Advisory Board

Emerson Process Management is a solution provider helping manufacturers in the life sciences industry to automate their production and processes through operations management, process automation and asset management.
Emerson’s Syncade™ operations management solution provides manufacturing control to optimise work processes; implemented in a modular and scalable manner it enables the user to address specific functions as required. Syncade provides solutions for:

• Electronic Batch Records – Embed quality into the manufacturing process to ensure the identity, quality and safety of the product is manufactured right first time and in a consistent and reproducible manner.
• Weigh and Dispense – Guides operators as materials are pulled from inventory and weighed for specific production needs. Features include full weigh-scale integration, bar code scanning and printing, material health and safety display, integration with enterprise ERP systems, embedded SOP document viewing and a dispensing dashboard for ongoing weighing operations display at a glance.
• Materials Management – Supports material workflows to manage the purchasing, receiving, warehousing, and shipping of materials.
• Equipment Logbooks – Eliminate the need for paper-based logbooks for equipment cleaning, calibration, and maintenance activities. Allows operators to quickly review and approve the equipment status at the point-of-use, enforcing electronic signature verification and approval.
• Electronic Document Management – Maintain full control of their documents, including version management and electronic routing, review, and approval.

By adhering to industry standards, this solution reduces engineering, testing, and maintenance costs. Emerson combines this technology solution with engineering, consulting, and project management to deliver a best in class service and solution.

In addition, Emerson can assist customers with the implementation of creating a Process Analytical Technology based solution with data modelling, data management, and recipe configuration.

Industry Study

From Industrie 4.0 to Pharma 4.0

• Managing the additional challenges in pharmaceutical operations
• Applying the ICH control strategy in Pharma 4.0 operations
• Pharma 4.0 Lifecycle Management

Werum IT Solutions is the internationally leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical indus¬tries. Its out-of-the-box PAS-X software product is run by the majority of the world’s top 30 pharmaceutical and biotech companies but also by many mid-sized manufacturers.
Werum provides integrated IT solutions for all phases of production – including process development, commercial production, and packaging as well as track & trace serialization. PAS-X MES helps pharma manufacturers to increase efficiency, im¬prove productivity, and meet regulatory require¬ments.  The company is headquartered in Lüneburg, Germany, and has many locations in Europe, America, and Asia. Werum is part of Medipak Systems, the Pharma Systems business area of the international technology group Körber. Körber unites around 11,500 professionals in industry-leading companies worldwide, achieving annual earnings of 2.3 billion Euros.

Conference Chair

As a research-focused healthcare company, Roche discovers, develops and provides innovative diagnostic and therapeutic products and services that deliver significant benefits to patients and healthcare professionals – from early detection and prevention of diseases to diagnosis, treatment, and treatment monitoring. From the very beginning, Roche’s visionary founder focused his company on innovation and on establishing an international presence. This multinational presence reinforces our ability to offer our healthcare solutions and to anticipate needs in all regions of the world. Today, Roche employs more than 80,000 people and sells its products in more than 150 countries. Roche ranks among the world’s leading healthcare companies and has two strong core businesses: diagnostics and pharmaceuticals. Focusing on the creation and commercialization of medically differentiated products and services that lead to a tangible improvement to the health, quality and length of patients’ lives.

Conference Chair

HGP is one of the leading business consultancies specializing in the healthcare industry. Based in Switzerland, with subsidiaries in Germany and Singapore, the company has experienced substantial growth since it was founded in 2008.

Our expertise lies in the efficient use of technology, streamlined processes and standardization that is required in today’s healthcare industry which researches, produces and markets in global networks. HGP provides expert consultancy for GMP, quality, risk & compliance management, successful implementation of LEAN, paperless manufacturing and MES and the passing of audits and inspections.

Our clients are SMEs, global corporations, manufacturers and suppliers in the following fields: pharmaceutical and bio-pharmaceutical industry, medical devices, manufacturers of packaging machinery, processing equipment and also software providers for the pharmaceutical industry.

Our international approach with sites in strategically important pharmaceutical industry locations enables us to carry out even global projects with the necessary expertise and presence.

Advisory Board

World class through Efficiency & Transparency

Integrated processes, from shop to top floor, from planning to distribution, is a strategic objective but yet remains a major challenge for most companies in the regulated industry. Full benefits cannot be achieved by just installing alone a system for process control. To reach that full potential – situational analysis, specifically tailored concepts and efficient implementation strategies must be developed in close alignment with the company’s organisation, associated culture and established processes.

We at prime4services actively engage and support your organisation to realise the maximum use and optimal potential across all processes and company levels. With our agile and innovative approach we ensure an optimal and efficient implementation of projects.

Use our skills and rich experience for your benefit!

Our methodology-based approach brings together processes, technologies and people. This holistic approach leads to a solution that makes optimal use of both existing and new systems / resources – neutral and vendor-independent.

Keynote

Last developments in the OPEN Serialization Communication Standard Workgroup

• Where does OPEN-SCS stands for?
• Overview of the current organization and members
• What where the last achievements?
• What’s in Work Product 1.0?
• What can you do with it and what’s the value proposition?
• Roadmap and future of OPEN-SCS?
• What are the benefits to join?
• How to join?

Driven by Healthcare Providers, the Open-SCS initiative directly addresses the Healthcare Industry’s Product Serialization Regulation Wave of the next decade. The Open SCS Working Group (Open-SCS) is partnered with the OPC Foundation to develop an open source standard in the Packaging Serialization Global Name Registry and an associated set of subscription-based work products.  The open standard and work products are focused on the standardization of data exchanges for Healthcare packaging serialization and the aggregations between a Healthcare provider’s  enterprise serialization management function and their product packaging lines.  This includes interfaces between Levels 2-to-3 and 3-to-4 for Level 2 plant (line and equipment) and supply chain packaging serialization activities (distribution centers (DC) and warehouses) and Level 3 functions (plant and warehouse operations management). The scope of the 2016/17 work products focuses on data exchanges for 6 proposed use cases in two data exchange categories:  1. Mandatory Services and 2.  Support Services which are addressed in  6 common Packaging Line Serialization System Configurations.

www.opcfoundation.org

Challenge Your Peers

End to End Track & Trace, from Manufacturing to the Patient - How to manage product complaints and potential recalls?

• How to deal with pharmaceutical complaints?
• How to navigate the intricacies of the product complaint and recall regulatory landscape?
• How to improve your complaint and recall management to ensure safety in your products?
• How to develope a Safe and Connected Pharma Supply Chain? 
• How to align different traceability concepts which impacts all pharmaceutical supply chain stakeholders?
• How to integrate quality assurance & compliance in global pharma supply chains?
• How to align business procedures with supply chain processes to improve processes and to have an efficient product life cycle management?

Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place, as well as some of the world’s best-known consumer healthcare brands. Every day, our colleagues work in developed and emerging markets to treat, cure and eradicate life-threatening conditions and challenge some of the most feared diseases of our time. Pfizer also collaborates with healthcare providers, governments and local communities to support and expand access to reliable, affordable healthcare around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.

http://www.pfizer.com

Advisory Board

AND

Challenge Your Peers

How to convert the burden of T&T into a benefit by making use of Big Data?

• Data is the new world currency, its usage the business driver of the future
• T&T creates tons of serialization data … and even more metadata
• Ideas & concepts to use such data, e.g. in manufacturing performance control

World class through Efficiency & Transparency

Integrated processes, from shop to top floor, from planning to distribution, is a strategic objective but yet remains a major challenge for most companies in the regulated industry. Full benefits cannot be achieved by just installing alone a system for process control. To reach that full potential – situational analysis, specifically tailored concepts and efficient implementation strategies must be developed in close alignment with the company’s organisation, associated culture and established processes.

We at prime4services actively engage and support your organisation to realise the maximum use and optimal potential across all processes and company levels. With our agile and innovative approach we ensure an optimal and efficient implementation of projects.

Use our skills and rich experience for your benefit!

Our methodology-based approach brings together processes, technologies and people. This holistic approach leads to a solution that makes optimal use of both existing and new systems / resources – neutral and vendor-independent.

Challenge Your Peers

How to drive business value from Serialization beyond compliance?

• How to define „Business Value“?
• What are pre-requisites to throughly increase visibility?
• How to get a better understanding of product flows?
• Is end to end security (from manufacturing site to patient) really manageable or a mere illusion?
• How does serialization force you to restructure your internal processes?

Ferring Pharmaceuticals is a research-driven, biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive health, urology, gastroenterology, endocrinology and orthopaedics.

The company's research activities and products are connected by a common focus of providing tailored treatments that work on the body's own terms, enabling doctors to combat numerous diseases and medical conditions.

Ferring has its own manufacturing facilities in several European countries, in South America, Israel, India and China. It is also currently building new facilities in the USA. With the acquisition of Bio-Technology General in 2005, it has capabilities in recombinant biotechnology as well as more traditional pharmaceutical manufacturing.

Ferring's marketing, medical services and sales teams, led by the corporate headquarters in Saint-Prex, Switzerland, operate from nearly 60 countries and employ over 6,000 people throughout the world, while treatments are available in 110 countries. This expansion has allowed Ferring to maintain a double-digit annual growth rate over the last two decades.

www.ferring.com

Challenge Your Peers

Operational challenges from Production and IT perspectives

• How do you manage a serialization software updates in a complex and layered IT systems architecture?
• How do you manage infrastructure / operating system updates (including emergency patches like wannacry virus) in a complex and layered IT systems architecture?
• How do you maintain the validated status of a cloud solution (SaaS), for example Tracelink?
• How do you deal with audits (done in a local site) if track & trace is implemented as a global system?

HGP is one of the leading business consultancies specializing in the healthcare industry. Based in Switzerland, with subsidiaries in Germany and Singapore, the company has experienced substantial growth since it was founded in 2008.

Our expertise lies in the efficient use of technology, streamlined processes and standardization that is required in today’s healthcare industry which researches, produces and markets in global networks. HGP provides expert consultancy for GMP, quality, risk & compliance management, successful implementation of LEAN, paperless manufacturing and MES and the passing of audits and inspections.

Our clients are SMEs, global corporations, manufacturers and suppliers in the following fields: pharmaceutical and bio-pharmaceutical industry, medical devices, manufacturers of packaging machinery, processing equipment and also software providers for the pharmaceutical industry.
Our international approach with sites in strategically important pharmaceutical industry locations enables us to carry out even global projects with the necessary expertise and presence.

Challenge Your Peers

Operational challenges from Production and IT perspectives

• How do you manage a serialization software updates in a complex and layered IT systems architecture?
• How do you manage infrastructure / operating system updates (including emergency patches like wannacry virus) in a complex and layered IT systems architecture?
• How do you maintain the validated status of a cloud solution (SaaS), for example Tracelink?
• How do you deal with audits (done in a local site) if track & trace is implemented as a global system?

Vifor Pharma Group, formerly Galenica Group, is a global speciality pharmaceutical company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
Vifor Pharma has set up this community to share with you news about the company and the current open positions. Sensitive topics, such as discussions about products or treatment options should be addressed privately with your physician. If you are concerned with an adverse event of a drug or a complaint regarding a product, please directly email safety@viforpharma.com or call +41 79 788 03 09.
Political and religious discussions are not allowed on this site, as well as inflammatory, defamatory and racist comments. If it is believed that the end result of a discussion will be political, religious or contains inappropriate statements the post may be removed.

www.viforpharma.com

Challenge Your Peers

How can CMOS and CDMOS set up a efficient serialization strategy to fulfill business and customers needs?

• Servieportfolio: How broad a range can you offer and still meet all requirements?
• What is an adequate investment split between providers and customers?
• What are realistic timeframes for onboarding processes?
• How to organize unified reporting and regulations for a variety of customers?

Experience development and team spirit.
"Start your career in a company that takes responsibility - for people and the environment."​

R-Pharm is one of the leading pharmaceutical companies for hospital and specialized therapeutics in Russia and Eastern Europe with offices in the USA, Japan, Turkey and India. In 2014 the company achieved sales of around 1 billion US dollars.

R-Pharm secures itself the strategic development toward Western Europe through the plant in Illertissen. With its approximately 350 employees, the site is one of the most modern and innovative production facilities worldwide for conventional and high potent (OEB 4/5) manufacturing and packaging of medicinal products and nutritional supplements.

We produce quality, therefore we are seeking for employees who are enthusiastic about progress and innovation. You will find that at R-Pharm corporate culture, employee development, sustainability and corporate social responsibility is taken seriously and lived by all on a daily basis.

We have piqued your curiosity? Here you will find
• More about staff development at R-Pharm
• More about our values
• More about our corporate culture and social responsibility

Website: www.r-pharm.de

Challenge Your Peers

Enabling End to-End Supply Chain Planning, Visibility, and Decision Making through Standardization and Integration – What are the challenges for a packing & labelling CMO?

• What are current serialization implications for manufacturers and supply chains?
• How to implement a future-proof Serialization Strategy on Company Level?
• How can complexity be reduced in the packaging process with regards to serialization and product  declaration?
• What are the reasons to implement a central serialization solution on ISA95 Level 4?
• Which interfaces are necessary to guarantee secure flow of data to lower levels, external partners such as CMOs or national hubs?
• What is the best way to centrally manage serial numbers?
• How should scalable workflows look like to allow adaptation with minimum effort for revalidation?

As a specialized pharmaceutical company in the ophthalmic field, Santen Pharmaceutical Co., Ltd. is dedicated to improving the eyesight and health of people. We perform all our business and CSR activities in line with Santen's Values -Tenki ni sanyo suru- from which our Company's name derived. As Santen's employees, we are fully aware that our mission is to think and act autonomously to benefit patients and their loved ones, thereby contributing to society.

www.santen.com

Challenge your Peers

The upcoming delayed FDA regulations – What does it mean, what’s to expect and what’s TO DO?

Acorda Therapeutics is a publicly traded (NASDAQ: ACOR) biotechnology company whose mission is to develop therapies that restore neurological function and improve the lives of people with neurological disorders.

We started our company in 1995 as a network of scientists, physicians and business people with a common belief that sharing ideas and information could lead to innovative medical advances for people with neurological disorders.

We have since evolved into a commercial-stage biotechnology company, successfully developing and commercializing important therapies that advance the care of people affected by neurological conditions. We achieve our goals by:

•  investing in research and development
•  collaborating closely with the patient, medical and scientific communities
•  retaining employees with compassion and commitment

Acorda has been voted one of the best companies to work for in New York for the past five years in a row, as a result of our dynamic environment, strong corporate culture, significant emphasis on research and development, and a robust product pipeline. We are positioned to be an industry leader, poised for exceptional growth.

http://www.acorda.com

Now a Certified B Corporation, OPTEL is a leading multinational provider of traceability systems, and its mission is to use its innovative technologies to create a better world through responsible capitalism. The company’s renowned solutions ensure the quality of consumer health products and help stop counterfeiting of pharmaceuticals and medical devices throughout the world. OPTEL is also adapting its technologies to create efficiencies in various other sectors ─ from health-related industries to smart manufacturing and more, all can benefit from global traceability. OPTEL’s expertise will allow diverse industries to measure, inspect, control and track a variety of elements to improve quality and make better use of resources.

www.optelgroup.com

Opening Keynote

The Countdown is running: Updates and Must-Knows about the EU-Hub On-boarding Process.

• FMD Implementation in Europe
• EMVO’s On-boarding Process for Pharmaceutical Companies
• Status quo in the 32 Member States
  • (- Set up of National Medicines Verification Organisations)

The European Medicines Verification Organisation (EMVO) has taken responsibility for advancing the formation of the European Medicines Verification System (EMVS). The EMVS is in accordance with the EU’s Falsified Medicines Directive (FMD) and the Delegated Regulation (DR). IT ensures the implementation of a functioning, secure, interoperable and cost effective system across Europe.

The infiltration of falsified medicines in the European supply chain is a major and continuous threat for the patient health and security. Because patient health and safety is of the utmost importance to the pharmaceutical industry, a comprehensive strategy at European Level is required. Therefore the European Medicines Verification Organisation (EMVO) was created as a joint initiative of EU stakeholders, representing manufacturers (Medicines for Europe, EFPIA, EAEPC), wholesalers (GIRP) and community pharmacists (PGEU). Further information about our stakeholders is available at Stakeholders.

www.emvo-medicines.eu

Keynote

Counterfeiting and traceability – The latest and newest from across the globe

• Latest regulatory developments worldwide
• EPCIS as THE chosen standard to exchange information for traceability – why and how
• Experiences and learnings – how to prepare for upcoming deadlines

GS1 is a leading global organisation dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors. The GS1 system of standards is the most widely used supply chain standards system in the world.

•     GS1 is a fully integrated global organisation with over 30 years experience in global standards.
•     GS1 offers a range of products, services and solutions to fundamentally improve efficiency and visibility of supply and demand chains.
•     GS1 operates in multiple sectors and industries.

Website: www.gs1.org

Keynote

GO LIVE Serialization - 5Ws Stress test for your company: Is your orgnization fit for mandatory Serialization?

• What will happen? -  EU Falsified Medicines Directive, Drug Supply Chain Security Act (DSCSA), etc.: Implications of such regulatory requirements.
• When does it take place?  -  Setting up timelines to meet regulatory requirements.
• Why does it happen?  -  Raising awareness in management and the affected sites and functions.
• Who is involved?  -  Considerations along the supply chain, Helpdesk, reverse logistics.
• Where does it take place?  -  Identifying organizational weak spots.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Still headquartered in Ingelheim, it operates globally with 146 affiliates and more than 47,700 employees. The company's key assets of interest are: respiratory diseases, metabolism, immunology, oncology and diseases of the central nervous system. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. Boehringer Ingelheim is a full member of the European Federation of Pharmaceutical Industries and Associations EFPIA.

Case Study

Overcoming pitfalls on the way to tamper evidence and serialization Set-up of timelines

• Key decision factors: Finding the suitable partners
• Meeting different levels of customer readiness
• Special requirements of the product portfolio (non-obvious multi-level coding needs)
• Answering questions on tamper evidence beyond Track & Trace
• Pitfalls for implementation of tamper evidence in daily business: Where do we see the real problems?

The KLOCKE GRUPPE is a group of consolidated companies, working in the field of contract manufacturing and contract packaging.

In 2017, the KLOCKE GRUPPE employs approx. 2.200 people at the following sites:

Klocke Verpackungs-Service GmbH in Weingarten (Baden)
Klocke Pharma-Service GmbH in Appenweier
IDT Biologika GmbH in Dessau-Roßlau
Klocke France in Strasbourg (Frankreich)
Klocke of America in Fort Myers (USA)
Pharmapack Stade GmbH in Stade

Its core activities are the development, manufacturing and packing of pharmaceutical forms, medical devices and dietary supplements, the manufacturing of vaccines, the manufacturing of sterile forms, as well as the filling of semi-solid and liquid forms in the fields of cosmetics, veterinary, OTC, HBA, perfumes, food and chemical-technical products.

Website: www.klocke.com

Case Study

Track&Trace beyond compliance: Creating Business Value building business strategy around T&T implementation

• Compliance need vs Business need for implementing T&T
• Setting up projects from a strategic point of view
• Business Benefits of T&T:
  • Visibility along the SC
  • Implications for operations planning
  • Customer centric
• Results and value at Galderma

For over 30 years, all our resources have been channeled in a single direction: to provide innovative medical dermatological solutions that meet the needs of patients and physicians with a particular focus on acne, rosacea, psoriasis and other steroid-responsive dermatoses, onychomycosis (fungal nail infections), pigmentary disorders, skin cancer and medical aesthetic and corrective solutions for skin senescence. The skin conditions we treat can have strong psychological and social implications in the everyday lives of our patients. By treating these conditions, we help people preserve, restore and maintain healthy skin and improve their quality of life.

Today, Galderma is a global dermatology company partnering with healthcare professionals to provide innovative medical solutions to patients with skin health needs. The company has 35 wholly-owned affiliates and a worldwide network of distributors, over 6 000 employees and an extensive product portfolio available in more than 100 countries.

Galderma’s R&D is continually dedicated to finding new medical solutions, offering physicians more options and offering patients a better quality of life. Five state-of-the-art R&D centers and six manufacturing sites are dedicated to providing a wide range of innovative medical solutions which meet the highest standards of safety and efficacy.

Case Study

Stearing towards a global serialization programme – Opportunities and challenges for a CDMO.
Roadmap for Project Serialization: Allocating resources, setting up a timeline and developing an action plan.
Opportunities – Using serialization to drive your company past the competition
Implementing full Serialization as competitive advantage: Not everyone can afford to take on the projects.
Time to market as a crucial factor: Avoiding increasing lead times and delays in equipment delivery.
Challenges – Pitfalls to cakein to account and overcome.
Up front investements or flat fee: Negotiating with your customers and suppliers.
Defining the scale of your portfolio: Serialization & Aggregation I Standardized versus Customized: Which products & services can you offer in the designated time given?
Onboarding your customers: How much time is enough to have all your clients up and running?
Being compliant in all matters with increasing regulatory around the globe: How to set up reporting to fulfill directives and comply with acts?

Recipharm is a partner for contract pharmaceutical development and manufacturing. With production facilities across Europe, recipharm is uniquely positioned to deliver reliable and flexible service for all their customers, wherever they are.
Recipharm supplies several hundred different products in a variety of dosage forms including solid dose, semi solids, steriles (liquids and freeze dried), beta-lactams, hormones, dry powder inhalers and granulates, from our various facilities across Europe. Recipharm’s Pharmaceutical Development Services group activities range from straight forward clinical supply through to more complex product development and formulation. From their pharmaceutical development centre they can work on a variety of technologies (including sterile products). Formulation Development, Clinical Supplies, Analytical Development, Stability Studies, Packaging Development and Raw Material Selection are all core activities.

PQE is a complete quality solution provider operating in the life science industry since 1998.  Thanks to the 16 offices worldwide from Japan to USA, we can rapidly support you anywhere you require in the following areas:  Data Integrity Assurance & Computer System Validation, Qualification & Engineering, Compliance, Regulatory Affairs and 3rd Party Audits.
Our unique capabilities enable companies to achieve and maintain compliance with FDA, EMA and other international, regional and local regulatory agencies.
We will support you to find the most sustainable way to develop practical and tailored plans that align global quality capabilities with your business strategy.

Industry benchmark

Smart Packaging enabling the Internet of Things: Consumer - Product Interaction Through NFC Technology

• Basic and Future requirements in packaging technology
• Industry Benchmark: What are customer and industry needs?
• How to set up an ecosystem to drive technological growth and progress
• What’s the actual technology you are using and how will it move the packaging world

Henkel operates globally with a well-balanced and diversified portfolio. The company holds leading positions with its three business units in both industrial and consumer businesses thanks to strong brands, innovations and technologies. Henkel Adhesive Technologies is the global leader in the adhesives market – across all industry segments worldwide. In its Laundry & Home Care and Beauty Care businesses, Henkel holds leading positions in many markets and categories around the world. Founded in 1876, Henkel looks back on more than 140 years of success. Henkel employs more than 50,000 people globally – a passionate and highly diverse team, united by a strong company culture, a common purpose to create sustainable value, and shared values. As a recognized leader in sustainability, Henkel holds top positions in many international indices and rankings. Henkel’s preferred shares are listed in the German stock index DAX.

Case Study

The „real“ implementation practice at DSM Sinochem Pharmaceuticals of the Serialisation solution of SAP ATTP in conjunction with the Pharma Network.

Royal DSM N.V. is a global science-based company active in health, nutrition and materials. By connecting its unique competences in Life Sciences and Materials Sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM’s 22,000 employees deliver annual net sales of around €9 billion. The company is listed on NYSE Euronext.

Challenge your Peers
Underestimated key criteria for high-quality coding to comply with DSCSA, UDI and FMD requirements

• How to ensure high-quality coding of alphanumeric & datamatrix codes?
• How to verify the appropriateness of your existing cartonboard?
• How the right combination of cartonboard quality & ink type impacts the coding result (grading) significantly?
• Do you limit your max. production line speed just because of actual cartonboard quality?

Videojet Technologies is a world leader in industrial coding and marking solutions with a dedicated global pharmaceutical team supporting organizations and supply chain partners with solutions, certifications and fast, reliable service. A product portfolio including thermal inkjet, laser marking, continuous inkjet and labeling provides consistent, high-quality serialization and traceability codes, helping the pharmaceutical and medical device industries safeguard their products against counterfeiting and protect consumer safety. With a wide range of technologies addressing virtually any application, Videojet is the expert in realizing the specific requirements of a wide range of healthcare applications.

With decades of knowledge, Videojet Technologies’ expertise in industry standards and global regulations makes them the right partner for understanding complex coding needs. Videojet solutions code 10 billion products a day worldwide, playing a vital and responsible role in the world. With over 4,000 associates serving 135 countries, Videojet has the capability to provide local service through global resources.

DSM Engineering Plastics is a global supplier of high-performance engineering thermoplastic solutions. It has a focused portfolio, with global leadership positions in many of its products in the areas of high-performance plastics, such as Stanyl®, Arnite® and Akulon®. DSM Engineering Plastics addresses key markets in automotive and electronics, and provides solutions to specialized industries including water management, breathable textiles and flexible food packaging.

Icebreaker

Regulatory evolvements in Track&Trace I Serialization

AND

Keynote

Last developments in the OPEN Serialization Communication Standard Workgroup

• Where does OPEN-SCS stands for?
• Overview of the current organization and members
• What where the last achievements?
• What’s in Work Product 1.0?
• What can you do with it and what’s the value proposition?
• Roadmap and future of OPEN-SCS?
• What are the benefits to join?
• How to join?

Driven by Healthcare Providers, the Open-SCS initiative directly addresses the Healthcare Industry’s Product Serialization Regulation Wave of the next decade. The Open SCS Working Group (Open-SCS) is partnered with the OPC Foundation to develop an open source standard in the Packaging Serialization Global Name Registry and an associated set of subscription-based work products.  The open standard and work products are focused on the standardization of data exchanges for Healthcare packaging serialization and the aggregations between a Healthcare provider’s  enterprise serialization management function and their product packaging lines.  This includes interfaces between Levels 2-to-3 and 3-to-4 for Level 2 plant (line and equipment) and supply chain packaging serialization activities (distribution centers (DC) and warehouses) and Level 3 functions (plant and warehouse operations management). The scope of the 2016/17 work products focuses on data exchanges for 6 proposed use cases in two data exchange categories:  1. Mandatory Services and 2.  Support Services which are addressed in  6 common Packaging Line Serialization System Configurations.

www.opcfoundation.org

• Why a standard in data exchange is critical for healthcare packaging serialization
• Packaging Serialization Specification 1.0 Use Cases
• Deliverables: Packaging Serialization Specification 1.0
• Agile Development of Specifications: Prototype, Validate Use Case, Draft Spec, Build Test Plan, Build Certification Criteria
• Why is the OPEN-SCS Certification Process
• Next Steps:
  • Why is the Open Packaging Serialization Global Name Registry
  • Planning Packaging Serialization Specification 2.0 and general next steps

and at the co-located 6th Pharma MES & Process Minds 2017:

Industry Study

Extending ISA 95 by Industrie 4.0

• Building an extended framework for interactive operations
• Overview of the updates on ISA-95 operations model
• Key aspects of Industrie 4.0 for End to End process management

Driven by Healthcare Providers, the Open-SCS initiative directly addresses the Healthcare Industry’s Product Serialization Regulation Wave of the next decade. The Open SCS Working Group (Open-SCS) is partnered with the OPC Foundation to develop an open source standard in the Packaging Serialization Global Name Registry and an associated set of subscription-based work products.  The open standard and work products are focused on the standardization of data exchanges for Healthcare packaging serialization and the aggregations between a Healthcare provider’s  enterprise serialization management function and their product packaging lines.  This includes interfaces between Levels 2-to-3 and 3-to-4 for Level 2 plant (line and equipment) and supply chain packaging serialization activities (distribution centers (DC) and warehouses) and Level 3 functions (plant and warehouse operations management). The scope of the 2016/17 work products focuses on data exchanges for 6 proposed use cases in two data exchange categories:  1. Mandatory Services and 2.  Support Services which are addressed in  6 common Packaging Line Serialization System Configurations.

Now a Certified B Corporation, OPTEL is a leading multinational provider of traceability systems, and its mission is to use its innovative technologies to create a better world through responsible capitalism. The company’s renowned solutions ensure the quality of consumer health products and help stop counterfeiting of pharmaceuticals and medical devices throughout the world. OPTEL is also adapting its technologies to create efficiencies in various other sectors ─ from health-related industries to smart manufacturing and more, all can benefit from global traceability. OPTEL’s expertise will allow diverse industries to measure, inspect, control and track a variety of elements to improve quality and make better use of resources.

www.optelgroup.com

World Café

Delivering the FMD through your Supply Chain

• What are regulatory requirements for your supply chain?
• Understanding your supply chain: What factors need to be considered?
• How to institutionalize business alignment including partner engagement?
• What are best fit delivery solutions?
• Which operational support models fit which companies’ needs best?

Enterprise System Partners (ESP) is a leading global consulting and project engineering company – supporting manufacturing IT solutions for the life science industry since 2003.
We offer specialist support and consulting services exclusively for manufacturing  and supply chain operations in biotechnology, pharmaceutical and medical devices, with core focus on Manufacturing Execution Systems (MES) and serialization.
We design, implement and integrate Manufacturing Execution Systems (MES).  Our key people have a collective knowledge of the entire systems landscape including Enterprise Resource Planning (ERP), Process Automation and Laboratory Systems.  In short, we understand how it all fits together and can deliver system projects for individual systems or an integrated solution across the systems landscape.
Our primary focus is delivering value to our clients by the selection and implementation of appropriate systems to achieve their goals, such as, increasing efficiency & flexibility, reducing the burden of compliance & meeting regulations (e.g. serialisation).   We have earned the respect of many of the keys vendors, yet remain vendor independent, so we can represent your needs exclusively.  We can operate at both site and corporate levels to achieve the best approach.  We will leverage experience and cost from past projects both within your corporation and from our expertise gained throughout our industry.

World Café

Integration of a Track & Trace Functionality in an Existing MES – What requirements and changes need to be done in the process and machine equipment?

• Did you had Site Impact Assessment workshop organized to assess all line upgrade needed due to serialisation. If yes when / what was the outcome and if Site Leadership Team approved proposed upgrade scope or challenged costs?
• Did you had PODA and / or T&T Process Workshop to assess all required changes in the processes / ways of  working required to implement serialization?
• Did you had Site Impact Assessment workshop organized to assess all IT upgrade needed due to serialisation. If yes when / what was the outcome and if Site Leadership Team approved proposed upgrade scope or challenged costs?
• How you are controlling / monitoring implementation of changed needed after all above point a,b and c?
• When you will serialized first EU SKU?

GlaxoSmithKline plc (GSK) is a British pharmaceutical company headquartered in Brentford, London. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham, GSK is one of the world's largest pharmaceutical company.

World Café

How to implement a future-proof and cost effective strategy for staying ahead of your competition?

• What are key requirements for unifying strategic, business and operations needs and how to meet them?
• Who is responsible for what and how do you get them involved?
• What is a realistic and successful timeline and how to stick to it? Long-term, short-term and according goals?
• How far can you stretch time and budget to still make your strategy a success?
• How to prepare your organizational structures to sucessfully implement (new) strategic goals?

As a specialized pharmaceutical company in the ophthalmic field, Santen Pharmaceutical Co., Ltd. is dedicated to improving the eyesight and health of people. We perform all our business and CSR activities in line with Santen's Values -Tenki ni sanyo suru- from which our Company's name derived. As Santen's employees, we are fully aware that our mission is to think and act autonomously to benefit patients and their loved ones, thereby contributing to society.

www.santen.com

World Café

How to ensure reliable and seamless management, sharing and reporting of your serialization data?

• L4 serialization and traceability Cloud System: what does it really mean / what for?
• How to easily ensure connectivity with multiple trading partners and facilitate their on-boarding ?
• What are the types of data and formats you need to handle now and in the future ?
• How to future-proof your system to cope with an ever-shifting and complex environment ?
• What do you need to consider to guarantee data security ?

Adents is a software specialist of unique product identification and traceability helping pharmaceutical companies and contract manufacturers to adapt to market changes and comply with regulations on drug traceability. Adents Pharma Suite utilizes user friendly, standardized software compatible with both information systems (ERP, MES) and existing production and packaging equipment. Easily upgradable, the software is designed to address both current and emerging regulations to help pharma companies remain in compliance long term.

Founded in 2007, Adents operates in Europe, Canada, and in the United States.

IT Challenges Café

How to handle individual process requirements in a standardized TT solution interface environment?

• Dealing with different roles of one company: What are requirements down the supply chain and up to the customer?
• How to set up the internal organization to define supplier requirements, include internal IT & plants and meet customer needs?
• How to organize technical interface adjustments to ensure sufficient data exchange along the entire supply chain?
• Individual standardization: How to handle the multitude of variants resulting from ongoing adjustment?
• How to achieve increasing efficiency in process and performance from roll-out to roll-out?

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients.

Our product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the medical devices for administering these products. Within transfusion technologies, Fresenius Kabi offers products for collection and processing of blood components and for therapeutic treatment of patient blood by apheresis systems.

In 2016 the company reported sales of €6 billion. Fresenius Kabi AG is a wholly owned subsidiary of the Fresenius SE & Co. KGaA healthcare group.

World Café

Data, Compliance and Verification - Are you sure you are in compliance?

• Can you verify that your data is correct?
• Do you know how to verify your data?
• Could you pass an audit?

rfXcel provides SaaS (Software as a Service) based solutions that enable pharmaceutical companies to quickly meet their serialization, traceability, and compliance needs.

rfXcel offers private-cloud solutions which are fully validated and controlled by their customers who manage “what”, “how” and “when” changes are deployed.  As one of the first and longest-lasting providers in this space, rfXcel delivers the most robust features to the pharmaceutical industry and is committed to providing standards-based, open-solutions that integrate with all trading partners, governmental agencies and end customers.

www.rfxcel.com

World Café

Requirements for Effective Project Management

• How do present benefits and engage stakeholders?
• How to ensure high level of deliverable, skill set required to deliver as planned?
• Key factors to measure project success
• Means of communicating artifacts, progress, issues, deliverable etc.

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people at Sanofi are dedicated to make a difference on patients’ daily life, wherever they live and enable them to enjoy a healthier life.

www.sanofi.com

World Café

Update on the EU Falsified Medicines Directive Requirement by 2019

• How do you keep track of global guideline developments on falsified medicines, e.g. FMD in EU, requirements in Brazil, Russia etc. and how to find synergies in their operative implementation?
• Which regulatory strategy do you choose to enable implementation of the safety features required by EU FMD?
• How do you handle the situation in case on-boarding to the EU Hub is not yet possible and that national verification systems are not set up in many countries?
• Do you expect a delay in the overall implementation timeline for the FMD safety feature requirements and if yes, are you actively pushing for this?
• How do you deal in cooperation with CMOs? Do you take over their serialization approach or do you want them to follow your company’s approach?

The Grünenthal Group is an entrepreneurial, science-based pharmaceutical company specialized in pain, gout and inflammation.
Our ambition is to deliver four to five new products to patients in diseases with high unmet medical need by 2022 and become a €2 billion company.
We are a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients. By sustainably investing in our R&D above the industrial average, we are strongly committed to innovation.
Grünenthal is an independent, family-owned company headquartered in Aachen, Germany. We are present in 32 countries with affiliates in Europe, Latin America and the US. Our products are sold in more than 155 countries and approx. 5,500 employees are working for the Grünenthal Group worldwide. In 2016, Grünenthal achieved revenues of approx. € 1.4 bn.

Case Study

Setting up an overall project organization for Serialization & T&T implementation projects: Means and Methods for actively undertaking anti-counterfeiting measures.

• What is going on at Grünenthal – Company Introduction
• Setting up a Project Governance
• Setting up a Global Serialization, Track&Trace Solution
• Project hurdles and early starter challenges
• Current Project status

AND

World Café

Update on the EU Falsified Medicines Directive Requirement by 2019

• How do you keep track of global guideline developments on falsified medicines, e.g. FMD in EU, requirements in Brazil, Russia etc. and how to find synergies in their operative implementation?
• Which regulatory strategy do you choose to enable implementation of the safety features required by EU FMD?
• How do you handle the situation in case on-boarding to the EU Hub is not yet possible and that national verification systems are not set up in many countries?
• Do you expect a delay in the overall implementation timeline for the FMD safety feature requirements and if yes, are you actively pushing for this?
• How do you deal in cooperation with CMOs? Do you take over their serialization approach or do you want them to follow your company’s approach?

The Grünenthal Group is an entrepreneurial, science-based pharmaceutical company specialized in pain, gout and inflammation.

Our ambition is to deliver four to five new products to patients in diseases with high unmet medical need by 2022 and become a €2 billion company.

We are a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients. By sustainably investing in our R&D above the industrial average, we are strongly committed to innovation.

Grünenthal is an independent, family-owned company headquartered in Aachen, Germany. We are present in 32 countries with affiliates in Europe, Latin America and the US. Our products are sold in more than 155 countries and approx. 5,500 employees are working for the Grünenthal Group worldwide. In 2016, Grünenthal achieved revenues of approx. € 1.4 bn.

Now a Certified B Corporation, OPTEL is a leading multinational provider of traceability systems, and its mission is to use its innovative technologies to create a better world through responsible capitalism. The company’s renowned solutions ensure the quality of consumer health products and help stop counterfeiting of pharmaceuticals and medical devices throughout the world. OPTEL is also adapting its technologies to create efficiencies in various other sectors ─ from health-related industries to smart manufacturing and more, all can benefit from global traceability. OPTEL’s expertise will allow diverse industries to measure, inspect, control and track a variety of elements to improve quality and make better use of resources.

www.optelgroup.com

Case Study

Setting up an overall project organization for Serialization & T&T implementation projects: Means and Methods for actively undertaking anti-counterfeiting measures.

• What is going on at Grünenthal – Company Introduction
• Setting up a Project Governance
• Setting up a Global Serialization, Track&Trace Solution
• Project hurdles and early starter challenges
• Current Project status

AND

World Café

Update on the EU Falsified Medicines Directive Requirement by 2019

• How do you keep track of global guideline developments on falsified medicines, e.g. FMD in EU, requirements in Brazil, Russia etc. and how to find synergies in their operative implementation?
• Which regulatory strategy do you choose to enable implementation of the safety features required by EU FMD?
• How do you handle the situation in case on-boarding to the EU Hub is not yet possible and that national verification systems are not set up in many countries?
• Do you expect a delay in the overall implementation timeline for the FMD safety feature requirements and if yes, are you actively pushing for this?
• How do you deal in cooperation with CMOs? Do you take over their serialization approach or do you want them to follow your company’s approach?

The Grünenthal Group is an entrepreneurial, science-based pharmaceutical company specialized in pain, gout and inflammation.

Our ambition is to deliver four to five new products to patients in diseases with high unmet medical need by 2022 and become a €2 billion company.

We are a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients. By sustainably investing in our R&D above the industrial average, we are strongly committed to innovation.

Grünenthal is an independent, family-owned company headquartered in Aachen, Germany. We are present in 32 countries with affiliates in Europe, Latin America and the US. Our products are sold in more than 155 countries and approx. 5,500 employees are working for the Grünenthal Group worldwide. In 2016, Grünenthal achieved revenues of approx. € 1.4 bn.

Case Study

It always starts with one plant – What can big companies learn from SMEs?

• Counting the Business Case and drafting a project roadmap
• Developing the environment: scaling not only the solution but also IT
• Implications for the overall strategy: Proceed according to limited resources
• Traps and pitfalls

Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with psychiatric and neurological disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company’s products are targeted at disease areas such as depression, schizophrenia, Parkinson’s disease and Alzheimer’s disease.

According to the World Health Organization, WHO, more than 700 million cases of psychiatric and neurological disorders are reported every year. These are serious and life-threatening diseases that affect the quality of life of the patients as well as of their relatives.

As these diseases also involve major socio-economic costs, it is imperative for the general society that new and innovative pharmaceuticals are developed. Over the past 50 years, new pharmaceuticals have revolutionised the treatment options, but there remains a large unmet need for new and innovative therapeutics.

Focus on R&D is the most important pillar in Lundbeck’s ambition to improve treatment for people living with psychiatric and neurological disorders. We are specialists in our area and have research facilities in Denmark and China, and more than 1,000 employees work in our R&D units. We cooperate closely with strategic partners all over the world, ensuring the best possible foundation for innovation and the development of new treatment solutions.

Lundbeck employs approximately 5,300 people worldwide, 1,700 of whom are based in Denmark. We have employees in 55 countries, and our products are registered in more than 100 countries. We have production facilities in China, Denmark, France and Italy and research centres in Denmark and China.

Advisory Board

AND

Challenge Your Peers

How to convert the burden of T&T into a benefit by making use of Big Data?

• Data is the new world currency, its usage the business driver of the future
• T&T creates tons of serialization data … and even more metadata
• Ideas & concepts to use such data, e.g. in manufacturing performance control

World class through Efficiency & Transparency

Integrated processes, from shop to top floor, from planning to distribution, is a strategic objective but yet remains a major challenge for most companies in the regulated industry. Full benefits cannot be achieved by just installing alone a system for process control. To reach that full potential – situational analysis, specifically tailored concepts and efficient implementation strategies must be developed in close alignment with the company’s organisation, associated culture and established processes.

We at prime4services actively engage and support your organisation to realise the maximum use and optimal potential across all processes and company levels. With our agile and innovative approach we ensure an optimal and efficient implementation of projects.

Use our skills and rich experience for your benefit!

Our methodology-based approach brings together processes, technologies and people. This holistic approach leads to a solution that makes optimal use of both existing and new systems / resources – neutral and vendor-independent.

Solution Study

Fast-Track T&T implementation into Shop Floor – prepare / deliver / start

• Harmonized T&T units and leveraged FAT/SAT/IQ/OQ testing
• Fast-Track qualification approach A: avoid duplication of tests, merging FAT, SAT and IQ/OQ
• Fast-Track qualification approach B: buffer environment
• Prerequisites on supplier side
• Achieved benefits

The Aenova Group is global leader in the pharmaceutical and healthcare industries. Competence and experience are the key factors for our success. With an emphasis on innovative technologies and high quality standards, we are a reliable partner for the pharmaceutical and healthcare industry.
Aenova is one of the leading contract manufacturers in Europe (CDMO). The range of services comprises the entire value chain for the development and manufacture of all main dosage forms (solid, semi-solid, and liquid) and product groups for medicines and dietary supplements.
Aenova provides a full service for customers from industry and commerce that covers everything from product development, raw material procurement, production, and analytics right up to packaging and logistics.
High standards of quality, innovative technologies, and a clear focus on the future ensure the continuing success and dynamic growth of the Group. We make long-term investments in the development of new products and the improvement of our production processes. At the same time, we are able to flexibly and rapidly react to changing requirements from customers and markets. Thanks to this strategy, Aenova ensures its long-term competitiveness and continuously increases its market share.
The Group operates 27 sites in nine European countries, Asia and the USA. 12 of our sites and our company headquarters are located in Germany. More than 4,400 employees contribute to our success.

www.aenova-group.com

Case Study

Real World key requirements for successfull Serialization Projects – Overcoming stumbling stones for establishing flexible project management structures.

• Serialization projects from scratch: How to turn from completely new to the industry to well established and standard procedure
• Overcoming the challenge of the changing internal and external requirements and adjusting project organization to meet compliance standards on time.
• Keeping the focus on the overall organization and handing over the project to Line of business

Xellia is a specialty pharmaceutical company focused on providing important anti-infective treatments against serious and often life-threatening infections. Our anti-infective treatments are generics that combat serious bacterial and antibiotic resistant infections as well as certain fungal diseases.

Ownership: Xellia is wholly owned by Novo A/S since 2013 and headquartered in Copenhagen, Denmark.

Production Sites: Five state-of-the-art manufacturing facilities located in; Denmark, Hungary, China and in the U.S. Xellia’s Finished Dosage Form facilities are located in Denmark and the U.S.

Expertise: Xellia has over 100 years’ experience in the development, manufacture and supply of generic fermented and semi-synthetic Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs). Xellia is the leading supplier of important anti-infectives Vancomycin and Colistimethate Sodium (CMS).

Customers: Xellia’s generic anti-infective business is built to meet the immediate and long-term requirements of our customers comprising branded, specialty and generic pharmaceutical companies in more than 70 countries around the world.

Innovation: Xellia is developing novel antibiotics effective against resistant species in partnership with SINTEF Materials and Chemistry and the Statens Serum Institut of Denmark, supported by a grant from the Research Council of Norway.

Compliance: We operate according to current Good Manufacturing Practice (cGMP) and our facilities have received regulatory approval from all relevant authorities, including the U.S. Food and Drug Administration (FDA).

www.xellia.com/#!start

Solution Study

Validating and Protecting Pharma 4.0 Manufacturing Processes

• Industry 4.0 and the Smart Factory – Benefits come with various cyber threats.
• Industrial Control Systems (IC S) and how it must function for pharma4.0 manufacturing.
• Consequences of unauthorized changes to manufacturing process from contaminated products, over months of re-validations to heavy financial losses.
• Major challenges of global pharmaceuticals manufacturers in connection with cyber security.
• Review on drivers for the selection and implementation of an industrial cyber security solution.
• Best practices for driving increased security and validating pharma manufacturing processes.

Indegy protects industrial control networks against operational disruptions caused by Cyber Threats, Malicious Insiders and Human Error, and ensures operational safety, continuity and reliability, by providing real-time visibility and control. The Indegy platform delivers unparalleled visibility into the critical control-plane of ICS networks to identify threats that put industrial automation controllers (PLCs, RTUs, DCS) and the processes they manage at risk. It maintains a comprehensive asset inventory and captures all changes to these assets, whether performed by malware or human, and whether authorized or not.

Closing Keynote

Security & Privacy in connected systems like Industry 4.0 manufacturing facilities

• Secure Connection for the Smarter World
• Why Trust is Key in IoT / Industry 4.0
• Possible solutions -  a holistic view
• European regulations
• Managing risk & cost

NXP Semiconductors N.V. enables secure connections and infrastructure for a smarter world, advancing solutions that make lives easier, better and safer. As the world leader in secure connectivity solutions for embedded applications, NXP is driving innovation in the secure connected vehicle, end-to-end security and privacy and smart connected solutions markets.

Now a Certified B Corporation, OPTEL is a leading multinational provider of traceability systems, and its mission is to use its innovative technologies to create a better world through responsible capitalism. The company’s renowned solutions ensure the quality of consumer health products and help stop counterfeiting of pharmaceuticals and medical devices throughout the world. OPTEL is also adapting its technologies to create efficiencies in various other sectors ─ from health-related industries to smart manufacturing and more, all can benefit from global traceability. OPTEL’s expertise will allow diverse industries to measure, inspect, control and track a variety of elements to improve quality and make better use of resources.

www.optelgroup.com