilities for the Future to Enable Healthcare Transformation

Building the Manufacturing Capabilities for the Future to Enable Healthcare Transformation

  • Recognizing and acknowledging the major healthcare trends and disruptors
  • How does embracing these trends impact manufacturing capabilities and the end-to-end Supply chain organization?
  • How are we developing a bold and holistic manufacturing transformation strategy, framework and deployment approach to address these implications and meet future customer and market expectations?
  • Offering insights into how to connect and seamlessly integrate the Technology Innovation Process (Mode 2) with the “Operational World” (Mode 1) for broad adoption and deployment across business segments
  • Sharing of critical success factors for implementation of this manufacturing and technology transformation to drive sustainable business and customer impact:
    • Emphasizing the importance of upfront exploration and industrial research
    • Building initial capability and accelerating organizational learning through an agile “test and learn” philosophy
    • Establishing broad business engagement early on in the journey and building & leveraging core strategic external partnerships
  • Understanding the criticality for having a robust Standard Operating System to deploy and scale new capabilities, processes, systems and technologies in a consistent and sustainable way

Bart Talloen
VP Product Supply
Johnson & Johnson

As an executive supply chain leader for more than 25 years, Bart has a proven track record of success across several key SC functions such as Planning, Engineering, Technology Transfers, Project Management, Continuous Improvement, Mfg Operations, and General SC Management in Asia, Europe, and North America.

During his career in pharma, OTC, consumer goods, and logistics/ material handling, Bart has managed large supply networks, has acquired and divested operations, build new plants but also has overseen the closure of plants, and has developed and executed a three-year Consent Decree Work Plan including the successful re-certification of three US OTC manufacturing plants by FDA.

In his current role as Vice President, Product Supply Strategy & Deployment, Bart is responsible for developing and deploying advanced processes & capabilities, agile OT systems and disruptive technologies to improve the end-to-end Supply Chain performance.

Bart is also responsible for the J&J Supply Chain Academy to provide enterprise-wide subject matter learning & development programs and build future leadership capabilities for the end-to-end Supply Chain organization.

He and his wife live in Skillman, NJ and have two sons in college.


Augmented Reality on the Shop Floor

Augmented Reality on the Shop Floor

  • How are new tools like augmented reality changing and improving the way we operate?
  • What challenges have limited the scope of this sort of technology until recently, and what has changed?
  • Working with industry partners and collaborators to develop in-house expertise to get the most out of these new capabilities
  • Walking through real-world examples where augmented reality is the difference-maker driving improved performance in our operations
  • Demonstrating the scalability of augmented reality on the shop floor: What can other organizations learn from our experience?

Derrick Register
VP, Supply Chain
Coca-Cola Refreshments

Derrick is a highly motivated leader who believes in achieving success through building exceptional teams. He believes teams that exhibit great communication, leadership, and job competency, furnish exemplary results. Derrick worked in the Automotive Industry for most of his career. While working for Meridian Automotive Systems, his responsibilities included Environmental Health and Safety Engineering. Most of his success was in managing several launch facilities where he implemented ISO 14001 and EHS Programs. Derrick was promoted to Plant Supervisor, responsible for productivity metrics that drove the financial budget.

After one year, he advanced to Operations Manager with P&L (profit and loss) responsibilities at multiple sites. In this role, Derrick’s direct responsibilities included managing the production and assembly departments, quoting, overseeing launches, budget development, customer liaison, quality auditing and implementation, capital justification and business plan development.

Later, Derrick traveled abroad on a special assignment with Ford Motor Company in Cologne, Germany, where he served for several years as a Program Manager on the global vehicle platform for future model vehicles. He developed the process flow to collect multiple inputs from the consumer business groups worldwide. After successfully completing that assignment, he moved to Product Planning to gain experience on vehicle development. There, he was responsible for developing the business cases for all Small Car platforms out of APA (Asia, Pacific and Africa) Consumer Business Group, which included engineering, marketing, purchasing, finance and cost estimating inputs to achieve financial targets. The Small Car platform accounted for 15 percent of the overall business in APA.

Over the past 7 years, Derrick has performed as the General Manager at Coca-Cola Refreshments in the following locations, Detroit – MI, Bellevue – Washington and Dinuba – California. As the GM, he was responsible for the entire operation of producing and transporting carbonated beverages, Dasani Water, Hot Fill and NHB (Natural Health Beverages).

He served as Director of Manufacturing – Northwest, Vice President of Manufacturing – Northern Texas and Vice President of Manufacturing – West Region. He has had P&L responsibility for as many as 16 locations including co-manufacturing, which includes development, distribution, and strategic business planning. Most recently, he served as Vice President of Supply Chain for the US Region, which includes Planning, Operational Excellence, Human Resources, Procurement, Quality, SES, and Engineering.

Derrick received a Bachelor of Science, Occupational, Safety, and Health with an engineering minor from Grand Valley State University and a Master’s in Business Administration with emphasis in Operations Management from Lawrence Technological University.

He volunteers throughout the year with various organizations. During the holiday season, he participates in feeding the sick and shut-in, homeless, and special needs citizens through Tabernacle Missionary Baptist Church. He serves as a mentor in the SOAR program-assisting elementary schools children improve their reading skills through Grace Community Church. Serves on the Parking Lot ministry at Grace Community Church. Acts as a sponsor for the Special Olympics – Washington. Participates in a host of activities to assist the local community when called upon.

Derrick Register is a native of Detroit, Michigan. He is a proud husband to wife, Rajoielle and father to beloved daughter, Blake and son, Derrick. In his spare time, he enjoys spending time with his family, mentoring, traveling, reading and sports.

Panel Discussion: Pharma 4.0 – Biopharmaceutical Production in the Digital Age

Panel Discussion: Pharma 4.0 – Biopharmaceutical Production in the Digital Age

  • Addressing the state of the biopharmaceutical industry today: Which emerging trend will see the most growth?
  • Embracing modular automation, PAT and continuous processing to increase agility, flexibility and improve efficiencies
  • People and technology: How are these forces working together to grow and mature our industry?
  • IoT- how will cloud based data, data analytics and data integrity evolve compliance and quality towards continuous improvement
  • How will these technologies affect patient and product needs towards more individualized therapies?


Alison Moore is Senior Vice President, Process Development for Amgen serving both Operations and R&D organizations. She has held a number of senior roles within Amgen overseeing operations technology, process and product engineering , and corporate manufacturing where she oversaw supply chain, contract manufacturing, global distribution, manufacturing technologies, and operations risk management. She also headed up Amgen’s Fremont, California, manufacturing facility (AFR). Before heading up the AFR facility, Moore was a director in chemistry, manufacturing and controls regulatory affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the process development organization. Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England.


Rohini Deshpande is the VP Process Development of Amgen. She joined Amgen in 1997 as a scientist in R&D. At present, she is Vice President Process Development and Head of Attribute Sciences. Attribute Sciences is a multi-modality global group across six Amgen sites. The scope spans preclinical to commercial. Previously, Rohini was Executive Director of Drug Substance group for Amgen Thousand Oaks. Her team developed production cell lines and processes for many Amgen biologics products. Prior to her 20 years at Amgen, Rohini did her post-doctoral work in antibody structure function at UCLA, before that she worked as a post-doctoral fellow establishing a Yeast two hybrid system at University of Michigan, Ann Arbor, and prior to that she did her Ph.D. in Biology with an emphasis on Immuno endocrinology at SUNY Binghamton.

Christie Bielinski is the Vice President of Product Quality Management of Janssen Pharmaceuticals. She leads a world-wide organization of quality professionals accountable for the development, manufacture and launch of pharmaceutical products across the Janssen therapeutic areas. The scope of her responsibilities include assuring that the quality requirements are built into the product in early and late-stage development, that proactive identification of ‘critical to quality attributes’ are identified, and that the associated risk is quantified so that defects can be prevented during the entire lifecycle of the product. In her 11-year career with Johnson & Johnson, Christie has held positions in both the Medical Device and Pharmaceutical segments and has had responsibility for marketed products that span a diverse portfolio of Pharmaceuticals, Biologics, Devices and Combination Products. Her responsibilities during this tenure have included new product development and lifecycle management, supplier quality, validations/site qualifications, laboratories, quality operations and network optimization.

Craig Beasley is the Vice President of Manufacturing Operations at Juno Therapeutics, a clinical-stage cell immunotherapy company focused on revolutionizing medicine by re-engaging the body’s immune system to treat cancer. Prior to joining Juno Therapeutics, Craig worked at Biogen for sixteen years in roles of increasing responsibility in process engineering, manufacturing, supply chain, site operations, and financial planning functions. Craig has a BS in Chemical Engineering from Purdue University.