1 st PDA Europe Annual Meeting The Parenteral Drug Association presents: THE FUTURE IN INJECTABLES 2016 30 June - 1 July Root Cause Investigation 30 June - 1 July Development of Pre-Filled Syringes 30 June Test Methods for Pre-Filled Syringes 30 June Cleaning and Disinfection 30 June How to Find the Right GMP for APIs europe.pda.org/AnnualMeeting2016 28-29 June 2016 Estrel Hotel Berlin Berlin | Germany Gold Sponsor Platinum Sponsor Silver Sponsor Media Partner
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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
30 June - 1 July Root Cause Investigation
30 June - 1 July Development of Pre-Filled Syringes
30 June Test Methods for Pre-Filled Syringes
30 June Cleaning and Disinfection
30 June How to Find the Right GMP for APIs
europe.pda.org/AnnualMeeting2016
28-29 June 2016 Estrel Hotel Berlin
Berlin | Germany
Gold SponsorPlatinum Sponsor Silver Sponsor Media Partner
2 europe.pda.org/AnnualMeeting2016
LETTER FROM THE CHAIR
Dear Friends, Colleagues, Collaborators and Peers,We are all witnessing a paradigm shift in scientific, technical and regulatory approaches to healthcare. Innovative technologies raise the quality and safety of our manufacturing and distribution processes and offer increased efficiencies and flexibilities. Regulatory oversight is becoming increasingly risk based and strives for convergence on a global scale. Our industry is evolving towards an increasingly agile and flexible manufacturing mode that can accommodate shifting demands, deliver innovative therapies, and master current and future healthcare challenges. 21st century manufacturing will be light years away from the traditional approaches we were accustomed to.
On 28-29 June 2016, PDA Europe’s first Annual Meeting The Future in Injectables will provide you with a first-hand opportunity to stay current and apprehend future advances in modern sterile manufacturing and quality oversight. We will 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 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.
Mark your calendars now and plan to join us in Berlin/Germany from June 28th to July 1st, 2016.
On behalf of the program planning committee and PDA staff, I look forward to welcoming you there!
Ursula Busse, PhD MBA, Novartis Group Quality Conference Chairwoman
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!
ITALY / SWITZERLAND (TESSIN)
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 )
8:00 • Scope and Activities• Technical Report #65• TT IG current picture
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- Pretreatment Water System
Kavita Ramalingam lyer, Merck Sharp & Dohme Corp.
Annex 2 and a Case Study Enabling Risk-Based Biopharmaceutical Facility Design Approaches
Paul Lopolito, STERIS Corporation
A Scientific Approach to Maintain your Stainless Steel Surfaces
POSTER SESSION
This Poster Session is still open for your proposal. Please submit directly to Sylvia Becker at [email protected]
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
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 Syringes.
Peter Koger, Technical Sales Manager International, Veltek Associates Inc.
Peter Koger MSc. 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 Manufacture 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 monitoring 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.
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
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 “Board of Directors” of PDA, 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.
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.
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
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 SU, Merck Millipore Josef Veile, Technical Director, Groninger Patrizia Wenzel, Sales Manager, Biesterfeld Spezialchemie
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 SyringesFrom Washing to Packaging, Part I:• Machine and Equipment / Bulk and Ready to Use Concepts /
IPC / RABS and Isolators
Josef Veile, Groninger
10:45 Coffee Break
11:15 The Complete Process to Manufacture Pre-filled SyringesFrom Washing to Packaging, Part II:• Machine and Equipment / Bulk and Ready to Use Concepts /
IPC / RABS and Isolators
Josef Veile, Groninger
11:45 Silicone: “The Chemistry Behind It” / Chemical and Physical Aspects Patrizia Wenzel, Biesterfeld Spezialchemie
12:15 Lunch Break
13:15 Single-Use in Final Filling:• Process Design • Quality Considerations
Simone Biel, Merck Mllipore
14:00 A Comparision of Pre-filled Syringes Filling Operations in RABS and Isolators
M+P speaker
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)
G E N E R A L A D D R E S SPDA Europe gGmbHAm Borsigturm 6013507 Berlin, GermanyTel: + 49 30 4365508-0Fax: + 49 30 [email protected]
CO N F E R E N C E R EG I S TR ATI O N H O U R SMonday, 27 June: 9:00 – 18:00Tuesday, 28 June: 8:00 – 18:00Wednesday, 29 June: 7:00 – 17:00
CO U R S E R EG I S TR ATI O N H O U R SThursday, 30 June: 8:00 – 16:30Friday, 01 July: 8:30 – 12:00
TO E X H I B ITExhibition and Sponsorship Opportunities are available. PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of high-ly-qualified, upper-level professionals in the pharmaceuti-cal and biopharmaceutical industry. Exhibit at PDA events and let your company’s products or services become a valuable tool or resource for our attendees. Please see the Exhibition Floor Planorg go to: europe.pda.org/AnnualMeeting2016
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Special offer: Discounted travel with Lufthansa Group Airlines
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PDA Europe Conference, Exhibition, Workshops, Training Courses
1st PDA Europe Annual Meeting28 June - 01 July | Berlin | Germany
Your registration is only complete upon filling in and submitting both pages of this form.
1 RegistrationNo PDA membership included
Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 1295 Euro per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount).
*Discount for Exhibiting Companies
30 June One-Day Training Course Training Course Fee netto
Test Methods for Pre-filled Syringe Systems All Participants 695
30 June One-Day Training Course Training Course Fee netto
How to Find the Right GMP for APIs All Participants 695
30 June One-Day Training Course Training Course Fee netto
Cleaning and Disinfection All Participants 695
30 June - 01 July Two-Day Training Course Training Course Fee netto
Root Cause Investigation All Participants 1395
30 June - 01 July Two-Day Workshop Workshop Fee netto
Development and Manufacturing of Pre-filled Syringes
All Participants 1495
Group Registration Discount Register 5 colleagues for the conference at the same time and receive the 5th registration free. For more information on group discounts please contact us at [email protected]. Other discounts cannot be applied.
The fee includes course documentation as well as mid-session refreshments and lunch. Excellent networking opportunities with snacks and drinks will be given. The fee does not include the hotel accommodation. PDA Europe has secured a limited number of rooms at a special group rate.
Book by 25 March 2016 and save! EARLY BIRD DISCOUNT
28-29 June Conference only Conference Fee By 25 March 2016 After 25 March 2016
1st PDA Europe Annual Meeting PDA Member 995 1595Nonmember 1645 1895
Regulatory / Academic 700 800Discount for Exhibiting Companies (see below)*
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PDA Europe Conference, Exhibition, Workshops, Training Courses
1st PDA Europe Annual Meeting28 June - 01 July | Berlin | Germany
Training Course InformationElke von LaufenbergManager Training & EducationTel: + 49 30 [email protected]
LegendIG – Interest Group MeetingTC – Training CourseWS – Workshop
2 0 1 6 P D A E U R O P E A C T I V I T I E S & E V E N T S 31 May - 1 June
Current Challenges in Aseptic Processing, Potential Changes in EMA/PIC/S Annex 1 Revision
WS Berlin, Germany
6 June7-8 June9 June9 June
Viral Safety of ATMPs | Conference Advanced Therapy Medicinal Products | ConferencePractical Application of GMP for Development of ATMPsVirus Filtration
TCTC
Berlin, Germany
28-29 June30 June30 June30 June30 June - 1 July30 June - 1 July
1st PDA Europe Annual MeetingTest Methods for Pre-filled Syringe SystemsCleaning and Disinfection How to Find the Right GMP for APIsRoot Cause Investigation Development and Manufacturing of Pre-filled Syringes
TCTCTCTCWS
Berlin, Germany
20-21 September22 September22 September22-23 September22-23 September22-23 September22-23 September
9th Workshop on Monoclonal AntibodiesElastomersRecombinant Proteins: From Gene to Product CMC Regulatory Compliance for BiopharmaceuticalsExtractables and LeachablesIntroduction to Aseptic Processing PrinciplesStatistics of Production Monitoring and Capability
TCTCTCTCTC
Rome, Italy
27-28 September29 September29-30 September
Pharmaceutical Freeze Drying Technology | ConferenceApplication of a Risk-Based Approach to Freeze-Drying ProcessesDevelopment of a Freeze Drying Process
TCWS
Strasbourg, France
5-6 OctoberCurrent Challenges in Aseptic Processing, Potential Changes in EMA/PIC/S Annex 1 Revision
Particle Identification in Parenterals Visual Inspection ForumAn Introduction to Visual Inspection: A Hands-on Course
TC
TCBerlin, Germany
8-9 November Data Integrity WS Berlin, Germany
14 November15-16 November17 November17-18 November
Risk-based Approach for Prevention and Management of Drug ShortagesOutsourcing & Contract Manufacturing | ConferenceQuality by Design for BiopharmaceuticalsRoot Cause Investigation
TC
TCTC
Barcelona, Spain
Subject to change For latest info: europe.pda.org Shortlist 27 May 2016