The Parenteral Drug Association presents:
2nd PDA Europe Annual Meeting Global Healthcare of the Present & the Future
13-14 June 2017 Hilton Berlin Berlin | Germany
LETTER FROM THE CO-CHAIRS Dear Colleagues, SCIENTIFIC PROGR AM PL ANNING COMMIT TEE
Stephan Rönninger, Amgen, Chair Véronique Davoust, Pfizer, Co-Chair Ivo Backx, Siemens Borke van Belle, Janssen J&J Mario Bott, Fraunhofer IPA Tor Gråberg, AstraZeneca Maik Jornitz, G-CON Manufacturing Toni Manzano, BigFinite Yves Mayeresse, GlaxoSmithKline Mike Morris, Ext. HPRA Chris Procyshyn, Vanrx Pharmasystems Ryan Smith, Sight Machine Falk Klar, PDA Europe Georg Roessling, PDA Europe
On behalf of the scientific program planning committee, we would like to invite you to the 2nd PDA Europe Annual Meeting held in Berlin / Germany, 13-14 June 2017. The topic of this Annual Meeting is Global Healthcare of the Present & the Future, spanning a bridge between current demands in the global healthcare industry, big data issues as well as promising personalized medicine and medicinal products. The meeting will also include presentations from regulatory, industry and technology representatives from around the world. A comprehensive exhibition including a Poster Session to catch up on the latest developments will give you the opportunity to network and interact with speakers and fellow attendees. As customary for PDA, the event will be accompanied by an excellent Education Program, with a Workshop on Annex 1 and a training on Aseptic Processing Principles - just to name some of the highlights. Check the schedule on the next page for a detailed overview of all events. We look forward to meeting you in Berlin!
Stephan Rönninger, Amgen, Conference Chair
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Véronique Davoust, Pfizer, Conference Co-Chair
S C H E D U L E AT A G L A N C E 12 June
9:00 – 18:00
Quality by Design (QbD) for Biopharmaceuticals
Training Course
12 June
10:00 – 17:00
Revision of Annex 1
Pre-Conference Workshop
12 June
13:00 – 17:00
Business Opportunities Iran
Pre-Conference Workshop
12 June
9:00 – 18:00
Cleaning and Disinfection
Training Course
13 June
9:00 – 18:30
2nd PDA Europe Annual Meeting
Conference, Exhibition
13 June
19:00 – 22:30 Networking Event at “Pier 13”
14 June
8:30 – 16:00
2nd PDA Europe Annual Meeting
Conference, Exhibition
15 June 16 June
9:00 – 18:00 9:00 – 17:00
Introduction to Aseptic Processing Principles
Training Course
15 June 16 June
9:00 – 17:45 9:00 – 16:30
Practical Approach to Quality Culture
Training Course
For latest information, please visit: pda.org/eu-AnnualMeeting2017
pda.org/eu-AnnualMeeting2017
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PRE CONFERENCE AGENDA
Revision of Annex 1 Monday, 12 June 2017 10:00
Welcome
10:00 – 17:00 Falk Klar, PDA Europe Gabriele Gori, GlaxoSmithKline Vaccines
Opening: Regulatory Update: Revision of Annex 1 10:10
Regulatory Perspectives on Inspectional Findings and the Revision of the EU GMP Annex 1
Andrew Hopkins, MHRA
10:40
Inspector’s Perspective: Needs for Annex 1 Revision
Beate Reutter, Landesamt für Soziale Dienste
11:10
Q&A, Urgent Questions for Regulators
11:20
Coffee Break & Exhibition
Session 1: Quality Risk Management for Aseptic Processing
Moderator: Vincent O’Shaughnessy, Amgen
11:50
QRM and the Aseptic Processing Control Strategy
Kelly Waldron, Val Source
12:10
Risk Based Process Design for a Sterile Suspension
Geert Vandenbossche, Novartis
12:30
Roundtable Discussion: Identifying Key Questions for Regulators
12:50
Panel Discussion with Regulators
13:10
Lunch Break & Exhibition
Session 2: Contamination Control: From Cleanroom to Isolator
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Moderator: Gabriele Gori, GlaxoSmithKline Vaccines
14:10
Advanced Aseptic Manufacturing with Barrier Systems Annex 1’s Impact in the Fill / Finish Process Environment
14:30
Roundtable Discussion: Identifying Key Questions for Regulators
14:50
Panel Discussion with Regulators
15:10
Coffee Break & Exhibition
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Moderator: Gabriele Gori, GlaxoSmithKline Vaccines Johannes Rauschnabel, Robert Bosch GmbH
PRE CONFERENCE AGENDA
Session 3: Contamination Control: Container Closure Systems
Moderator: Geert Vandenbossche, Novartis
15:40
Meaningful Control Strategy for Container Closure Integrity
16:00
Roundtable Discussion: Identifying Key Questions for Regulators
16:20
Panel Discussion with Regulators
16:40
Summary Remarks
Derek Duncan, LIGHTHOUSE
Falk Klar, PDA Europe Gabriele Gori, GlaxoSmithKline Vaccines
17:00
End of Workshop
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PRE CONFERENCE AGENDA
Business Opportunities Iran Following the success of the first PDA Conference in Teheran (Iran) in September 2016, PDA Europe is organizing the workshop “Business Opportunites In Iran” previously to the 2nd PDA Europe Annual Meeting. This workshop has been specially designed for companies interested in establishing business contacts in Iran and sharing information to further develop successful collaborations. The workshop will feature several speakers from different companies and institutions and will foster personal exchange within its participants.
Monday, 12 June 2017 Welcome & Introductions Pharmaceutical Landscape in Iran
Farzad Peiravian, IFDA invited Georg Roessling, PDA Europe Moderator: Georg Roessling, PDA Europe
Regulatory Perspective & Regulatory Framework
Farzad Peiravian, IFDA invited
Doing Pharma Business in Iran Experiences of a European Company
Saad Moimini, Novo Nordisk
The Iranian Pharma Industry Opportunities in Post-Sanctions Era
Alireza Zahraee
Update on PICs
Zohre Bazaz, IFDA
Technology Trends
Moderator: Georg Roessling, PDA Europe
Modern Concepts of Primary Packaging - Ready to fill Concept
Lorenza Bonaldi, OMPI
Visible Particulate Matter Control Strategy – USP <1790>
Oliver Valet, rap.ID
Benefits of Modularity and Rapid Bio-Decontamination for Processing in Small Scale Aseptic Filling Line
Paolo Liverani, Getinge
Product Portfolio and Trends
Christa Janssen-Otto, West
Q&A, Discussion with Exhibitors and Conference Participants 15:45
Coffee Break & Exhibition Equipment and Manufacturing Machines Solutions with Multi-Use Filling Lines
Basem Gerges, Optima
Non-destructive, Deterministic Inspection Technologies for CCIT on Ampoules, IV Bags and the Trends for Vials and Syringes
Jaime Cobo, Wilco
Title to be confirmed
Michael McGowan, SHL
Q&A and Panel Discussion with Exhibitors and Conference Participants 18:00 6
Moderator: Georg Roessling, PDA Europe
End of Workshop
pda.org/eu-AnnualMeeting2017
The Parenteral Drug Association presents:
2017 PDA Europe Conference, Exhibition
Outsourcing & Contract Manufacturing
Register by 24 Sep 2017 and SAVE!
pda.org/EU-Outsourcing2017
21-22 November 2017 Roomers Design Hotel Munich | Germany
CONFERENCE AGENDA
Tuesday, 13 June 2017 9:00
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Welcome & Introductions Opening Remarks & PDA Interactive: Quo Vadis, Pharma Industry?
Falk Klar, PDA Europe
Keynote 9:30
Current Political Landscape and the Future of Our Industry
Martin Lush, NSF Health Sciences
Opening Plenary
CURRENT DEMANDS
10:00
International Regulations of Pharmaceuticals in the Future
Emer Cooke, WHO
10:30
GMP Harmonisation - Challenges and Opportunities
Paul Hargreaves, MHRA / PIC/S
11:00
Medical Products & Regulatory System in Iran
Rassoul Dinarvand, IFDA
11:30
Coffee Break, Poster Session & Exhibition
12:00
Challenges in Vaccines Development and Manufacturing
12:30
Q&A, Discussion
13:00
Lunch Break, Poster Session & Exhibition
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Stephan Roenninger, Amgen Véronique Davoust, Pfizer Anja Ebers, Meeting Facilitator
Moderator: Stephan Roenninger, Amgen
Rahul Singhvie, Takeda
CONFERENCE AGENDA
PAR ALLEL TR ACKS Session 1
TRACK A
TRACK B
TRENDS IN MODERN ENGINEERING
HUMAN FACTORS
Engineering has always been an applied science, improving technology to deliver cost effective and optimal solutions. New factories and old are built and retrofitted to become more flexible in all of the operations involved. Different tools are available and can be activated to achieve this goal: new operational models, single-use systems, continuous processing and modular approaches. A comparison of different cleanroom designs with the associated benefits and drawbacks will be presented in this session. The world becomes increasingly digital, and also in manufacturing, all the processes along the lifecycle need to become more interconnected. Digital simulation and modelling of any future project helps evaluate the potential for improvement. Feasibility studies, through commissioning, plant management and even maintenance and service need to be made interdependent. Integration allows not only an increase in efficiency, but also a reduction in cost and improvement in overall process and product quality. All these topics will be discussed in detail during this session.
The human factor in relation to pharmaceutical products deserves an end-to-end focus. Providing solutions for patients and healthcare workers requires full understanding of the user-to-product interface, the patient’s condition and application conditions. This information and insight needs to be built into the product during Research and Development. On the other hand, Good Manufacturing Practices and regulatory expectations applying to supply and distribution chains safeguard the companies and patients through a number of preventive requirements and corrective controls to manage potential impact of the human factor. In this session, we will focus on this end-to-end view, and learn how the patient as ultimate customer is centric in understanding the human factor as being key for the success of a pharmaceutical product.
Moderator: Yves Mayeresse, GSK
Moderator: Borke Van Belle, Janssen J&J
Comparison of Cleanroom Designs & Structures Cost and Benefit Review
User Centered Design: Exploring Physical Capabilities of Intended Users
Maik Jornitz, G-CON Manufacturing
Nicholas Stones, Novartis
Flexibility by Design – Flexibility and Innovation in Facility Design for Manufacturing of Tomorrow’s Vital Biopharmaceutical Products
The Patient Perspective
Alex Severin, NNE
Jez Clements, Cambridge Design Partnership
From Integrated Engineering to Integrated Operation
How Mixed Reality Will Drive the Future of Drug Delivery Product Development
Fabio Paganelli, Siemens
Serge Dubeau & Matt Gottschalk, Worrell
15:30
Q&A, Discussion
Q&A, Discussion
16:00
Coffee Break, Poster Session & Exhibition
14:00
14:30
15:00
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CONFERENCE AGENDA
PAR ALLEL TR ACKS Session 2
TRACK A
TRACK B
SECURING THE SUPPLY CHAIN
MANAGING THE QUALITY-COST DILEMMA
Quality requirements in the supply chain are increasing in an effort to prevent counterfeits and drug shortages. This session will focus on and provide an insight on how risk of drug shortages can be addressed and what manufacturers can do. A tool for managing single and multi-source challenges for drug availability will provide a practical example on how manufacturers and/or Marketing Authorization holders but also wholesalers can manage continued supply. Finally, we will receive an overview on current expectations on the distribution of medicines, highlighting pitfalls from an inspector’s point of view.
Is there any contradiction between quality and cost? Or is it simply the way that lack of quality will immediately increase the cost? This potential dilemma will be scrutinized in conjunction with the importance of Quality Culture both from an industry perspective as well as the view of regulators. Attendees will gain an understanding of the importance to facilitate quality in combination with cost awareness as well as the paramount need for a clear Quality Culture.
Moderator: Stephan Roenninger, Amgen
Moderator: Tor Gråberg, AstraZeneca
Managing Single- and Multi-Source Supply Chain Challenges: A Practical Tool
Total Cost of Quality: Speaking Business Language
Emma Ramnarine, Genentech / Roche
Borke van Belle, Janssen J&J
Reducing Risk of Drug Products Shortages
Developing a Culture of Quality
Yvonne Stewart, GSK
Frederik Åsell, AstraZeneca
Experience with GDP Inspections
Are Quality Costs Fully Calculable? A GMP-Inspector’s View
Terence Madigan, MHRA
Rainer Gnibl, District Government of Upper Bavaria
18:00
Q&A, Discussion
Q&A, Discussion
18:30
End of Day 1 & Networking Event at Pier13
16:30
17:00
17:30
2017 PDA Europe Annual Meeting Speakers https://goo.gl/P8bVvI
Summer in Berlin nd a B PDA g Live! in Play anged by H ea d
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PLEASE JOIN US FOR OUR NETWORKING EVENT AT “PIER 13”, TUESDAY, 13 JUNE 2017 Meeting Point: Hilton Berlin Hotel Lobby 19:00 - Shuttle Bus leaving 19:30 - Dinner & Party 22:30 - Shuttle Bus returning to the Hotel
CONFERENCE AGENDA
Wednesday, 14 June 2017 7:30
PDA Orientation Breakfast
8:30
Welcome Coffee, Poster Session & Exhibition
PAR ALLEL TR ACKS Session 3
TRACK A
TRACK B
ADVANCED ASEPTIC PROCESSING & ENVIRONMENTAL MONITORING
CONNECTIVITY, SMART DEVICES & ANALYTICS
With the increased focus on advanced processes, the limits of traditional environmental monitoring methods are being stretched. Experts from a range of companies will provide insight into their experiences with new monitoring technologies, as well as the practical implementation of these technologies into new automated, closed aseptic processes. Attendees will gain an understanding of the regulatory implications and a view to the future.
Do we know the real implication of the digital transformation in the industry? Industrial Internet of Things or Machine to Machine are terms that begin to sound familiar in pharma and that are a reality in the health, automotive and energy sectors. When the cloud concept is added to these ingredients, new concerns arise. The industrial digitalization obviously requires innovative technology, but also a new mindset able to advance people into a new generation driven by connectivity: the era where existing knowledge becomes part of production.
Moderator: Christopher Procyshyn, Vanrx
Moderator: Toni Manzano, Bigfinite
Continuous Microbiological Monitoring for Aseptic Manufacturing
Driving Digital Transformation: Best Practices for Realizing Value from New Technology within your Organization
Jeffrey Weber, Pfizer
Ryan Smith, Sight Machine
New Advanced Aseptic Filling Technology in a New Greenfield Manufacturing Facility
Digital Transformation Systems in Healthcare
Aidan Harrington, DPS Engineering
Saso Jezernik, Altran
Repeatable H₂O₂ Measurement during Bio-Decontamination: Measurement Tech nology, Relative Humidity vs. Relative Saturation and Material Selections
Internet of Things for Predictive Analytics
Irene Zakrzewski, Vaisala
Wim De Bruyn, Ghent University
10:30
Q&A, Discussion
Q&A, Discussion
11:00
Coffee Break, Poster Session & Exhibition
9:00
9:30
10:00
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CONFERENCE AGENDA
PAR ALLEL TR ACKS Session 4
11:30
12:00
12:30
TRACK A
TRACK B
FACILITY DESIGN & MODELLING
CONNECTIVITY, HANDLING BIG DATA & DATA MANAGEMENT
Moderator: Mike Morris, exHPRA
Moderator: Ryan Smith, Sight Machine
Organising the Interface between GMP and GCP for Production and Clinical Application of Advanced Cell and Gene Therapeutics
Big Data, Internet of Things, Machine Learning, Artificial Intelligence: How to Transform Pharma Manufacturing & Biotech Processes
Lutz Uharek, Charité Berlin
Thomas Unger, Bigfinite
Process Design – Migration to a Modelling Based Workflow
From Bits to Bedside: Developing a Learning Digital Health System to Evaluate Pigmented Skin Lesions
Mateusz Landowski, DPS Engineering
Dexter Hadley, University of California, San Francisco
Risk-based Tools for Designating Appropriate Room Classification for Biopharmaceutical Operations in Conceptual Design
Discovering Novel Biomarkers by Robotic Molecular Diagnosis
Lars Hovmand-Lyster, Novo Nordisk
Nathan Boley, DRIVER
13:00
Lunch Break, Poster Session & Exhibition
Closing Plenary
TECHNOLOGIES & PHARMA OF THE FUTURE
14:00
Light and Life: How Spectroscopy Supports the Life Sciences
Jürgen Popp, Leibniz Institute of Photonic Technology
14:30
Reimbursement and Cost of Quality
Richard Brand, BeyondSpring Pharma
15:00
Panel Discussion
Richard Brand, BeyondSpring Pharma
Quo Vadis, Pharma Industry?
Paul Hargreaves, MHRA
• Global Disease Management and Medicines, Challenges,
Moderator: Véronique Davoust, Pfizer
Demands & Future Opportunities • Insurance & Coverage, Novel Technologies, Funding & Availability • Paradigm Shifts: Interconnect R&D, Industry, Patient & Payers
Richard Johnson, PDA Martin Lush, NSF Health Sciences Yves Mayeresse, GlaxoSmithKline Christopher Procyshyn, Vanrx Lutz Uharek, Charité Berlin
16:00
Closing Remarks End of Conference & Farewell
Falk Klar, PDA Europe Stephan Roenninger, Amgen Véronique Davoust, Pfizer pda.org/eu-AnnualMeeting2017
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EXHIBITION
CURRENT DEMANDS, UNDERSTANDING MANUFACTURING & MODERN ENGINEERING, SECURING THE SUPPLY CHAIN, USING MODELLING TO ENHANCE UNDERSTANDING, HUMAN FACTORS, CONNECTIVITY, HANDLING BIG DATA & DATA MANAGEMENT, MANAGING THE QUALITY-COST DILEMMA, MEDICINAL PRODUCTS
2 DAYS CONFERENCE MORE THAN 300 ATTENDEES
TRAININGS: CLEANING & DISINFECTION/ SUPPLY CHAIN STRATEGIES FOR API AND DRUG PRODUCT/ QUALITY BY DESIGN FOR BIOPHARMACEUTICALS/ INTRODUCTION TO ASEPTIC PROCESSING PRINCIPLES/ QUALITY CULTURE
EXHIBITION WITH SOLUTION PROVIDERS FROM AROUND THE GLOBE
AUTHENTIC NETWORKING OPPORTUNITIES IN THE HEART OF BERLIN
TO E X H I B IT: PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highly-qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibition and Sponsorship Opportunities are available. A basic exhibition package for this event is priced 2.495 Euro net (table-top). For more information please contact expo-europe@pda.org 14
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FLOOR PLAN - HILTON HOTEL BERLIN
35 34 PDA Lounge
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ENTRANCE
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Training & Education Program europe.pda.org
PDA
Education offers courses that are developed and taught by experts. They are uniquely targeted to professionals involved in the development and manufacturing of quality pharmaceutical and biopharmaceutical products.
Facts that Make a Difference Up-to date training courses and workshops taught by internationally renowned experts Wide range of training courses with hands-on experience to drive expertise, awareness, and innovation Customized in-house training courses and workshops available
PDA Education Program 12 June 2017 Quality by Design (QbD) for Biopharmaceuticals One-Day Training Course 12 June 2017 Cleaning and Disinfection One-Day Training Course 15 – 16 June 2017 Introduction to Aseptic Processing Principles Two-Day Training Course 15 – 16 June 2017 Practical Approach to Quality Culture Two-Day Training Course
ONE-DAY TRAINING COURSE
Quality by Design (QbD) for Biopharmaceuticals A practical approach
Overview The principles and practices of Quality by Design (QbD) for biopharmaceutical, biosimilar, and other biologic manufacturing processes are here now, with regulatory authority expectation for market approval submissions to include at a minimum the quality target product profile (QTPP), identification of critical quality attributes (CQAs) and justification of critical process parameters (CPPs). The principles and practices of QbD are applicable for both in-house and contracted-out biopharmaceutical development, manufacturing and testing. Unfortunately, there is so much confusion today about what QbD is and isn’t: What is so different about QbD? Must QbD include a thorough multi-variate analysis of design space? Does QbD guarantee regulatory freedom to independently make future manufacturing process changes? Does QbD mean no future manufacturing problems? Before launching into QbD, biopharmaceutical manufacturers must first have a firm understanding of the unique challenges facing biologics, and then a complete understanding of the International Council on Harmonization (ICH) strategic guidances (Q8, Q9, Q10, Q11) for this enhanced approach. Practical suggestions to help your company apply QbD to your biopharmaceutical, biosimilar or other biologic development program will be provided by examining what has worked already for other companies. The six (6) key steps of QbD will be examined and discussed carefully. Also, this course will identify the limitations of the QbD approach.
Who Should Attend:
Learning Objectives:
This course is designed specifically for those involved or interested in an enhanced control system for biopharmaceuticals, including
Upon completion of this course, you will be able to:
• • • • • •
Senior Management Directors and Managers/Supervisors QA/QC Regulatory Affairs Manufacturing Process Development
•
Explain the importance and underlying principles of an effective QbD approach for biopharmaceuticals, biosimilars and other biologics
•
Gain a firm understanding to apply the principles of QbD to all types of biologic products – recombinant proteins, monoclonal antibodies, biosimilars, gene therapy products and cell-based medicines
John Geigert, PhD, BioPharmaceutical Quality Solutions John Geigert is President of BioPharmaceutical Quality Solutions, which for the last 15 years has specialized in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry. He has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry. He has held senior management positions as Vice President of Quality at both IDEC Pharmaceuticals Corporation in San Diego and Immunex Corporation in Seattle, and he was Director of Product Development at Cetus Corporation in Berkeley. At these companies, he helped lead the CMC efforts to obtain regulatory approvals for 6 biopharmaceutical products now commercially available in the U.S. and in Europe. John Geigert has served on the PDA Board of Directors, currently chairs the PDA Biotech Advisory Board, and has served as an expert member of the USP Biotechnology Committee. He is the author of the book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics (2nd Edition). John Geigert obtained his B.S. in Chemistry from Washington State University and his Ph.D. degree in Organic / Analytical Chemistry from Colorado State University. 18
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TRAINING COURSE AGENDA 7 June 2017
Monday, 12 June 2017
9:00 – 18:30
9:00
Welcome & Introduction
9:10
Applying QbD Requires Understanding the Challenges Due to the Complexity of Biologics
10:30
Coffee Break
11:00
Applying QbD Requires Understanding the Systematic Principles Laid Out in ICH Q8, Q9, Q10 and Q11 – Quality Risk Management, Knowledge Management
12:30
Lunch Break
13:30
Six Steps to an Effective Implementation of a Biopharmaceutical Control System
15:00
Coffee Break
15:30
Practical Examples Illustrating Successfully Applied QbD For Biopharmaceuticals
18:30
End of Course
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TRAINING COURSE AGENDA 7 June 2017
Monday, 12 June 2017 9:00
Welcome & Introduction
Module 1: Outsourcing Strategies for EU and US 9:15
• • • •
How to set up your strategy? When is the right time for outsourcing? Which are the key-aspects to be considered at different stages of development? What is essential from a GMP and regulatory perspective in EU and US?
10:45
Coffee Break
Module 2: Process Transfers of Drug Substances & Drug Product 11:15
• • • •
How to plan a Process Transfer? What are the essential parts of Technology Transfer Package? How can you minimize Risks and Delays? Typical Examples (Drug Substance, Tablets, Sterile Product)
12:45
Lunch Break
Module 3: Workshop: Project Management for a Typical Technology Transfer Project 13:30
• • •
Planning Key-Milestones Documentation
15:15
Coffee Break
Module 4: Outsourcing: QC and QA-Perspective 15:30
• • • • •
When will you outsource analytics and why? How will you choose your Contract Lab? What are the points to be considered for an analytical transfer? What needs to be considered for the GMP-Agreement? What is essential for inspections?
Module 5: Outsourcing: Success Factors
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16:30
• • • •
How will you select and evaluate your potential partners? How will you monitor the transfer activities? How will you cope with unplanned changes? How can you manage your project successfully?
17:15
Summary of the Day
17:30
End of Training Course
pda.org/eu/supplychain-api
9:00 – 17:30
ONE-DAY TRAINING COURSE
Cleaning and Disinfection A practical approach 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.
Who Should Attend:
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.
Production management Operators responsible for/involved in C&D Quality/Microbiology management Quality personnel involved in C&D
Monday, 12 June 2017 9:00
9:00 – 18:00
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
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 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. pda.org/cleaning-and-disinfection2017
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TWO-DAY TRAINING COURSE
Introduction to Aseptic Processing Principles Overview This course is intended to provide individuals with an understanding of the fundamental principles governing aseptic processing. The course will cover the systems associated with aseptic processing and how they work together to help ensure a sterile product. The Key Topics are:
• • • • • • •
Facility/Equipment/Process Design Environmental Monitoring Gowning/Aseptic Technique Sterilization Cleaning and Disinfection Process Simulations (Media Fills) Recent Regulatory Activity
Who Should Attend:
Learning Objectives:
This course is ideal for those who are either new to the industry or new to aseptic processing. Participants from disciplines such as mechanics, HVAC technicians, cleaning and disinfection personnel, and microbiology technicians will also benefit from this course even if they are minimally involved in the aseptic manufacture of drugs, but need to understand the systems associated with it.
Upon completion of this course, you will be able to:
• Be able to describe some of the critical elements (“Hot Topic”) associated with aseptic processing
• Be able to discuss basic concepts of cleanroom operation and monitoring
• Have an understanding of the current regulatory concerns and industry interpretations of the regulations
Guenther Gapp, PhD, Independent Consultant, Gapp Quality GmbH Since 2013, the microbiologist Guenther Gapp has been working as an independent consultant for different clients around the globe, and has been engaged in more than 30 projects: recently at US- Lachman Consultants as “Aseptic Processing Expert”, e.g. in assignments for remediation of companies cited with a Warning letter. In the previous steps of his career, he served in the pharmaceutical industry during 20 years as Head of QA/QC Microbiology department and Sterility Assurance Expert and Troubleshooter in global projects and supplier audits. During this period, he gained in-depth experience in Aseptic Processing key elements, training and motivation of operators, media fill practices of finished dosage forms and bulk products, environmental monitoring, rapid testing methods and regulatory agency audits. Guenther has been a subject matter expert in more than 20 FDA audits. He also created a new sterile risk assessment tool to identify and reduce the microbial contamination and compliance risk of aseptically prepared, sterile products, and this method is used now worldwide. The publication of this Risk Assessment tool won him the 2011 PDA Journal of Pharmaceutical Science and Technology Award. He has been a speaker at several PDA conferences in the past years. Since 2017 he is also a member of the 2017 PDA Annex 1 Workshop committee and Task Force, which deals with the revision of the important European guidance Eudralex Annex 1 “Manufacture of Sterile Medicinal Products”. A brand new initiative is to assess and improve the current hygiene conditions and aseptic working practices in local Austrian hospitals, aiming to reduce the threatening “nosocomial infection rates” of patients. 22
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TRAINING COURSE AGENDA 7 June 2017
Thursday, 15 June 2017 9:00
9:00 – 18:00
Introductions / Scope • Welcome & Introduction • Aseptic Processing vs. Terminal Sterilization • Describe the importance of each component of aseptic processing • Discuss how the components of aseptic processing are interrelated
Friday, 16 June 2017 9:00
9:00 – 17:00
Environmental Monitoring • Environmental monitoring techniques for various applications. • Discuss choosing monitoring locations. • Discuss alert and action limits. Coffee Break
Facility Design / HEPA Filters / Differences between Isolators and Conventional Processing • Identify key components of facility design and controls • Define regulatory requirements of critical and clean area control parameters • Discuss HEPA filter construction / function / testing • Identify differences between aseptic processing in isolators and conventional lines
CIP / SIP / Depyrogenation • Describe how CIP and SIP can lower risk of contamination and minimize manual interventions • Identify key CIP / SIP process steps and types of equipment that can be CIP / SIP’d • Discuss principles of depyrogenation and its importance to injectable products
Coffee Break
Aseptic Processing Simulation Studies (Media Fills) • Review background and objective of APS • Review elements of study design • Best practices how to keep overview of routine operations and media fills • Brief Introduction to the usage of Risk Assessments for making better decisions
Working in Unidirectional Flow and Good Aseptic Working Practices • Describe concepts of airflow and “first air” • Understand risk of product contamination when not following first air principles • Real- Life examples about good and bad practices in cleanrooms (videos / pictures) Lunch Break Basic Microbiology • Describe qualities and types of microorganisms • Describe modes of microorganism transport • List growth requirements and sources • Explain methods and importance of identification • Introduction to Pharmaceutical Water Systems: what are the contaminations risks and points to consider in monitoring
Lunch Break
Coffee Break Regulatory Trends and a Summary of Hot Topics in Aseptic Processing • Recent trends in regulatory citations End of Training Course
Coffee Break Cleaning and Disinfection / Bio-Decontamination • List appropriate application methods • Describe the importance of cleaning and disinfection • Understand the basis of chemical selection use and application • Detail the proper order of cleaning • Describe bio-decontamination methods for isolator / barrier systems Gowning, Personnel Qualification and Aseptic Technique and Cleanroom Behavior • Explain acceptable personnel behavior • Discuss what should be included in personnel qualification program • Describe why training and qualification minimize contamination End of Day 1
pda.org /eu/TCAseptic2017
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TWO-DAY TRAINING COURSE
Practical Approach to Quality Culture Overview A good quality culture is established when all employees starting from CEO to shop floor workers are accountable for quality. The following attributes are important indicators for quality culture: management communication emphasizing that quality is everyone’s responsibility, established quality improvement objectives, quality topics included in relevant meetings, and an implemented error prevention process. These quality attributes are related to management responsibility and are elements of the continuous improvement of the pharmaceutical quality system as mentioned in the ICH Q10 guideline. Quality culture is a key management element for success. However, quality culture does not establish itself but requires empowerment, communication and daily quality awareness.
Who Should Attend:
Learning Objectives:
Functions:
This training course is interactive, hands-on, and will empower you to measure, develop and improve the quality culture of your company:
• • • • • •
Middle Management Managers with employee responsibility Group Leaders Department Heads Directors Executive Level
•
Learn to measure quality attributes and quality behaviors
•
Identify weaknesses and deficits in quality behavior
•
Investigate root causes and define effective CAPAs for improvement
•
Optimize your measures with respect to cost, time and quality
Departments: • • • • • • • •
Quality Assurance Quality Control Production Purchasing Regulatory Affairs R&D Human Resources Controlling
Thomas Krieger, PhD, KU-Pharma Consulting Thomas Krieger is founder and CEO of Krieger Unternehmensberatung - Pharma (KU-Pharma) since 2009. KU-Pharma is mainly specialized on providing quality consulting for the pharmaceutical industry. In addition, KU-Pharma is providing career-readiness-training to high-potentials and coaching to managers who take on new tasks or assume new legal functions according to the drug law. Thomas studied pharmacy and obtained his Ph.D. degree in Pharmaceutical Chemistry from the University of Tuebingen, Germany. He graduated as specialized pharmacist of Pharmaceutical Analysis. Since 25 years he holds the legal qualification and has professional experience as a Qualified Person pursuant to Directive 2001/83/EC. During 20 years Thomas Krieger has held different legal functions according to the drug law and various senior management and leadership positions in quality control, quality assurance, regulatory affairs and scientific departments. He worked for several pharmaceutical companies within the range from Global Players with more than 50,000 employees to private owned companies with less than 100 employees.
Martin Haerer, Senior Director R&D/Qualified Person,Holopack Verpackungstechnik GmbH After the Ph.D. in Pharmacy, Martin started his career at Holopack Verpackungstechnik in 1990. In the following years, he managed different projects in Production, Quality Control and Quality Assurance to improve the Quality System and Production. In 2006 he was appointed Production Manager and Qualified Person. Currently he is responsible for Business Development, Technology Transfer and Research, and still acting as Qualified Person with QA responsibilities. Martin was voted Member of the Board of the BFS-IOA Association as Regulatory Officer. He is member of the German QP Association and Board Member of Federal German Pharmacist Advanced Training Organisation (BAK).
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pda.org/eu/quality-culture2017
TRAINING COURSE AGENDA 7 June 2017
Thursday, 15 June 2017
9:00 – 17:45
Friday, 16 June 2017
9:00 – 16:30
9:00
Welcome & Introduction
9:00
Recap of Day 1
9:10
Lecture 1: Definition: What Does Quality Mean?
9:15
Interactive Session 4: Exercise
9:30
Interactive session 1: Where Do We Find Quality Culture?
10:00
9:45
Lecture 2: Quality Behaviors • What are quality behaviors? • What are “good” quality behaviors? • What are “bad” quality behaviors? • How are they measured?
Lecture 5: Principles of CAPA • What are effective CAPA? • What are efficient CAPA? • How and when to measure effectiveness of CAPA? • What to do in case of re-occurrence?
11:00
Coffee Break
11:30
Interactive session 5: Exercise
12:15
Lecture 6: Cost-Time-Quality Dilemma • Total quality cost • Develop understanding for triangle Cost-Time-Quality • What is the “ideal” point within that triangle? • What are the consequences of the 3 extreme positions [Point A: 0% Time and cost, 100% quality; Point B: 0% time and quality, 100% cost, Point C: 0% cost and quality, 100 % time] • Value of well-done investigations
13:00
Lunch Break
14:00
Lecture 6 (cont.): Cost-Time-Quality Dilemma • Review CAPA from interactive session 5 in terms of cost
14:30
Lecture 7: What is an Ideal Quality Culture in a Company?
15:15
Interactive Session 6: Exercise
16:15
Q&A
16:30
End of Training Course
10:30
Interactive session 2: Quality Behavior with Interactive Exercise
10:45
Coffee Break
11:15
Interactive Session 3: Assessment Exercise • Self-assessment of own company • Interpretation of PDA survey results • What does this result mean for pharma industry in general?
12:15
Lunch Break
13:15
Lecture 3: Investigation Principles • Which functions should be in the investigation team? • Which skills are necessary for investigation team members? • How to identify the root cause? • What is the right extend and width of an investigation?
14:45
Coffee Break
15:15
Lecture 4: Toolbox for Improvement of Quality Behaviors • Communication • Risk management • Project management • Stakeholder analysis • SIPOC method • KPI/quality metrics • Fishbone diagram • 5 W questions • Fault tree • Advantage and disadvantage of tools
17:45
End of Day 1
pda.org/eu/quality-culture2017
25
HILTON HOTEL BERLIN
INFORMATION
VENUE Hilton Berlin Mohrenstraße 30 10117 Berlin Germany Tel: +49 30 20 23 00 http://hilton-berlin.hotel-in-berlin.org/
GENER AL ADDRESS PDA Europe gGmbH Am Borsigturm 60 13507 Berlin, Germany Tel: +49 30 4365508-0 Fax: +49 30 4365508-66
Special Rates PDA Europe has reserved a limited number of bedrooms until the 14 May 2017. Book your group rate for PDA. Single Room 189€ per room and night Double Room 209€ per room and night Housing at the selected hotel will be in high demand, so we strongly recommend making your reservations early.
S PEC I A L R E QU I R E M E N T S If you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific questions can be directed to registration-europe@pda.org
D I R EC T I O N S
HILTON HOTEL BERLIN
© Google For directions click on the picture, scan the QR-code or go to https://goo.gl/maps/7g4fN3ARyGk
CO N TAC T I N FO R M AT I O N Registration Customer Care Tel: +49 30 4365508-10 registration-europe@pda.org
Special offer: Discounted travel with Lufthansa Group Airlines Lufthansa Group Partner Airlines offer a comprehensive global route network linking major cities around the world. We offer special prices and conditions to participants, visitors, exhibitors, invited guests as well as employees of the Contracting partner and their travel companions. To make a reservation, please click on www.lh.com/event-flight-booking and enter the access code DEZJPRG in the "Access to Your Special Lufthansa Offer" area. This will open an online booking platform that will automatically calculate the discount offered or provide you with an even better offer if another promotional fare is available. NOTE: Pop-ups must be enabled otherwise the booking platform window will not open. These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by sending an email to lufthansa.mobility@dlh.de and providing the access code as a reference.
Conference Inquiries Melanie Decker Director Events & Exhibitions decker@pda.org Conference Program Inquiries Sylvia Becker programs-europe@pda.org Education Program Inquiries Elke von Laufenberg training-europe@pda.org Exhibition / Sponsorship Inquiries Nadjeschda Gomez-Stahl expo-europe@pda.org pda.org/eu-AnnualMeeting2017
27
2nd PDA Europe Annual Meeting
Registration Form Page 1
13-14 June 2017 | Berlin | Germany
This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.
Your registration is only complete upon filling in and submitting both pages of this form.
1
Registration All fees given in Euro, excluding VAT (7 %)
13-14 June
Conference only
Conference Fee
2nd PDA Europe Annual Meeting
PDA Member
1595
**Nonmember
1895
* Early Bird 700 â&#x201A;Ź **Regulatory/Academic
800
Poster Presenter please mark here (written approval required, conference fee applies) 12 June
Pre-Conference Workshop
Revision of Annex 1
12 June
Pre-Conference Workshop
Business Opportunities Iran 12 June
One-Day Training Course
One-Day Training Course
Two-Day Training Course
Introduction to Aseptic Processing Principles 15-16 June
695
Nonmember
895
Workshop Fee
Two-Day Training Course
Practical Approach to Quality Culture
295
Training Course Fee All Participants
Quality by Design for Biopharmaceuticals 15-16 June
PDA Member
All Participants
Cleaning & Disinfection 12 June
Workshop Fee
845
Training Course Fee All Participants
845
Training Course Fee All Participants
1495
Training Course Fee All Participants
1495
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. **Registration fee includes a one-year PDA membership if no further special discount is granted. If you do not wish to join PDA and receive the benefits of membership, please check here (same rate applies).
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 Antje Petzholdt at registration-europe@pda.org. Other discounts cannot be applied.
Discount for Exhibiting Companies
Join PDA and receive the Membership Rate Today! Please go to: www.pda.org/membership
Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 1250 Euro per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount).
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pda.org/eu-AnnualMeeting2017
2nd PDA Europe Annual Meeting
Registration Form Page 2
13-14 June 2017 | Berlin | Germany
This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.
3 WAYS TO REGISTER
1 ONLINE: pda.org/eu-AnnualMeeting2017 2 FAX: +49 30 4365508-66 3 EMAIL: registration-europe@pda.org
1 Your Contact Information
If this form is an update to a previously submitted form, please check here. Mr.
Ms.
Dr.
I want to become a PDA Member. Please send me a subsription form
Nonmember PDA Member
Name (Last, First, MI) *
ID Number
Job Title * Company*
Department
Mailing Address City
Postal Code
Country
Email *
Business Phone
Fax
Substituting for (Check only if you are substituting for a previously enrolled colleague; a nonmember substituting for member must pay the member ship fee.)
* This information will be published in the conference attendee list. Should you not wish us to publish these details, please contact us.
2 Information about Visa Matters
• All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
• All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
• Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
3 Payment Options By Bank Transfer Beneficiary: PDA Europe gGmbH IBAN: DE73 1007 0024 0922 8735 00 BIC (SWIFT-Code): DEUTDEDBBER Bank Address: Deutsche Bank, Welfenallee 3-7, D-13465 Berlin, Germany
Your Company VAT I.D.:
By Credit Card
Purchase Order
American Express
MasterCard
VISA
Purchase Order Number
For your credit card information safety: Please send your details by fax only. Billing Address:
Same as contact information address above. If not, please send your billing address to: registration-europe@pda.org PDA Europe VAT I.D.: DE254459362
This number starts by your country code with two characters (example: PDA Europe’s country code starts with: DE | followed by the number)
Your registration is only complete upon filling in and submitting both pages of this form.
Date
Mandatory Signature
CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded once PDA Europe has sent a written invoice by mail to you. A letter of confirmation will be sent to you within one week once payment has been received. You must have this written confirmation to be considered enrolled for this PDA event. PDA Europe reserves the right to deny access to anyone unable to provide written confirmation that all dues have been fully settled. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a charge of € 100 per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 13 May 2017, you will receive a full refund minus a 150 € excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at registration-europe@pda.org or fax to +49 30 4365508-66. DOCUMENTATION: With your signature you give complete picture usage right to PDA and allow to film your exhibition space and intervention in the event, including the recording of your presentation for video purposes (with your slides, voice and image). This right extends also to the use of the resulting images in film documentation for webinars and similar items produced by PDA.
pda.org/eu-AnnualMeeting2017
29
2017 PDA EUROPE CONFERENCES 30 May – 1 June
Virus & TSE Safety Forum
Dubrovnik, Croatia
13 – 14 June
2nd PDA Europe Annual Meeting
Berlin, Germany
27 – 28 June
Advanced Therapy Medicinal Products
Valencia, Spain
19 – 20 September
Pharmaceutical Freeze Drying Technology
Cologne, Germany
26 – 27 September
Particles in Injectables
Berlin, Germany
26 – 27 September
10th Workshop on Monoclonal Antibodies
Berlin, Germany
10 – 11 October
Pharmaceutical Cold & Supply Chain Logistics
Prague, Czech Republic
7– 8 November
The Universe of Pre-filled Syringes and Injection Devices
Vienna, Austria
21 – 22 November
Outsourcing & Contract Manufacturing
Munich, Germany
Subject to change
For latest info: pda.org/pda-europe
Shortlist 7 June 2017
Events with additional Education Program. More information – pda.org/pda-europe
General Information PDA Europe gGmbH Am Borsigturm 60 13507 Berlin, Germany Tel: +49 30 4365508-0 Fax: +49 30 4365508-66 info-europe@pda.org
Connecting People, Science and Regulation ®
www.pda.org/pda-europe