1st PDA Europe Annual Meeting

The Parenteral Drug Association presents:

T H E F U T U R E I N I N J E C T A B L E S

2016

27 June - 1 July 2016 Estrel Hotel Berlin

Berlin | Germany

Gold SponsorPlatinum Sponsor

M E E T I N G G U I D ERoundtables | Conference | Exhibition | Education Program

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Silver Sponsor Media Partner

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WELCOME FROM THE CHAIR

Dear Friends, Colleagues, Collaborators and Peers,

Welcome to Berlin and PDA Europe’s first Annual Meeting The Future in Injectables!

This meeting was carefully developed to provide you with a first-hand opportunity to stay current and anticipate future advances in modern sterile manufacturing and quality oversight. The Scientific Program Planning Committee has worked hard to offer you a very unique program with new and exciting topics specifically aimed at reflecting innovative approaches and cutting edge technologies.

Renowned industry leaders and international regulators will share their experience with you in daily plenary sessions and a series of parallel tracks. The opening plenary session will focus on strategies developed by partakers in healthcare to strive in the context of globalization and rapid scientific innovation. Concurrent sessions are designed to address many of the current challenges our industry and regulators faces. They will feature over thirty presentations with practical examples and case studies, and offer the perfect blend of industry updates, educational topics, technical advances and trends in regulatory oversight. We will dive deeply into continuous manufacturing, flexible facilities, modern analytical technologies, automation and robotics, blow-fill-seal technology, big data processing and ‘industry 4.0’, serialization and product tracking implementation, data integrity, innovative injection devices, and – last but not least – the related regulatory aspects. The conference will conclude with an outlook to the future of our industry, covering facilities, manufacturing and therapies of the future in a global context.

Opportunities to interact with speakers, industry peers, regulators, exhibitors and PDA leadership will be plenty. They include extended networking breaks, interactive roundtable discussions with PDA chapters from Europe and Japan and a very special European networking reception on the evening of June 28th.

As an extended offer, on June 30th and July 1st PDA Europe will be hosting several in-depth training courses that are designed to complement topics presented at the conference.

PDA Europe’s first Annual Meeting The Future of Injectables shows once again PDA’s commitment to bringing manufacturing technology advances to the forefront and facilitating discussions between industry, suppliers and regulators. You will leave the conference richer, both in terms of knowledge and relationships, which will benefit your career and organization.

On behalf of the program planning committee and PDA staff, wish us all a week filled with fruitful discussion and continuous learning through professional interaction and exchange of ideas!

Welcome to Berlin!

Ursula Busse, PhD MBA, Novartis Group Quality Conference Chairwoman

Activities at a Glance 4

Roundtable Discussions 6

Conference 8Networking Event 11

Poster Session 15

Floor Plan 17

Exhibitor Abstracts 18

PDA Education Program 25Test Methods for Pre-filled Systems 26

Cleaning and Disinfection 28

How to Find the Right GMP for APIs 30

Root Cause Investigation for CAPA 32

Development and Manufacturing of Pre-filled Syringes 34

Information 38PDA Social Media Guide 39

Table of Contents

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ACTIVITIES AT A GLANCE

Tuesday, 28 June8:00 - 18:00Registration Hours

9:00 - 18:30Conference Day 1 3 Tracks A, B, C

Rooms A, B, C

14:00 - 16:00EU Exhibition Committee Meeting (by invitation only)

Room 30241

19:00 - 22:30PDA Europe Networking Event "Summer in Berlin" Pier 13 Restaurant & Bar, Tempelhofer Damm 227, 12099 Berlin

Meeting Point for Bus Shuttle: Hotel Estrel - PDA Registration Desk

Thursday, 30 June7:30 - 12:00Registration Hours Education & Training

9:00 - 17:30How to Find the Right GMP for APIs One-Day Training Course

Room 30212

9:00 - 18:00Root Cause Investigation Training Course, Day 1

Room 30241

9:00 - 17:45Development and Manufacturing of Pre-filled Syringes Workshop, Day 1

Room Paris

13:00 - 14:00Open House PDA Europe Office Visit Am Borsigturm 60 13507 Berlin (by invitation only)

9:00 - 17:00Test Methods for Pre-filled Syringe Systems One-Day Training Course

Room Lyon

9:00 - 18:00Cleaning and Disinfection One-Day Training CourseRoom 30210

Wednesday, 29 June8:00 - 17:00Registration Hours

8:00 - 9:00Morning Roundtables PDA Chapters Italy, France, UK

Room A

7:00 - 8:00Orientation Breakfast (by invitation only)

Room Paris

8:00 - 9:00Morning Roundtables PDA Chapters Ireland, Israel, Japan

Room B

9:00 - 17:30Conference Day 2 3 Tracks A, B, C

Rooms A, B, C

8:00 - 9:00Interest Group Meeting TechTransfer

Room C

Monday, 27 June8:00 - 17:00Exhibition Set-up

8:00 - 18:00Registration Hours

13:30 - 15:30Roundtable Discussion Business Opportunities India

Room 30241

16:00 - 18:00Roundtable Discussion Business Opportunities Iran

Room 30241

17:00 - 18:00Chapter Council Meeting (by invitation only)

Room Paris

18:00 - 20:00Welcome Reception “Willkommen” to Berlin

Biergarten - Terrace by the river Spree

Friday, 1 July8:00 - 12:00Registration Hours Education & Training

9:00 - 16:30Root Cause Investigation Training Course, Day 2

Room 30241

8:30 - 16:45Development and Manufacturing of Pre-filled Syringes Workshop, Day 2

Room Paris

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1 Ursula Busse, Conference Chair, Novartis

2 Jette Christensen, Novo Nordisk

3 Véronique Davoust, Pfizer

4 Derek Duncan, LIGHTHOUSE

5 Gabriele Gori, GSK Vaccines

6 Eric Meier, Novartis

7 Stephan Rönninger, Amgen

8 Mihaela Simianu, Consultant

9 Ryan Smith, SightMachine

10 Jochen Strube, Clausthal University of Technology

11 Sylvia Becker, PDA Europe

12 Georg Roessling, PDA Europe

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S C I E N T I F I C P R O G R A M P L A N N I N G C O M M I T T E E

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altran.de

Competences Quality & Regulatory Compliance

Process Engineering

Smart Manufacturing

Life Science Digitalisation

Innovative Medical Solution Development

Your end-to-end partner

for Industrial Performance

and Compliance in

LIFE SCIENCES

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ROUNDTABLE DISCUSSIONS

Monday, 27 June

Room 30341

Business Opportunities India Moderator: Georg Roessling, PDA Europe

13:30 Indo-German Economic Relations: Missed Opportunities Sushil Khanna, University Calcutta, Visiting Professor in Leipzig

Business Opportunities India Joerg Strassburger, Go East, Advisors for Emerging Markets

Yvonne Metzger, Bundesverband mittelständische Wirtschaft - The German Association for Small and Medium-sized Businesses

Q&A, Discussion with Exhibitors and Conference Participants

15:30 End of Business Opportunities India

Business Opportunities India

Business Opportunities IranRoom 30341

Business Opportunities Iran Moderator: Georg Roessling, PDA Europe

16:00 Please join the roundtable discussion on the current situation of the pharmaceutical industry in Iran. Topics of discussion will be:

• Regulatory Environment of the Iranian Pharmaceutical Industry

• Modernisation Needs of the Pharmaceutical Industry

Akbar Abdollahiasl, General Director of Pharmaceutical Affairs, Ministry of Health, Iranian FDA

Zohre Bazaz, Inspector, Iranian FDA

Q&A, Discussion with Exhibitors and Conference Participants

18:00 End of Business Opportunities Iran

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ROUNDTABLE DISCUSSIONS

Business Opportunities Iran

Business Opportunities IndiaYvonne Julia Metzger, CEO, markets and more

Yvonne Julia Metzger, M.A., is founder and CEO of markets and more, General Manager BVMW India and official representative of BVMW e.V. (Bundesverband für mittelständische Wirtschaft) in the metropolitan region Hamburg. As CEO of markets and more, she works for several companies as Sales Manager, CRM and Marketing Manager, speaker and trainer. markets and more is specialized in developing and implementing marketing strategies and finding sales partners for companies in Germany, Europe and India with focus on biotech, medical and pharma industry. Yvonne Julia Metzger has more than ten years of international experience in marketing, sales and event

management. She has built up and guided the department for sales and marketing at one of the leading laser fiber manufacturers in Germany. Prior to that, she worked as project manager at the German-Dutch Chamber of Commerce in The Hague and in a market research company.

Joerg Strassburger, CEO, Go East Advisors

Dr. Joerg Strassburger is the Founder and CEO of Go East Advisors. With offices in Germany and India, the company is supporting Europe-an chemical companies in their business development in Asia with a strong focus on the Indian market. Besides strategy development and strategy implementation to achieve stronger business growth in India, he and his partner identified India as an attractive sourcing market for chemical intermediates. Purchasing services range from spot purchasing of mineral fillers to the establishment of contract manufacturing agreements for pharmaceutical intermediates. Go East Advisors’ business portfolio also includes identifying the right

partners to establish long-term partnerships, JV’s or Acquisitions between Indian and European chemical companies. Before founding Go East Advisors, Dr. Strassburger was the Country Representative and Managing Director of LANXESS India Private Limited from 2005 to 2014. He was responsible for the oper-ations and development of LANXESS' business units in India. Before this assignment, Dr. Strassburger was head of Corporate Development at LANXESS AG, and was actively involved in developing LANXESS' global strategy.

Akbar Abdollahiasl, General Director of Pharmaceutical Affairs, Ministry of Health, Iran

Dr. Abdollahiasl is General Director of Pharmaceutical Affairs in Iran's Ministry of Health and assistant professor in Tehran University of Medical Sciences. He is a pharmacist and PhD of Pharmacoeconomics and Pharmaceutical Administration. While working in the phar-maceutical fields, he’s had the responsibility of management of medicinal supply chain, medical and pharmaceutical data analysis, pricing of pharmaceutical products and planning of NRA systems as well as the Head of Statistic and Planning Office in Iran Food & Drug administration. He has directed more than 20 research projects trying to find a system dynamics model for national drug policy and on

subjects such as Iran medicine’s prices, availability, affordability and price components (in corporation with HAI), essential medicines and pharmaceutical policies unit, pharmaceutical education in Iran and cost of different illnesses in Iran. He’s participated in some courses like Health Sector Reform course offered by American University of Beirut (2003-2004), Pricing and Reimbursement course offered by Vienna School of Clinical Researches (2005) and some MIS and data mining courses. He is one of the key opinion leaders of pharmaceutical fields in Iran.

Speaker Biographies

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CONFERENCE AGENDA

Tuesday, 28 June

9:00 Welcome: Opening Remarks, Introduction & PDA Awards Georg Roessling, PDA Europe Ursula Busse, Novartis, Conference Chair

Opening Plenary Moderator: Ursula Busse, Novartis

9:15 The Quality Journey: From Good to Great Martin van Trieste, Amgen

9:45 A Question of Trust – Hard Won, Easily Lost John Johnson, NSF Health Sciences

10:15 Overcoming the Divide of Excellence & Quality Thomas Friedli, University of St. Gallen

10:45 Coffee Break, Poster Session & Exhibition

11:15 Regulatory Considerations for Continuous Manufacturing: EU Perspective

Jean-Louis Robert, European Medicines Agency, Chair of the CHMP/CVMP Quality Working Party

11:45 The International Role of PIC and PIC/S in Harmonizing Inspections Paul Hargreaves, MHRA, PIC/S

12:15 Q&A, Discussion

12:45 Lunch Break, Poster Session & Exhibition

13:40 Transition to Parallel Tracks

P A R A L L E L T R A C K S

Rooms A B C

TRACK A TRACK B TRACK CSession 1 Continuous Manufacturing

& Flexible Facilities TestingLifecycle Management

and Innovation:Are they Mutually Exclusive?

The Future in InjectablesDigital Version

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CONFERENCE AGENDA

Moderators: Mihaela Simianu, Consultant Jette Christensen, Novo Nordisk Ursula Busse, Novartis

Session 1 Continuous Manufacturing& Flexible Facilities Testing

Lifecycle Management and Innovation:

Are they Mutually Exclusive?

13:45 Concepts and Solutions for Continuous Manufacturing

Eric Meier, Novartis

Attribute Focus to Achieve the Quality Target Product Profile (QTPP)

Rohini Deshpande, Amgen

Challenges of Pharma Industry with Lifecycle Approach

Anders Vinther, Sanofi Pasteur

14:15 Process Development and Engineering Challenges for Future Manufacturing of Biologics

Jochen Strube, Clausthal University

Post Approval Lifecycle Manage-ment of Analytical Control Systems

Emma Ramnarine, Genentech / Roche

From QbD to Lifecycle Management: Regulatory Perspective of Guide-lines that should Encourage Innovation - Opportunities and Challenges

Jean-Louis Robert, European Medicines Agency, Chair of the CHMP/CVMP Quality Working Party

14:45 Traceability in Continuous Manufacturing

Jochen Thies, Glatt Group

All-in-One Solution for Parenteral Containers CCI Testing and Headspace Gas Verification

Andrea Simonetti, Bonfiglioli Engineering

Recent Initiatives put Forward by the WHO to Facilitate Post-Approval Change Management for Vaccines

DianLiang Lei, World Health Organization

15:15 Q&A, Discussion Q&A, Discussion Q&A, Discussion

15:45 Coffee Break, Poster Session & Exhibition

P A R A L L E L T R A C K S

Rooms A B C

TRACK A TRACK B TRACK CSession 2 Automation & Robotics Testing Blow-Fill-Seal

Moderators: Masahiro Akimoto, Otsuka Pharm. FactoryStephan Rönninger, Amgen

Jette Christensen, Novo Nordisk Georg Roessling, PDA Europe

16:15 Nanoparticle Technology in Pharmaceutical Applications

Sanshiro Nagare, Nara Machinery

Testing of Final Product during Scale Up: Lessons Learned

Derek Duncan, LIGHTHOUSE

Pre-filled Syringes made by Blow-Fill-Seal

Rajeev Kabbur, Brevetti Angela

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CONFERENCE AGENDA

Session 2 Automation & Robotics Testing Blow-Fill-Seal

Moderators: Masahiro Akimoto, Otsuka Pharm. FactoryStephan Rönninger, Amgen

Jette Christensen, Novo Nordisk Georg Roessling, PDA Europe

16:45 A New Generation Packaging Line for Filled Product in Carton with Integrated Dividers

Hiroaki Mizuno, Omori Machinery

CCIT Technology on BFS Containers: From the High Speed Testing Prospective, the Testing Reliability and the Validation Approach

Jaime Cobo, Wilco

Basic Principles and Regulatory Requirements for BFS Technology including Qualifications and Validation Aspects

Christoph Bohn, Holopack Packaging Technology

17:15 Overview of the Low Voltage Electron Beam Sterilization System and its Benefits

Koji Kawasaki, AirEX

In-Line Automated Visual Particle Inspection of BFS Containers for Injectable Drug Products

Heino Prinz, rommelag

Specific Aspects for Manufacturing and Autoclaving of BFS Products

Martin Haerer, Holopack Packaging Technology

17:45 Moderator:Masahiro Akimoto, Otsuka Pharm. Factory

Roundtable DiscussionBusiness Opportunities Japan

Session Speakers

Moderator:Gabriele Gori, GSK Vaccines

Roundtable Discussion Final Product Control:CCIT & Visual Inspection– Do we need it? What will Annex 1 bring?

Session Speakers

Experience with Filling of Biological Products with Cool BFS Technology

Otto Schubert, Maropack

18:30 End of Day 1

19:00 Joint Departure & Networking Event @ Pier13

Summer in BerlinNetworking Event

The Parenteral Drug Association presents:

Meeting Point: Hotel Estrel - PDA Registration Desk

Shuttle Bus leaving at 19:00hShuttle Bus returning to the Estrel Hotel 22:30hDress Code: Casual Summer Look

Please confirm your attendance at the PDA Registration Desk. If you have any dietary requirements, please let us know.

Pier 13 | Tempelhofer Damm 227 | Tempelhofer Hafen | 12099 Berlin

SPECIAL ACT:

HEAR THE FIRST PDA BAND PLAYING.

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CONFERENCE AGENDA

Wednesday, 29 June

7:30 Welcome Coffee

M O R N I N G R O U N D T A B L E S

8:00 MEET THE PDA CHAPTERS

PDA has 24 Chapters around the world with local programs and resources to help you stay informed, interact with your peers, and facilitate exchange with the pharmaceutical and biopharmaceutical industry. Meet six of these chapters in this morning session and get to know the chapter presidents and industry peers in your region!

ROOM A ROOM B

ITALY / SWITZERLAND FRANCE UK IRELAND ISRAEL JAPAN

I N T E R E S T G R O U P M E E T I N G , T E C H T R A N S F E R ( T T I G )

8:00Room C

• Scope and Activities• Technical Report #65• TT IG current picture

- Membership, Geographic distribution, Expertise onboard

• Goals for 2016 & Next steps• Q&A, Discussion

IG Leader:Mirko Gabriele, Patheon

P A R A L L E L T R A C K S

Rooms A B C

TRACK A TRACK B TRACK CSession 3 Big Data Processing / Industry 4.0 Regulatory Track Technical Track

Moderators: Georg Roessling, PDA Europe Jette Christensen, Novo Nordisk Mihaela Simianu, Consultant

9:10 Industry 4.0 - Readiness for Pharmaceutical Companies

Andreas Traube, IPA Fraunhofer Institute

What an Inspector Needs to Know About Assessment

Kevin O’Donnell, Health Products Regulatory Authority, Ireland (HPRA)

Serialization Requirements in Europe

Véronique Davoust, Pfizer

9:40 Industry 4.0: How to Identify and Use Key Enabling Technologies – Demonstration by Case Studies

Francisco Jose Herrador Jorro, Altran

Challenges in Pharmaceutical Industry-SME Perspective

Andreas Sachse, CPL SACHSE

Serialization and Product Tracking Implementation in a Global Environment

Michael Ritter, Novartis

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CONFERENCE AGENDA

Session 3 Big Data Processing / Industry 4.0 Regulatory Track Technical Track

10:10 Manufacturing & Big Data: Approaches for Pharma

Toni Manzano & Pep Gubau, BigFinite

Import of Pharmaceutical Products: Annex 21, OECD Guideline

Stephan Rönninger, Amgen

Track and Trace Implementation in Iran

Akbar Abdollahiasl, IFDA

10:40 Q&A, Discussion Q&A, Discussion Q&A, Discussion

10:55 Coffee Break, Poster Session & Exhibition

11:25 Transition to Parallel Tracks

P A R A L L E L T R A C K S

Rooms A B C

TRACK A TRACK B TRACK CSession 4 Modern Analytical Techniques Data Integrity Drug Administration

Moderators: Derek Duncan, LIGHTHOUSE Stephan Rönninger, Amgen Eric Meier, Novartis

11:30 Predictive Modelling and Real-time Analytics Applied to Fill and Finish Operations

Cenk Undey, Amgen

DI – A Criminal Act? Overview, Clarification, Definition

Anil Sawant, Merck & Co.

Innovative Drug Delivery

Ian Thompson, Ypsomed Delivery Systems

12:00 Digital Transformation for Biotech-nology: A Big Data Approach to Manufacturing Analytics

Ryan Smith, SightMachine

Data Integrity for Computer Systems – A Bumpy Road to Compliance

Wolfgang Schumacher, Roche

Smart Medication–Where Electronics meet Drug Delivery

Markus Bauss, SHL Connect

12:30 Automated Media Fill Inspection

David Brueckner, Roche

Data Integrity – A Holistic Approach

Madlene Dole, Novartis

Best Practice in Glass Handling During Device Development and Commercialization

Thomas Schoenknecht, SHL Medical

13:00 Q&A, Discussion Q&A, Discussion Q&A, Discussion

13:15 Lunch Break, Poster Session & Exhibition

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CONFERENCE AGENDA

Session 5 : Closing Plenary - Future Developments Moderator: Ursula Busse, Novartis

14:15 Past & Future of Injectable Dosage Forms for Biologics – Quo vadis, Parenteralia?

Hanns-Christian Mahler, LONZA

14:45 Needs and Possibilities of New Manufacturing and Facility Design Maik Jornitz, G-Con Manufacturing

15:15 Requirements and Opportunities for the “Parenteral Facility of the Future”

Morten Munk, NNE Pharmaplan

15:45 Coffee Break, Poster Session & Exhibition

16:15 Challenges for Medical Treatment in Future Samvel Azatyan, World Health Organization

16:45 Panel Discussion: The Future of Injectables

In this panel discussion, we want to focus on the future of manufacturing, application of injectables and regulatory aspects.

Some of the questions to be discussed are:• How innovative is the pharmaceutical industry?

• What are hurdles for innovation and what can contributions from technology and regulatory bodies be?

• How will new application concepts help patients?

• Will the future see one global dossier and one harmonized inspection system?

• What can ICH, WHO and PIC / S contribute?

Participants:Samvel Azatyan, World Health Organization

Paul Hargreaves, MHRA and Chair of PIC / S

Steven Lynn, Novartis (and former FDA)

Hanns-Christian Mahler, Lonza

Martin van Trieste, Amgen

17:30 Closing Remarks, End of Conference & Farewell Coffee

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During all coffee and lunch breaks, you have the opportunity to visit the Poster Session located in the Exhibition Area.

Poster presenters will be happy to welcome you and answer your questions.

Shlomo Sackstein, Biopuremax

Biopuremax- Pre-Treatment Water System

Róbert Lehocky, University of Chemistry and Technology, Prague

Enzymatic dissolution method for poorly soluble API in injectables depot administration

Daniel Pěček, Zentiva

Ball Milling Preparation of Sustained Release Suspension for Intramuscular Administration

Danilo Maruccia, PQE

Data Integrity Challenge:The Infrastructure Technology Lifebelt

Paul Lopolito, STERIS Corporation

A Scientific Approach to Maintaining your Stainless Steel Surfaces

POSTER SESSION

Elizabeth Rivera, STERIS Corporation

Cleaning Validation Concerns for Continuous Manufacturing

Christa Jansen-Otten, West Pharmaceutical Services

Component Selection Strategies for PFS: Risk Mitigation, Performance and Larger Injection Volume Driving Innovative Solutions

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Global Pharmaceutical Solutions

Sensitive biopharmaceuticals? We take the challenge

• Drug delivery solutions & technologies for injection and infusion

• Expert platforms in pharmaceuticals, polymers, coatings, precision and miniaturization technologies

• Uncompromised Quality and Regulatory Affairs support

• Committed to improved drug delivery and patient comfort

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PDA Registration

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FLOOR PLANESTREL HOTEL BERLIN

PDA Registration

Exhibition Stand

C: Chapter Stand

Platinum Sponsor

Gold Sponsor

Silver Sponsor

Buffet / Coffee Station

Poster Session

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Exhibitor Booth

Nara Machinery 1

Saint-Gobain 2

Veltek Associates 3

Groninger 4

Steris 5

Toxikon 6

Iwata Label 7

Novatek 8

Azbil Telstar 9

West Pharmaceutical Services 10

LIGHTHOUSE Instruments 11

Gateway Analytical 12

rap.ID 13

Altran 14

Bonfiglioli Engineering 17

Merck 19

Afton Scientific 20

NSF Pharma Biotech 21

Terumo 22

Wilco 23

PTI Inspection Systems 25

PQE 26

Watson-Marlow 27

OMORI Machinery 28

OMPI 29

biopuremax 31

Malvern Instruments 32

rommelag 37

PDA Country Chapter Booth

Italy Chapter C1

France Chapter C5

United Kingdom Chapter C3

Ireland Chapter C4

Israel Chapter C2

Japan Chapter C6

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Afton Scientific 2020 Avon Court Charlottesville 22902, VA United States Tel: +1 434 97 93 73 7 Fax: +1 434 97 93 73 8 info@aftonscientific.com www.aftonscientific.com

cGMP Processing of Sterile Products Afton Scientific

Afton is a cGMP sterile processor of pre-packaged empty sterile vials, stoppers and seals (Ready-to-Fill) to companies worldwide for im-mediate use in cGMP aseptic filling operations. These components are used not only for small clinical fills, but also for approved mar-keted injectable drugs. Afton is inspected by both the US FDA and MHRA. Aftonís customers include small biotechs, multinational phar-maceutical companies and major research institutions. Afton ships worldwide. Afton also provides cGMP contract sterile filling services of investigative new drugs, biologics and commercial injectable pharmaceuticals.

Altran Deutschland S.A.S. & Co. KG Frankfurter Ring 81 80807 - Munich Germany P: +49 89 930 800 F: +49 89 930 139 ML-DE-info@altran.com www.altran.com

With a network of 2,000 dedicated consultants in more than 15 countries, Altran delivers the highest level of expertise to over 200 customers to develop innovative medical solutions, improve their operational performance and compliance and accelerate their dig-ital transformation. Ageing population, chronic/lifestyle diseases, emerging market expansion, treatment and technology advances, together with important efforts to optimize healthcare spending, outcomes and delivery are megatrends influencing companies op-erating in the Life Sciences industry. With over 30 years of experience in Life Sciences, Altran provides adapted strategic, operational and technological innovative services and solutions to support compa-nies in all stages of the medical-product life cycle and help them address cost and regulatory pressures, growing needs for modern technologies integration across the whole value chain and a shift to outcome-based business models.

Azbil Telstar United Kingdom Unit 4, Shaw Cross Business Park Horace Waller VC Parade Dewsbury West Yorkshire WF12 7RF United Kingdom T: 44 1924 455339 0 www.telstar.eu

Engineering, construction, consulting and validation services and design, manufacture and sales of integrated process equipment solutions with in-house sterilization, freeze-drying, containment, barrier systems, production of PW, WFI, clean steam, clean air tech-nologies and automated systems for Life and Health Sciences; inte-grating knowledge and technologies to provide optimal solutions with a high added value to our customers for the pharmaceutical, biotechnology and veterinary industries and research centers.

Biopuremax HaSadnaot 4 st 46728 - Herzliya Israel P: +972 9 9716111 F: +972 9 9716112 Shlomo@biopuremax.com www.biopuremax.com

The Biopuremax is a new type of pretreatment water system for RO with no organic resins for softening, no carbon and no SBS for chlo-rine destruction. The system based on electrical scale precipitation and UV destruction of chlorine. All the system is hot water sanitized (full SS construction) It has no backwash, no regeneration and no chemical dosing. The system is revolutionary in the fact that it has no moving parts, no regenerations, no chemicals, no contamination and no waste stream. The system is reliable as it is simple, no tuning or adjustments are needed after the design and installation.

EXHIBITOR ABSTRACTS

2016 PDA Europe

Pharmaceutical Freeze Drying Technology27-28 September 2016 Strasbourg | France

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Bonfiglioli Engineering S.r.l. Via Rondona, 33 44049 Vigarano Pieve (Ferrara) Italy Tel: +39 0532 71 56 31 Fax: +39 0532 71 56 25 marketing@bonfiglioliengineering.com www.bonfiglioliengineering.com

Bonfiglioli Engineering, leader in manufacture of inspection equip-ments, has developed an advanced expertise in Container Closure Integrity Testing, Visual Inspection and Headspace Gas Analysis context, addressing both quality and safety of all container sys-tems, for Laboratory and Inline container integrity testing for lab-oratories as well as in-line container integrity testing. After over 40 years of planning and manufacturing innovation, BE prides itself on a perfect combination of production stability, testing efficiency and maintenance simplicity. The machines, custom-made to customers specifications with top quality standards and proven technologies, are built to be used in all production conditions and designed to be easily managed through intuitive interface boards and fast format changes. BE’s innovative machines are cost, time and space-effec-tive. They guarantee high quality, safe products to the end-user while protecting manufacturers from financial loss due to recalls, lawsuits and potential adverse publicity.

Gateway Analytical 5316 William Flynn Highway 15044 - Gibsonia United States P: +1 724 443 1900 F: +1 866 658-1445 lehrp@gatewayanalytical.com www.gatewayanalytical.com

Gateway Analytical is a contract analytical laboratory and consult-ing company offering the pharmaceutical, materials science and forensics industries expertise by using conventional and innovative analytical testing techniques. Gateway Analytical is FDA registered, cGMP complaint, DEA licensed, and ISO 17025 certified. We ensure that all testing is performed to provide results efficiently and effec-tively, while maintaining the highest quality standards. Gateway An-alytical is a subsidiary of ChemImage Corporation, a leader in chem-ical imaging technology and instrumentation.

groninger & co. gmbh Hofaeckerstrasse 9 74564 - Crailsheim Germany P: +49 7951 495 0 F: +49 7951 495 3138 info@groninger.de www.groninger.de

Filling and packaging machines for the pharmaceutical, consum-er healthcare and cosmetic industry. groninger is a successful, ex-perienced and dynamic company with around 1000 employees worldwide, focused on developing and manufacturing specialized machines for accurate filling and secure closing of liquid pharmaceu-tical products, especially in pre-sterilized syringes, vials and bottles. Working close with the customer, groninger develops and realizes the optimal solution for the customers' requirements! The groninger machine program ranges from: fully automated syringe processing lines with tray loading / unloading, washing, filling, gassing, piston rod insertion, checking, labeling as well as label control ñ speeds up to 60.000/h; liquid filling lines for vials and bottles including washing station, sterilization tunnel, filling, stoppering, labeling, label control as well as capping ñ speeds up to 48.000/h; eye drop filling and clos-ing lines with the latest technology and speeds up to 24.000/h; highly flexible filling and closing lines for consumer healthcare, diagnostics and other non-aseptic liquid products in plastic and glass contain-ers; isolator compatible filling machines; peripheral equipment for filling and closing lines, including container and component sorting and feeding equipment and robotic sorting and feeding solutions.

IWATA LABEL Europe Königsallee 92a 40212 - Düsseldorf Germany P: +49 211 5403 9784 toshiaki_kurihara@iwatalabel.co.jp www.iwatalabel.com

IWATA LABEL Europe GmbH is a specialty manufacturer of adhesive labels and labeling machines for pharmaceutical products. Our products add high value and multiple functions to pharmaceutical labeling needs. The need for labeling solutions, which protect medi-cal staff, greatly helps us focus on innovation and develop new prod-ucts and services.

EXHIBITOR ABSTRACTS

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LIGHTHOUSE Instruments Science Park 408 1098 XH Amsterdam The Netherlands P:+31 6 4226 7380 euinfo@lighthouseinstruments.com www.lighthouseinstruments.com

LIGHTHOUSE is the leading global provider of laser-based head-space analysis systems. Headspace applications include: 100% container closure integrity (CCI) inspection, off-line CCI testing, IPC of headspace oxygen during filling and for stability studies, lyo cy-cle optimization, lyo chamber moisture mapping, and automated media fill inspection. LIGHTHOUSE offers a range of benchtop and in-line platforms with patented laser sensor technology commer-cialized with the help of funding from the Food and Drug Adminis-tration. In addition, analytical services are delivered from laboratory facilities in Amsterdam and Charlottesville, Virginia.

Malvern Instruments Enigma Business Park, Grovewood Road Malvern WR14 1XZ Worcestershire United Kingdom Phone: +44(0) 1684 892456 Fax: +44 (0) 1684 892789 stephane.rouquette@malvern.com www.malvern.com

Malvern Instruments proposes a full range of instruments to charac-terize proteins and macromolecules:• Zetasizer, DLS & SLS for size, molecular weight, protein charge; • NanoSight NTA, concentration; • OmniSEC, molecular weight/structure;• MicroCal, binding parameters; • Viscosizer, size and viscosity.

For Visible and Sub visible particles:• The Morphologi G3ID:

An automatic microscope platform associated with Raman Spec-trometer to measure concentration, size, shape and chemical ID of particles from 1 to 1000 µm.• The Archimedes:

RMM (Resonant Mass Measurement) technique, to measure mass, concentration and buoyancy (protein versus silicon oil) of protein formulations from 0.2 to 5 µm.

Merck Frankfurter Strafle 250 64293 Darmstadt Germany Tel.: +49 (0) 6151 72-0 Fax: +49 (0) 6151 72-2000 service@merckgroup.com www.merckgroup.com

Merck a leading science and technology company in life science, offers products used by pharmaceutical and biotechnology com-panies to develop and manufacture drugs safely and efficiently. We provide excipients, APIs, complex API manufacturing services and critical raw materials to support all stages of the drug manufactur-ing process from research to industrial-scale production and quality control. Our products meet the highest purity standards with exten-sive documentation and services to assure regulatory compliance.

NARA Machinery Co., Ltd. Europaallee 46 50226 - Frechen Germany P: +49 2234 2776 0 F: +49 2234 2306 7 contact@nara-e.de www.nara-e.de

For more than 90 years supporting companies from various indus-tries all over the world with solving their challenges in matters of powder treatment. Specialized in drying, milling, mixing and particle design we believe to provide our customers and partners the best know-how to meet their expectations.

Novatek International 2537 Rue Guenette H4R 2E9 Montreal Canada P: 1-514-668-2835 F: : 1-336-6537 sales@ntint.com www.ntint.com

Novatek is regulatory compliant software provides the building blocks for a complete quality management solution that can be tailored to any clientís needs. Our software can be used as stand-alone modules or integrated with other modules to form large-scale comprehensive solutions. With 20 years of successful installations worldwide, Novatek has developed an extensive base of regulatory knowledge ensuring compliance and peace of mind during audits for our clientele. Build your solution with the flexibility to grow with your needs and implement at your pace!

EXHIBITOR ABSTRACTS

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NSF Pharma Biotech The Georgian House, 22/24 West End, Kirkbymoorside York, YO62 6AF United Kingdom Tel: +44 1751 43 29 99 Fax: +44 1751 43 24 50 pharmamail@nsf.org www.nsf.org

NSF Health Sciences Pharma Biotech is a major global provider of pharmaceutical education, consultancy, auditing and analytical testing. Our education programs include GMP courses, QP Training, Sterile Manufacture, Human Error Prevention and IRCA certified QMS auditor courses. NSF provides consultancy for GMP/GDP compli-ance, quality management systems and regulatory enforcement ac-tion support. We conduct mock regulatory inspections, supplier au-dits and certification. Our mission is to work in partnership with our clients to add value through • Improving efficiency and operational excellence through simplification of quality systems and processes • Helping companies adopt standards that are fit for purpose through benchmarking • Supporting companies in preparing for future chal-lenges (business and regulatory) to stay ahead of their competition • Educating employees to improve business performance, robustness and flexibility • Guiding companies to change their culture!

Omori Europe Eektestraat 1 7575 AP - Oldenzaal The Netherlands P: +31 541 582026 F: +31 541 520595 info@omorieurope.com www.omori.co.jp

Omori supply a wide range of state-of-the-art stretch and flow wrap-pers (HFFS) for different, creative and innovative packaging. We are a leader in the food and pharmaceutical industries. The packaging machines can be combined with different automated input systems, to provide a turnkey packaging system. The combination of high quality equipment with creative packaging solutions, gives a beau-tiful and luxurious look to your product, with distinctive character. The advanced, Japanese machines of Omori comply with the Euro-pean directives and components can be specified to suit the cus-tomerís requirements.

OMPI Via Molinella 17 35017 - Piombino Dese Italy P:+39 049 9318111 F:+39 049 9366151 info@ompipharma.com www.ompipharma.com

Ompi is the Pharmaceutical Systems division of Stevanato Group. OMPI boasts a unique expertise in providing superior pharmaceu-tical containers from glass tubing. Its comprehensive portfolio cov-ers every customer need, from those related to small molecules to highly sensitive drugs: syringes, pen and dental cartridges, injection and lyophilization vials and ampoules. Syringes, cartridges and vials are produced both in bulk and sterile format (www.ez-fill.com). Ompi EZ-fill concept is a solution that provides the pharmaceutical vials, cartridges or syringes already washed, sterilized ready to be filled by simplifying the traditional production process. Ompi also provides customized containers, all manufactured to the highest standards.

PQE Deutschand GmbH Landshuter Str. 55 85435 - Erding Germany P: +49 8122 17750 60 F: +49 8122 17750 61 de.info@pqe.eu www.pqe.eu

PQE is a Contract Quality Organisation and a Complete Quality Solu-tion provider for GCP, GLP, GMP & GDP areas in the Life Science Indus-try. Since 1998, we have successfully completed more than 10,000 projects world wide and now serve our Clients from offices in Italy, Spain, Germany, Switzerland, US, LATAM, the Middle East and China. As an international company we have experience working in more than 15 languages and have an excellent history of supporting small, medium and large size companies exceed compliance standards from the FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA and other local authorities.

EXHIBITOR ABSTRACTS

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PTI Inspection Systems 145 Main Street 10707 - Tuckahoe United States P: +1 914 337 2005 F: +1 914 337 8519 info@ptiusa.com www.ptiusa.com

PTI Inspection Systems is the leading manufacturer of non-destruc-tive package quality inspection technologies for package integrity testing, seal integrity, leak testing and container closure integrity testing (CCIT). PTI technologies include vacuum decay, airborne ul-trasound and high voltage leak detection. Our technologies are de-terministic, quantitative test methods that exclude subjectivity from package testing, and use test methods that conform to ASTM stan-dards. PTI Inspection systems provide repeatable, reliable results and can be used at any point in the manufacturing process as they are non-destructive, non-invasive and require no sample prepara-tion.

rap.ID Particle Systems GmbH Köpenicker Str. 325, Haus 11 12555 Berlin, Germany Tel: +49 30 6576 3440 Fax: +49 30 6576 3441 information@rap-id.com www.rap-id.com

rap.ID creates fully GMP compliant analysis instruments for particu-late identification and has defined the standard in pre-filled syringe lubrication control. rap.ID is the technological leader in the identifi-cation of contamination particles as it is the only company world-wide combining micro Raman and LIBS in one instrument. Using its pharmaceutical industry experience rap.ID provides contract testing and method development and validation from its FDA inspected lab-oratories in USA and Germany. With over 5.000.000 identified parti-cles within the last 14 years rap.ID became a global institution for the root cause analysis of visible and sub visible particulate matter.

rommelag ag Fabrikweg 16 5033 - Buchs Switzerland P: +41 62834 5555 F: +41 62834 5500 mail@rommelag.ch www.rommelag.com

rommelag the inventor of Blow-Fill-Seal (BFS) Technology is the worldwide leading manufacturer and supplier of bottelpack aseptic machines for the packaging of sterile liquids. The bottelpack ma-chines are cGMP and FDA compliant. bottelpack aseptic machines have an integrated clean room class A (US-class 100). The machine capacity goes up to 30,000 containers / hour with volumes from 0.1 ml to over 1,000 ml. Plastic materials used are LDPE, MDPE, HDPE, PP, PET and others. We offer tests and contract fillings in our own laboratory and production utilities. rommelag is certified according to the new standard DIN EN ISO 9001: 2000.

Saint-Gobain 11400A 47th Street N 33762 - Clearwater United States P: +1 727 540 1060 227 linda.f.potter@saint-gobain.com www.biopharm.saint-gobain.com

As one of the world's largest manufacturers of high performance materials, Saint-Gobain Bioprocess Solutions is leading the way in critical fluid management. Our Collaborative Design Services devel-op customized single-use systems tailored to your bioprocess. We are the developer and manufacturer of industry standards: C-Flex, PharmaFluor, PharmaPure, Pure-FitÆ and Sani-Tech.

EXHIBITOR ABSTRACTS

PDA Europe supports the children's hospice „Sonnenhof”

The Sonnenhof Hospice, located near PDA’s office in Berlin, offers support and assistance to families with children suffering from incurable and/or debilitating diseases.

At Sonnenhof, children, together with their families, can spend the time they have left as they wish and find some relief from their suffering.

Instead of purchasing expensive gifts for the conference speakers, PDA has decided to donate this amount to the Sonnenhof Hospice. You can also contribute and help us in-crease the amount, it is easy: buy a package of chewing gums at the registration desk. THANK YOU!

To know more about the Sonnenhof Hospice, please visit www.bjoern-schulz-stiftung.de

SONNENHOF

SONNENHOF

SONNENHOF

Logo Sonnenhof - Farbwerte:Blau = C 100%/ M 30%/ Y 0%/ K 0%Gelb = C 0%/ M 25%/ Y 95%/ K 0%

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STERIS Deutschland GmbH Eupener Straße 70 50933 Cologne Germany T: +49 5136 97 06 12 2 F: +49 5136 97 06 12 1 andy_todd@steris.com www.STERISLifeSciences.com

STERIS Corporation is a leading provider of infection prevention and surgical products and services, focused primarily on critical health-care, pharmaceutical and research markets around the world. The Company supplies a broad array of equipment, consumable and service solutions that help assure productivity and quality. STERIS is listed on the New York Stock Exchange under the symbol STE. For more information, visit www.steris.com. STERIS has a comprehen-sive offering of detergents, disinfectants, skin care products and sterility assurance products that support your needs. We also have world class technical support to design the most effective cleaning program for your facility.

TERUMO Interleuvenlaan 40 3001 Leuven, Belgium Tel: +32 16 38 15 73 Fax: +32 16 381 604 info@terumo-gps.com www.terumo-gps.com

Founded in 1921 in Japan, Terumo is a global research & develop-ment company, offering a wide range of innovative products and services related to drug delivery devices, cardiology and cardiovas-cular systems, transfusion, patient monitoring and clinical systems. Terumo contributes to society by providing valued products and services in the healthcare market and by responding to the needs of healthcare providers and the people they serve. Unique technol-ogies and advanced devices are being offered to the pharmaceuti-cal industry in order to make medical treatment more comfortable, kinder and gentler.

Toxikon Europe NV Romeinsestraat 12 3001- Heverlee Belgium T: +32 16 400484 F: +32 16 401304 piet.christiaens@toxikon.be www.toxikon.be

Toxikon is a comprehensive testing organization, ISO-17025 accred-ited, providing a complete suite of services for the qualification and registration of medical devices, biomaterials and pharmaceuticals. Toxikon Europe is a subsidiary of Toxikon Corporation, a US based GLP-laboratory in Boston, covering the complete range of biocom-patibility and toxicology services. Toxikon Europe operates a state-of-the-art facility in Leuven, Belgium and specializes in the safety qualification of polymer materials (extractables studies, leachables studies). Other capabilities are lot release testing, microbiology and in-vitro toxicology procedures. All testing is performed according to the most recent guidelines, International and European Standards. Sponsor modified procedures, protocols, regulatory consultancy and analytical interpretation are available on request.

Veltek Associates Inc. 15 Lee Boulevard 19355 Malvern, PA United States Tel: +1 610 644 8335 Fax: +1 610 644 8334 vai@sterile.com www.sterile.com

Veltek Associates, Inc. is a single source supplier for all of your con-tamination control needs. VAI manufactures a broad line of sterile disinfectants, sporicides, cleaners and detergents in a variety of siz-es. In addition to multiple sizes, these products are available in sat-urated wipe packs. Veltek Associates, Inc.'s capabilities also include viable monitoring equipment. This product line consists of portable devices, compressed air / gas sampling and single unit multi loca-tion systems with an assortment of capabilities. Cleaning devices, laboratory services, cleanroom garments and consulting services are all part of the contamination control solutions VAI has to offer for every compliance challenge.

EXHIBITOR ABSTRACTS

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Watson-Marlow GmbH Mühlenweg 9 41569 - Rommerskirchen Germany P: +49 2183 42040F: +49 2183 82592info@wmftg.dewww.wmftg.de

Watson-Marlow Fluid Technology Group (WMFTG) is the world leader in niche peristaltic pumps and associated fluid path technologies for the food, pharmaceutical, chemical and environmental industries. Comprising nine established brands, each with their own area of ex-pertise, but together offering our customers unrivalled solutions for their pumping and fluid transfer applications. Customers demand many things from their process equipment and the prime concern is maintaining product integrity. Positive displacement pump compa-nies such as Watson-Marlow Fluid Technology Group (WMFTG) need to supply products which meet a range of requirements including: value for money; low cost of ownership; reliability; ease of main-tenance; and proven after sales service. We work closely with our customers to demonstrate how our positive displacement pumps ensure accurate metering, transfer and filling, can deliver significant process efficiencies over the lifetime of the equipment. WMFTG is a wholly owned subsidiary of Spirax-Sarco Engineering plc (LSE: SPX), a global organisation employing approximately 5,000 people world-wide. Watson-Marlow Fluid Technology Group comprises nine es-tablished brands, each with their own area of expertise, but together offering our customers unrivalled solutions for their pumping and fluid transfer applications

West Pharmaceutical Services Deutschland GmbH & Co.KG Stolberger Straße 21-41 52249 - Eschweiler Germany P: +49 2403 796 0 F: +49 2403 250 acsEurope@westpharma.com www.westpharma.com

West Pharmaceutical Services is a leading manufacturer of pack-aging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from con-cept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its cus-tomers from locations in North and South America, Europe, Asia and Australia

Wilco AG Rigackerstr. 11 5610 Wohlen Switzerland Tel: +41 56 618 43 43 Fax: +41 56 618 43 44 info@wilco.com www.wilco.com

WILCO AG provides in-line, off-line and laboratory machines with non-destructive testing methods for monitoring the oxygen content and container closure integrity simultaneously. Our patented leak detection methods based on the process analytical technologies (PAT) offers the opportunity for monitoring the finishing processes as well.We have newly implemented Visual Inspection technologies in our portfolio. With CCIT and Visual Inspection WILCO AG now cov-ers all inspection expectations for pharmaceutical products and our customers benefit from WILCO AG’s vast experience in quality inspection.

EXHIBITOR ABSTRACTS

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The Parenteral Drug Association presents...

PDA Education Program

30 June 2016Test Methods for Pre-filled Syringe Systems One-Day Training Course

30 June 2016Cleaning and Disinfection One-Day Training Course

30 June 2016How to Find the Right GMP for APIs One-Day Training Course

30 June - 01 July 2016Root Cause Investigation Two-Day Training Course

30 June - 01 July 2016Development and Manufacturing of Pre-filled Syringes Two-Day Workshop

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ONE-DAY TRAINING COURSE

Who Should Attend:

This course will be beneficial to individuals work-ing in Product Development, Quality Management, Regulatory Affairs and Manufacturing of syringe systems and related delivery devices

Learning Objectives:

Upon completion of this course, you will be able

• To understand the pros and cons of the different materials used for the Pre-filled Syringe

• To apply existing standards and monographs for specific syringe testing

• To explain the testing rationales used for test meth-ods at different stages

• To create a own testing plan according to your spe-cific application

Horst Koller, CEO, HK Packaging Consulting GmbH

Prior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 20 years industry experience. His consulting company is focussing on Technical, Regulatory and QM-Support around Primary and Sec-ondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active speaker on international conferences. He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim / Germany.

OverviewPre-filled Syringes (PFS) are used for different applications and throughout many therapeutic areas. They are available in glass and polymer, with and without needles already pre-attached to the syringes. Pre-filled Syringes fulfill two tasks: storage container and delivery device in one and the same system.The more components are used in such systems the more complex it will get, additionally if such Pre-filled Syringes are used in Auto-injectors or other delivery devices.

This one-day course will cover a short introduction into common materials used for the development and manufacturing of syringe systems. The main focus is on the test methods which are relevant for the different stag-es of a Pre-filled Syringe.

Test Methods for Pre-filled Systems

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TRAINING COURSE AGENDA

Thursday, 30 June 2016 9:00 – 17:00

9:00 Welcome

9:15 Introduction to Syringe Systems & Components• Polymer Syringes• Glass Syringes• Rubber Components and Closures

10:15 Luer Cone and Luer Lock Compliance Testing for Glass and Polymer Syringes

11:00 Coffee Break

11:30 Requirements for the Empty Sterile Sub-assembled Syringe Ready for Filling• Cone Breakage• Flange Breakage• Leakage

12:30 Lunch Break

13:30 Requirements for the Empty Sterile Sub-assembled Syringe Ready for Filling (continued)• Break-loose and Gliding Forces• Needle Penetration• Particulate Matter• Endotoxins

14:30 Requirements for Finished Pre-filled Syringes • Pharmacopoeia• FDA

15:30 Coffee Break

16:00 Additional Testing for Use in Delivery Devices• Auto-Injectors

17:00 End of Training Course

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ONE-DAY TRAINING COURSE

Peter Koger, MSc., Technical Sales Manager International, Veltek Associates Inc.

Peter Koger has been active in life science for over 35 years. First 12 years were spend in different laboratories in microbiology and the remainder working for various international organizations, active in the life science/pharmaceutical industry. For about 20 years Peter has been a technical resource to the pharmaceutical industry in relation to viable monitoring, cleaning & disinfection, and other aspects related to Aseptic Manufacturing and Contamination Control. Since 2002, he is a frequent industry speaker and since 2004, Peter has been a faculty member of PDA and other training institutes. Peter worked with several companies to help them get to best practice level

in Cleaning & Disinfection. Since 2005, Peter is working with Veltek Associates Inc., a leading manufacturer of sterile disinfectants, detergents, viable moni-toring equipment and several other innovative products focused on Contamination Control in the Pharmaceutical and Biotech industry. In his role, Peter is Technical Sales Manager responsible for Europe and part of Asia.

Cleaning and DisinfectionA practical approach

Who Should Attend:

• Production management• Operators responsible for/involved in C&D• Quality/Microbiology management• Quality personnel involved in C&D

Learning Objectives:

At the end of the workshop attendees should be able to develop or evaluate an existing cleaning and disinfection program in line with regulatory expectations and facility’s requirements for contamination control of classified areas.

Overview

This interactive course deals with all aspects of cleaning and disinfecting a sterile manufacturing facility. The information shared will encompass regulatory aspects, Environmental Monitoring, contamination sources, selection of disinfectants and cleaning agents, the validation and how they should be used properly.

Thursday, 30 June 2016 9:00 – 18:00

9:00 Welcome & Introduction

Subject Introduction | General Framework | Directives | Guidelines | Expectations

10:30 Coffee Break

Environmental Monitoring and Risk Analysis | Root Cause of Contamination

12:30 Lunch Break

13:30 Selection Criteria | Validation | Means and Methods

15:30 Coffee Break

Practical Approach | Supplies and Tools | Case Studies

18:00 End of Training Course

www.rommelag.com

rommelag agP.O. Box · CH-5033 Buchs, SwitzerlandPhone: +41 62 834 55 55 Fax: +41 62 8345500E-mail: mail@rommelag.ch

rommelag Kunststoff-MaschinenVertriebsgesellschaft mbHP.O. Box 1611 · D-71306 Waiblingen, GermanyPhone: +49 7151 95811-0 Fax: +49 7151 15526E-mail: mail@rommelag.de

rommelag USA, Inc.27905 Meadow Drive, Suite 9Evergreen CO 80439, USAPhone: +1.303. 674.8333Fax: +1.303.670.2666E-Mail: mail@rommelag.com

rommelag Trading (Shanghai) Co., Ltd.Room 104~107,1st Floor, No.510 Zhongshan South 2nd Road,Xuhui District, Shanghai, 200032 P.R. ChinaPhone: +86 21 5153 4967, +86 21 5153 4968Fax No.: +86 21 5153 4969E-mail: romcn@rommelag.com

Advanced aseptic packaging in one operation cycleReliable – Simple – Cost-Effective

bottelpack® Technology:• Integrated clean room US-class 100• Recognized by GMP, FDA, JP …• Aseptic packaging of liquids, creams, ointments …• Endless container designs in PE, PP…

Your benefits:• Tamper-proof packaging• Easy to open• Simple to use• Shatter-proof, no splinter hazard

adver_EN_210x297mm3in1_okt_2015.indd 1 05.10.15 17:00

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An ICH Q7 expert working group member instructs

ONE-DAY TRAINING COURSE

Who Should Attend:

This course is designed specifically for those in-volved or interested in the manufacturing of APIs, the suppliers to API manufacturers or CMOs of APIs. The targeted audience comes from:

• Quality• Production• Logistics • Engineering

Learning Objectives:

Upon completion of this course, the attendee will be able to:

• Avoid an over-interpretation of the GMP requirements in API manufacturing

• Know the keywords of the ICH Q7 guideline and how to interpret the guideline correctly

• Know the different responsibilities of quality and production

• Realize the additional GMP requirements for Bio-technology APIs

• Understand the meaning of ‘critical’ and its impact on quality processes

• Determine at which point in API manufacturing GMP needs to be applied

• Know how materials are re-used in a correct manner• Know what needs to be documented and which

departments are involved

Lothar Hartmann, Ph.D., Managing Director, IQP Consulting

Lothar Hartmann served at Hoffmann-La Roche in numerous functions nationally and globally. Lothar acted as Global Head of “Pharma-ceutical Quality Systems & External Relations”, interacting with regulatory health authorities and associations, and as “Global Head of Knowledge Management”. He also acted as Head of Quality at Crucell Berne, a Johnson & Johnson Group of Companies, before he built up his own company ‘IPQ Consulting’. Lothar Hartmann served for more than 10 years on the board of APIC/CEFIC as Vice-Chairman. In this function, he was nominated for the ICH Q7a Expert Working Group, writing the worldwide-harmonized GMPs for APIs. In this effort,

he also was FDA awarded in May 2004. He also founded and chaired the internationally recognized EBEs BioManufacturing Working Group for a number of years. Lothar is co- and lead-author of various documents published by CEFIC/APIC and EBE (European Biopharmaceutical Enterprises). He also served on the PDA Board of Directors, chaired the European Interest Group on Quality Systems and was co-founder of PDA’s “Paradigm Change in Manufacture” (PCMO) project which had the objective to address practical solutions for the day-to-day business of the new paradigm of ICH Q8 – Q11. Lothar Hartmann graduated from the Technical University of Berlin.

OverviewWhen API manufactures received their own GMP guideline by ICH, an important step was reached since there are significant differences between GMP requirements for Drug (Medicinal) Products and those for APIs.

This course will provide practical guidance of key aspects laid down in the ICH Q7 guideline. It will clarify and lay out the appropriate GMP standard to be applied by API manufacturers. In particular, it will address GMP related topics of quality, production, logistics, engineering and biotechnology.

PDA Europe is proud to offer participants this unique opportunity to receive first-hand knowledge, interpretation and understanding of ICH Q7, and to ask questions to one of the ICH Q7 authors.

How to Find the Right GMP for APIs:

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TRAINING COURSE AGENDA

Thursday, 30 June 2016 9:00 – 17:30

9:00 Welcome & Expectation Round of Participants

9:30 Regulatory Environment for APIs

10:00 Quality

10:30 Coffee Break

11:00 Workshop (Draw Flowchart for Handling Deviations / Investigations)

11:30 Discussion of Outcome of Workshops

12:00 Keywords of ICH Q7

12:30 Lunch Break

13:30 Documentation

14:00 Workshop (Key Items of Major SOPs)

14:30 Discussion of Outcome of Workshops

15:00 Coffee Break

15:30 General GMPs for Production, Logistic & Engineering

16:00 Re-use of Materials

16:30 Special Requirements for Biotechnology

17:00 Final Discussion Round

17:30 End of Training Course

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TWO-DAY TRAINING COURSE

Who Should Attend:

Alumni of this program typically (though not exclu-sively) have a background in:

• Quality• Risk management• Regulatory affairs• Compliance• Manufacturing• Product development• CAPA• Supply chain & purchasing• Production• Engineering• Project management• R&D• Fraud management• and more

Learning Objectives:

Upon completion of the workshop, participants will able to immediately, effectively, and efficiently apply the methodology to:

• Identify the technical root cause(s), that is, the change(s) that occurred.

• Identify systemic root cause(s), that is, any underlin-ing breakdown in the organizations broader systems that allowed the change(s) to occur.

• Implement a comprehensive corrective and/or pre-ventive action plan to restore performance.

• Implement a control plan to minimize and/or pre-vent recurrence.

Rob Weaver, President of Weaver Consulting

Founded in 2003, Weaver Consulting is a two-person enterprise comprised of Tom Weaver and Rob Weaver. They are quality and oper-ations improvement consultants who focus their business exclusively on root cause analysis. With a combined 40+ years’ experience and a client base that expands worldwide, they have helped organizations across a multitude of highly regulated industries, including pharmaceutical, medical device, aerospace, defense, financial services, food & beverage, consumer products, automotive, telecom-munications, semiconductors, and many more, successfully implement their premier root cause analysis methodology, Root Cause

Investigation for CAPA. Both Tom and Rob held titles of Vice President in their respective careers before joining the firm, Tom with Baxter Healthcare and Rob with Wells Fargo & Company.

OverviewRoot Cause Investigation for CAPA is an informative, practical, and engaging two-day workshop teaching a system-atic, science based, and proven methodology ideal for investigating any performance change. Examples: change in the performance of a product (tangible or intangible), machine or equipment, work process or system (physical or virtual), escalated customer complaints, etc. Based upon 40+ years’ experience, the methodology integrates problem solving techniques from Total Quality Management (TQM), Six Sigma, Kaizen, DMAIC (define, measure, analyze, improve, control), as well as other problem solving and process improvement techniques.

On day one, the participants are introduced to the seven step root cause investigation methodology. An Investi-gation Roadmap is provided to guide the participants through the steps and suggest appropriate tools. After each step is presented leveraging an instructor case study, the participants immediately apply the learning on their own case study (which is based upon a real life investigation). On day two, several hours are devoted to strength-ening the participants’ skills leveraging the methodology through practice on another, more complex, real life case study. As the participants work on this case study they will compare their work with that of the investigation conducted by the real team.

Participants will be emailed a set of electronic templates. These templates, plus the investigation roadmap, guide the investigator through the methodology and provide the basis for documentation.

Root Cause Investigation for CAPA

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TRAINING COURSE AGENDA

Thursday, 30 June 2016 9:00 – 18:00

9:00 Welcome & Introduction• Define technical CAPA problem• Common investigation mistakes• Investigation Roadmap template• Introduce 1st participant real life case study

10:00 Step 1: Define the Performance Problem• Introduce instructor case study• Problem statement• Problem description

10:30 Coffee Break

11:00 Step 1 Continued• Problem description continued• Workshop• Flow chart process(es) being investigated & identify key

inputs• Workshop• Time of events• Team charter including performance & cost savings goals

12:00 Lunch Break

13:00 Step 2: Collect Data• Determine data needed• Data collection tools & techniques• Data measurement plan• Workshop

15:00 Coffee Break

15:30 Step 3: Identify Possible Causes• Time of changes• Differences between Is & Is Not facts• Workshop• Changes associated with identified differences• Review risk analysis• Brainstorming techniques• Workshop

16:30 Step 4: Test Possible Causes• Test possible causes against facts• Summarize testing leveraging contradiction matrix• Historical perspective of investigations• Workshop

17:30 Step 5: Identify Technical & Systemic Root Causes• Verify assumptions• Conduct studies/experiments• Identify technical root cause(s)

18:00 End of Day 1

Friday, 1 July 2016 9:00 – 16:30

9:00 Step 5 Continued• dentify systemic root causes

9:30 Step 6: Determine Corrective/Preventive Actions• Mistake proofing techniques• Variation reduction & optimization techniques• Corrective/preventive actions• Acceptance criteria

10:30 Coffee Break

11:00 Step 6 Continued• Risk mitigation• Control plan• Workshop

11:45 Step 7: Verify Corrective/Preventive Actions• Implement & measure corrective/preventive actions• Evaluate control plan• Determine additional preventive actions

12:00 Lunch Break

13:00 Second Participant Real Life Case Study• Introduction• Workshop to develop problem statement, problem

description, identify possible causes• Workshop to collect data• Workshop to test possible causes

15:00 Coffee Break

15:30 Second Participant Real Life Case Study Continued• Workshop to determine corrective/preventive actions

including risk mitigation, control plan, acceptance criteria

13:00 Closing Remarks• Compare/contrast this investigation methodology

with traditional approach• Shortcuts• Simple investigations• Difficult investigations• Investigation report• Return on investment• References

16:30 End of Course

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Including hands-on exercises with equipment for processing,inspection and control

TWO-DAY WORKSHOP

Who Should Attend:

This course offers valuable insights and updates for anyone involved in development, production, quality, and purchasing of pre-filled syringes and relevant equipment

Learning Objectives:

You will learn how:

• Processes involved in primary packaging manufac-turing, filling and processing influence quality

• Relevant equipment can be used to achieve reproducible quality

Development and Manufacturing of Pre-filled Syringes

Overview

This two-day workshop will provide an overview of relevant practical aspects and trends of developing and processing pre-sterilized primary packaging systems. It will also focus on hot topics such as aseptic environments, particulates, silicone and single-use filling. In addition to theoretical insights, participants will have the opportunity to use equipment and perform testing by themselves in hands-on sessions. Processing steps, inspection and quality aspects will be demonstrated using state-of-the-art technology.

Moderator: Christa Jansen-Otten, Director Marketing PFS Europa, West Pharmaceutical Systems Horst Koller, CEO, HK-Packaging Consulting

Speaker: Simone Biel, Field Marketing Specialist, Merck Millipore Maurizio Trombetta, Sales Manager, Metall + Plastic Oliver Valet, Managing Director, rap.ID Josef Veile, Director Engineering and Design, Groninger Patrizia Wenzel, Sales Manager, Biesterfeld Spezialchemie

Faculty

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WORKSHOP AGENDA

Thursday, 30 June 2016 9:00 – 17:45

9:00 Welcome and Introduction Christa Jansen-Otten, West

9:15 Market Overview and Trends in Primary Packaging:• Global & Regional Pharmaceutical Market / Injectable Market /

Challenges / Changes in Manufacturing / Devices

Christa Jansen-Otten, West

9:45 The Complete Process to Manufacture Pre-filled Syringes - From Washing to Packaging, Part I: • Material / Forming / Cleaning / Siliconization / Pre-Assembly / Sterilization

Josef Veile, Groninger

10:45 Coffee Break

11:15 The Complete Process to Manufacture Pre-filled Syringes - From Washing to Packaging, Part II: • Unpacking / Filling / Control & Close / Labelling / Packaging

Josef Veile, Groninger

11:45 Single-Use in Final Filling:• Process Design • Quality Considerations

Simone Biel, Merck Millipore

12:30 Lunch Break

13:30 Silicone: “The Chemistry Behind It” / Chemical and Physical Aspects Patrizia Wenzel, Biesterfeld Spezialchemie

14:00 Control of Silicone Layer and Particulate Matter:• Technology / Lubrication control / Investigation strategy / Distribution

and stability measurement / Relationship between silicone oil distribution and protein aggregation / Good Particles Investigation Practice / Visual classification / Documentation / Microscopy / Raman, LIBS, IR/ATR- Spectroscopy

Oliver Valet, rap.ID

14:45 Coffee Break

15:15 Hands-On Training using Industry Equipment:• Silicone distribution (rap.ID)• Siliconization (Groninger)• Silicone chemical/physical aspects (Biesterfeld)• Single Use (Merck Millipore)• Filling (Groninger)

Practical Training provided by various suppliers

17:15 Q & A, Open Discussion All

17:45 End of Day 1

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Friday, 1 July 2016 8:30 – 16:45

8:30 A Comparison of Pre-filled Syringes Filling Operations in RABS and Isolators

Maurizio Trombetta, Metall + Plastic

9:15 Material, Manufacturing, Process and Quality Effects on Glass:• Polymers / Coating / Multilayer

Horst Koller, HK Packaging

10:00 Coffee Break

10:30 Elastomeric Closures for Pre-filled Syringe and Cartridge Applications: • Manufacturing / Requirements / Coatings / Quality / Extractable /

Regulatory / Adopted Packaging

Christa Jansen-Otten, West

11:30 Comparing Different Solutions on Nested Containers• BD / Gerresheimer / NIPRO / OMPI / Schott / West

Horst Koller, HK Packaging

12:00 Q&A on Nested Packaging Horst Koller, HK Packaging

12:15 Development and Regulatory Aspects of Primary Packaging Material: Transfer from Vial into Syringe

Horst Koller, HK Packaging

13:15 Lunch Break

14:15 Hands-On:• Stoppering (Groninger)• Particle Identification (rap.ID)• Primary Packaging (West)• Packaging and Components (HK Packaging)

Practical Training provided by various suppliers

16:15 Q & A, Open Discussion All

16:45 End of Training Course

WORKSHOP AGENDA

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INFORMATION

V E N U EEstrel BerlinSonnenallee 22512057 BerlinGermanyTel.: + 49 (0) 30 683 10

CO NTAC T I N FO R M ATI O NConference InquiriesMelanie DeckerDirector Events & Exhibitionsdecker@pda.org

Conference Program InquiriesSylvia BeckerManager Programs & Eventsbecker@pda.org

Registration & Customer CareTel: + 49 30 4365508-10registration-europe@pda.org

Education Program InquiriesElke von LaufenbergManager Training & Educationlaufenberg@pda.org

Exhibition/Sponsorship Inquiries Creixell Espilla-GilartManager Exhibition & Sponsorship espilla@pda.org

O RG A N I Z E RPDA Europe gGmbHAm Borsigturm 6013507 Berlin, GermanyTel: + 49 30 4365508-0Fax: + 49 30 4365508-66info-europe@pda.org

E X PLO R E B E R LI N!PDA Europe is proud to offer you additional opportunities to explore Berlin whilst you are here! Don't miss experiencing some of the cultural variety Berlin has to offer. Partnering with PDA Europe, Art Berlin, a renowned tourism agency, has put together some activities for you to choose from.Make your stay in Berlin even more memorable and unique!

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Hints for Using Social Media We would like to encourage you in using Social Media Portals and to fuel the dialogue about

PDA Europe and the ‘‘1st PDA Europe Annual Meeting’’

PDA Europe is active on Twitter @PDA_Europe and LinkedIn PDA-Parenteral Drug Association Group.

For this meeting we are using the hashtag #pdaeuannual to upload all content related to

this conference on these platforms.

By joining LinkedIn and Twitter and using them to promote your participation in all of our

events, you can actively help increase the number of participants to any given event while

also drawing attention to your own company and to your personal profiles. Thus, together we

will maximize your exposure to the leaders and key decision makers of the pharmaceutical

and biopharmaceutical industry!

The PDA - Parenteral Drug Association Group and 1st PDA Europe Annual Meeting Group are open to everyone on LinkedIn. Please join these groups and become part of interesting discussions, raise

questions, show your involvement, interact with your peers and be present!

Example Content: “Looking for a cost-reduction on your primary packaging? We will be at the #pdaeuannual conference – visit us at table-top Nr. XXXX and get the chance to win an ipad/prize/whatever you want to give/ together with the best instrument for your new drug launch!’’ You can post a link to your own website, video on you tube, PDF brochure…

Before, during, and after the “1st PDA Europe Annual Meeting” the hashtag #pdaeuannual will be used to mark and identify event related tweets. This is perfect to let everybody know about your

involvement!

By using the hashtag #pdaeuannual, you further ensure that all tweets are collected under this topic, therefore creating a permanent history of all related tweets.

Example Tweet: “Our company will be exhibiting at the 1st PDA Europe Annual Meeting #pdaeuannual this year! Visit our booth in Hall C! @PDA_Europe”

Or “See our newest product at the 1st PDA Europe Annual Meeting #pdaeuannual @PDA_Europe” – you can add a link, a video or even a pdf presenting your product! There are many way of using this channel, feel free to post pictures, videos and the like.

You can also create a hashtag and / or account of your own company to link your posts.

SOCIAL MEDIA

Save the Date

13-14 June 2017

PDA Europe 2nd Annual Meeting