Visual Inspection PDA Europe Interest Group Meeting. 1 March 2016 Berlin Germany. The Parenteral Drug Association presents:

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1 The Parenteral Drug Association presents: 2016 PDA Europe Interest Group Meeting Visual Inspection 1 March Interest Group Meeting 2-3 March Introduction to Visual Inspection 4 March Particle Identification 1 March 2016 Berlin Germany pda.org/eu/igvisual2016

2 SCHEDULE AT A GLANCE 1 March 9:00 17:30 Interest Group Meeting Visual Inspection IG Meeting 2-3 March 9:00 18:00 9:00 16:30 An Introduction to Visual-Inspection: A Hands-on Course Training Course 4 March 9:00 17:30 Particle Identification in Parenterals Training Course (Bus Transfer from Hotel am Steinplatz to rap.id GmbH and return provided, duration about 45 min) For latest information, please visit: pda.org/eu/igvisual2016 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 increase 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 SONNENHOF 2 pda.org/eu/igvisual2016

3 OVERVIEW Interest Group Meeting Visual Inspection Focus Topics Difficult to Inspect Containers (USP 790, Lyoproducts, Techniques and Procedures) Particle Load on Stoppers/Elastomers Discussion Topics Focus Discussion Topic: Risk-based Approaches for Visual Inspection Other Topics: All Related to Visual Inspection Interest Group meetings are primarily designed to exchange experience and expertise, therefore, Q & A and discussions are most prominent in these meetings. There are presentations on the focus topics. Short presentations covering additional information fitting the scope of the Interest Group are welcome. Please contact laufenberg@pda.org to submit your topic. Register by 25 Sept 2016 and SAVE! 2016 PDA Europe Visual Inspection Forum October 2016 Berlin Germany October Conference, Exhibition, Education Program europe.pda.org/visualinspection2016 pda.org/eu/igvisual2016 3

4 TWO-DAY TRAINING COURSE An Introduction to Visual Inspection A hands-on training course Overview This training course covers the fundamentals of visual inspection methods and their application to injectable products. The detection and identification of visible particles is a key part of the course content, though container and closure defects are discussed as well. Students combine classroom review of current regulatory requirements and inspection methods with hands-on laboratory exercises to develop and practice practical inspection skills. The skills developed through this combination of classroom and laboratory exercises may be applied to manual human inspection, semi-automated and automated machine inspection methods. This is also an excellent opportunity to discuss your specific inspection questions and challenges with expert instructors. Who Should Attend Injectable Drug Product Manufacturing Professionals and Management Quality Professionals and Management Validation and Manufacturing Engineers Technical Support Staff Product Development Scientists Inspection Equipment Manufacturers Learning Objectives Upon completion of this course students will be able to: Understand current global regulatory and compendial requirements for visual inspection Understand patient risk associated with visible particles in injections Implement and technically sound and compliant inspection process Assess inspection performance John G. Shabushnig, PhD Principal Consultant, Insight Pharma Consulting, LLC John Shabushnig is the founder of Insight Pharma Consulting, providing expert guidance in all aspects of visual inspection. He has over 30 years of industry experience starting as a Research Scientist at The Upjohn Company and most recently as a member of Pfizer s Global Quality Operations where he was responsible for providing microbiology and aseptic manufacturing technical support. John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University. He is an active member of the Parenteral Drug Association (PDA), having served on the Board of Directors ( ) and as Chair ( ) and is the founder and leader of the Visual Inspection Interest Group. He serves on the United States Pharmacopeia (USP) Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He has published and presented numerous papers on the subjects of spectroscopic analysis, process analytical technology (PAT), rapid microbiological test methods and the visual inspection of pharmaceutical products. 4 pda.org/eu/igvisual2016

5 TRAINING COURSE AGENDA Wednesday, 2 March :00 18:00 9:00 Welcome and Introduction Why We Inspect Patient Safety Regulatory Requirements Compendial Requirements 10:30 Coffee Break 11:00 Inspection Methods and Technologies Critical Parameters (lighting, time, contrast and motion) Manual Visual Inspection (MVI) Semi-Automated Visual Inspection (SAVI) Automated Visual Inspection (AVI) 12:30 Lunch Break 13:30 Particle Identification 14:30 Laboratory Exercise: Manual Visual Inspection Light Measurement Assessment effect of changing critical variables - Time (10 sec vs. 20 sec) - Lighting (2,500 lux vs. 1,250 lux) - Motion/Agitation (with vs. without) 15:30 Coffee Break 16:00 Continue Laboratory Exercise 17:30 Wrap-up Discussion / Q&A 18:00 End of Day 1 Thursday, 3 March :00 16:30 9:00 Inspection Data Review From previous day s laboratory exercise 10:00 Defect Classification Strategies Risk classification definitions Critical, Major and Minor defects 10:30 Coffee Break 11:00 Acceptance Sampling Sampling Plan Variables - Sample Size - AQL and UQL Common Standards - ANSI/ASQ Z1.4 - ISO :00 Inspector Selection and Qualification Vision Screening Initial Training Initial Qualification Requalification 12:30 Lunch Break 13:30 Inspection Strategies Reinspection 2-Stage Inspection Focused inspection Empty Vial Inspection 14:00 Inspection Validation Inspection performance Assessment - Knapp Method Acceptance Criteria 14:30 Coffee Break 15:00 Mythbusting Common misperceptions in visual inspection 15:30 Wrap-up Discussion / Q&A 16:30 End of Training Course Markus Lankers, PhD Managing Director, rap.id GmbH Markus Lankers is one of the co-founders of rap.id Particle Systems GmbH a company that develops manufactures and sells rapid particle identification systems. Within rap.id Markus is responsible for research and development of specific characterization method of particulate analysis and manages two dedicated particle characterization service labs in Germany and the US. Prior to this position he worked as scientist in different development departments with Schering AG, Berlin, Germany. He published and presented work in the field of particle characterization and spectroscopic analysis. As an active member of the PDA, he helped to establish the PDA Visual Inspection Interest Group in Europe and to setup the first company independent Visual Inspection Trainings Course. He served as program co-chair for PDA Visual Inspection Forum in Europe and USA. pda.org/eu/igvisual2016 5

6 ONE-DAY TRAINING COURSE Particle Identification in Parenterals Overview Particulate matter contamination has become the #1 reason for recalls of the US-FDA. This one day comprehensive training course taught by industry leading experts will offer strategies for the implementation of a cost effective control through mandatory compliant root-cause investigations. The program will provide the foundational information needed to properly control, document and investigate foreign particulate matter in parenteral drugs. It will provide the perfect balance of hands-on laboratory and lecture training, equipping you with knowledge, tools and actual experience you can apply immediately on the job. Furthermore the course will provide insights and practical guidance for the quality teams to develop a cost effective strategy for the critical routine root cause investigations to ensure compliance with current good practices. With a strong emphasis on the hands-on part the participants will learn the theoretical background of useful microscopic and spectroscopic techniques. Pre-isolation: in-situ Microscopy (inverse microscope) and other means of video microscope to visualize and document the particulate matter without opening the container. Isolation: Tools and precautions to minimize cross contamination for the isolation of the micro particles. After isolation: Pro s and Con s of Polarized Light Microscopy and micro-spectroscopic techniques such as: Raman, Laser Induced Breakdown Spectroscopy, LIBS and IR with ATR extension and SEM EDS will be critically discussed. In the Hands-on part each of the attendee works in groups of maximum 5 people on their individual particulate matter reject sample. They will characterize the particulate matter in the closed container and document the particle with micro-imaging techniques. After isolating the particle in a clean-bench the attendees will use Raman, LIBS and IR/ATR to obtain high quality spectra of the particles and will also match these spectra with pre-recorded library spectra. Finally the different steps of the investigation will be summarized and combined with a critical comparison of the different means of particle characterization the attendees will be able to evaluate results from CMC reports with their own experience. Who Should Attend This course is designed specifically for those involved in or interested in the manufacture and control and CMC regulatory issues of biopharmaceuticals, including Senior Management, Directors and Managers/Supervisors, QA/QC, Regulatory Affairs, Manufacturing and Process Development Personnel Learning Objectives Upon completion of this course, you will be able to: Understand the principles of particulate matter characterization in the closed container by means of micro imaging photo documentation as well as visual observations. Explain the strategy of compliant particle root cause investigations including reference material library building. Understand and gauge the results of particulate material identification from micro spectroscopic methods such as: Raman, IR with ATR, EDS and LIBS. Markus Lankers, PhD Managing Director, rap.id Particle Systems GmbH Markus Lankers is one of the co-founders of rap.id Particle Systems GmbH a company that develops manufactures and sales rapid particle identification systems. Within rap.id Markus Lankers is responsible for research and development of specific solution of particulate analysis. Prior to this position he worked as scientist in different development departments with Schering AG, Berlin, Germany. He has published and presented work in the field of analytical methods for particle analysis and spectroscopic analysis. As an active member of the PDA, he helped to establish the Visual Inspection of Parenterals Interest Group in Europe and to setup the first company independent vis. Inspection trainings course. He served as program cochair for Scientific Conference on Visual Inspection of Partenterals in Europe and USA. 6 pda.org/eu/igvisual2016

7 Training Location: rap.id Particle Systems GmbH Köpenicker Strasse 325 House 11/ Berlin Germany TRAINING COURSE AGENDA Friday, 4 March :00 17:30 At rap.id GmbH, Berlin 8:00 Bus Transfer from Hotel am Steinplatz to rap.id GmbH (optional) 09:00 Welcome & Introduction 09:30 Regulatory Update Covering USP 790 and 1790 Importance of Particle Classification and Characterization 10:15 Coffee Break 10:45 Strategies for Particle Classification in Process Lifecycle Characterization in Closed Container Particle Isolation 11:30 Microscopic Characterization and Identification Use of Spectroscopic Tools 12:30 Lunch Break 13:30 Hands on: Visual Inspection, Classification, Isolation, Spectroscopy 15:30 Coffee Break 16:00 Common Sources of Particulates Root Cause Investigations 17:30 End of Training Course and Bus Transfer from rap.id GmbH to Hotel am Steinplatz (optional - duration approximately min.) Oliver K. Valet, PhD Managing Director, rap.id Particle Systems GmbH Oliver K. Valet is one of the co-founders of rap.id Particle Systems GmbH a company that develops manufactures and sells rapid particle identification systems. Within the last 15 years their patented technology fuses particle isolation, imaging analysis and spectroscopic technology together to powerful investigation tools. Streamlining particle contamination identification and particle characterization. Within rap.id Oliver is responsible for the product development and their worldwide marketing and sales. From the contract testing work performed at both rap.id sites in Berlin and Princeton, New Jersey, Oliver has more than a decade experience in the field of industrial and environmental chemical analysis on particles. As an active member of the Respiratory Drug Delivery (RDD), the Royal Chemical Society, Parenteral Drug Association (PDA), the American Association of Pharmaceutical Science (AAPS) and the Apothekerverband (APV) he has published his work continuously and presented on various conferences. pda.org/eu/igvisual2016 7

8 INFORMATION Antje Petzholdt Membership Management Melanie Decker Director Events & Exhibitions Elke von Laufenberg Manager Training & Education Membership Management Interest Group General Event Information Call for Papers Committee Management Speaker Management Conference Program Education Program Faculty Management Contacts For additional conference information please contact: General Address PDA Europe ggmbh Am Borsigturm Berlin, Germany Tel: Fax: Venue Hotel am Steinplatz Steinplatz Berlin Germany Tel: Fax: berak-hotel-am-steinplatz-autograph-collection Special rates PDA Europe has reserved a limited number of rooms until the 1 February Single Room 169 per night Double Room 189 per night including breakfast, VAT, WLan and Service Charge City tax applies. The Parenteral Drug Association presents: st PDA Europe Annual Meeting THE FUTURE IN INJECTABLES PDA Europe Education Program 30 June - 1 July Root Cause Investigation 30 June - 1 July Development Pre-Filled Syringe II 30 June Test Methods Pre-Filled Syringes 30 June Cleaning and Disinfection II June 2016 Estrel Hotel Berlin Berlin Germany 8 pda.org/eu/igvisual2016

9 Interest Group Meeting Visual Inspection 1 March 2016 Berlin Germany 4 WAYS TO REGISTER ONLINE: FAX: petzholdt@pda.org MAIL: PDA Europe, Am Borsigturm 60, Berlin, Germany Your Contact Person is Antje Petzholdt at PDA Europe petzholdt@pda.org This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing. 1 Your Contact Information If this form is an update to a previously submitted form, please check here. Mr. Ms. Dr. Nonmember I want to become a PDA Member. Please send me a subsription form Name (Last, First, MI) * PDA Member ID Number Job Title * Company* Department Mailing Address City Postal Code Country * Business Phone Fax Substituting for (Check only if you are substituting for a previously enrolled colleague; a nonmember substituting for member must pay the membership fee.) * This information will be published in the conference attendee list. Should you not wish us to publish these details, please contact us. Information about Visa Matters 2 Registration No PDA membership included 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 All fees given in Euro and excluding VAT (7 %) Interest Group Meeting (1 March) net All Participants 400 Two-Day Training Course (2-3 March) An Introduction to Visual-Inspection: A Hands-on Course All Participants 1495 One-Day Training Course (4 March) Particle Identification in Parenterals All Participants 795 By Credit Card (one week prior to event) American Express MasterCard VISA For your credit card information safety: Please send your details by fax only ( ) or register online. By Bank Transfer Beneficiary: PDA Europe ggmbh IBAN: DE BIC (SWIFT-Code): DEUTDEDBBER Bank Address: Deutsche Bank, Welfenallee 3-7, D Berlin, Germany By Purchase Order Purchase Order Number 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. 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 petzholdt@pda.org. Other discounts cannot be applied. PDA Europe VAT I.D.: DE Billing Address: Your Company VAT I.D.: Same as contact information address above. If not, please send your billing address to: petzholdt@pda.org This number starts by your country code with two characters (example: PDA Europe s country code starts with: DE followed by the number) Discount for Exhibiting Companies Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 995 Euro per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount). This special rate does not include one-year PDA membership. 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. You must have a written confirmation (including invoice) to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. Payment must be received or guaranteed by Purchase Order or credit card details on 1st day of event, at the very latest. 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 1 February 2016, 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 info-europe@pda.org or fax to 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/igvisual2016 9

10 Helpful Hints When Registering for PDA Europe Events MAKING IT EASIER FOR BOTH OF US 1 Please include your member ID number on registration form if available/known If uncertain about your member ID number and/or your membership status, call or Ms. Antje Petzholdt petzholdt@pda.org 2 Do not send money in advance Please wait until we send our invoice to you. It is helpful to reference our invoice number in your bank transfer details. 3 Complete and sign the event registration form Please note the registration and cancellation policies at the bottom of the form. 4 Purchase Orders Registration cannot be completed by sending Purchase Order alone. A Purchase Order is only accepted if a complete registration form is enclosed or follows very soon. 5 Please state VAT ID number if European-based Company This number starts by your country code (example: PDA Europe s VAT ID number = DE ) 6 Please state the correct billing address on the registration form This is particularly important if billing address and site address are different. Contact your accounting department for correct address and company name. There could be special requirements for accounting. Changes in the billing address (if induced by participating company) will be charged 25,- if imposed 3 weeks prior to the start of the event. 7 Confirmation of your registration Credit card charges are confirmed immediately if successfully approved. Bank transfers are confirmed upon receipt of full payment. 8 Refund/Credit Notes Refunds to credit card can be done immediately if payment had been done by credit card and details are available. Refunds to bank accounts can be done if payment had been done by bank transfer and the following details are provided: a) Name of your bank b) IBAN number c) Swift/BIC code 9 Substitutions If a participant is unable to attend, substitutions are welcome at any time. Changes are free of charge until 3 weeks prior to the start of the event. After this date, there will be a charge of 50 per name change. 10 For assistance contact: Antje Petzholdt, PDA Europe Tel: petzholdt@pda.org THANK YOU FOR YOUR COOPERATION! 10 pda.org/eu/igvisual2016

11 2016 PDA EUROPE ACTIVITIES & EVENTS 22 February February February February February Pharmaceutical Water Systems Pharmaceutical Microbiology Conference Rapid Microbiological Methods Charting and Trending of Environmental Monitoring Data Control, Validation and Monitoring of Biofilms in Water Systems Berlin, Germany 1 March 2-3 March 4 March Interest Group Meeting Visual Inspection An Introduction to Visual-Inspection: A Hands-on Course Particle Identification in Parenterals IG Berlin, Germany 11 April April 14 April April April April Interest Group Meeting Pre-filled Syringes Parenteral Packaging Conference Container Closure Development Extractables and Leachables Container Closure Integrity: Regulations, Test Methods, Application Good Glass Handling Practices in Parenteral Packaging IG Venice, Italy April Data Integrity London, UK April Praxis der Pharmazeutischen Gefriertrocknung Osterode, Germany 2-3 May Extractables & Leachables for Pharmaceutical Containers Bern, Switzerland 31 May - 1 June Annex 1 Berlin, Germany 6 June 7-8 June 9 June Viral Safety of ATMPs Conference Advanced Therapy Medicinal Products Conference Practical Application of GMP for Development of ATMPs Berlin, Germany June 30 June 30 June 30 June - 1 July 30 June - 1 July 1 st PDA Europe Annual Meeting Test Methods for Pre-filled Syringe Systems Cleaning and Disinfection Root Cause Investigation Development of a Pre-filled Syringe Berlin, Germany September 22 September September September September September 9 th Workshop on Monoclonal Antibodies Elastomers CMC Regulatory Compliance for Biopharmaceuticals Extractables and Leachables Introduction to Aseptic Processes Principles Statistics of Production Monitoring and Capability Rome, Italy September 29 September September Pharmaceutical Freeze Drying Technology Conference Application of a Risk-Based Approach to Freeze-Drying Processes Development of a Freeze Drying Process Strasbourg, France 5-6 October Annex 1 Dublin, Ireland 10 October October October Interest Group Meeting Pharmaceutical Cold Chain Pharmaceutical Cold & Supply Chain Logistics Good Cold Chain Practices IG Amsterdam, The Netherlands 24 October October October Particle Identification in Parenterals Visual Inspection Forum An Introduction to Visual Inspection: A Hands-on Course Berlin, Germany 8-9 November Data Integrity Berlin, Germany 14 November November 17 November November Risk-based Approach for Prevention and Management of Drug Shortages Outsourcing & Contract Manufacturing Conference Quality by Design for Biopharmaceuticals Root Cause Investigation To Be Confirmed Subject to change For latest info: europe.pda.org Shortlist 27 Jan 2016 General Information PDA Europe ggmbh Am Borsigturm Berlin, Germany Tel: Fax: Conference Information Melanie Decker Director Events & Exhibitions Tel: decker@pda.org Training Course Information Elke von Laufenberg Manager Training & Education Tel: laufenberg@pda.org Legend IG Interest Group Meeting Training Course Workshop europe.pda.org