PLEASE TYPE OR PRINT CLEARLY Member ISPE ID# _______________________ First-Time Attendee New Member Non-Member ____________________________________________________ FIRST NAME MI LAST NAME ____________________________________________________ INFORMAL BADGE NAME EMAIL ADDRESS ____________________________________________________ JOB TITLE ____________________________________________________ COMPANY ____________________________________________________ BUSINESS ADDRESS ____________________________________________________ CITY STATE/PROVINCE COUNTRY ____________________________________________________ BUSINESS TEL ____________________________________________________ EMERGENCY PHONE (For Last-Minute Meeting Updates): Cell Phone Home Phone I wish to keep my data confidential; it is given only for use by ISPE and its Chapters and Affiliates. (This excludes you from the conference attendee listing, Member Directory, and exhibitor list.) 4 WAYS TO REGISTER: ONLINE: PHONE: FAX: MAIL: www.ISPE.org +1-813-960-2105 +1-813-264-2816 ISPE, 600 N WEST SHORE BLVD., SUITE 900 TAMPA, FL 33609-1114, USA Registration is confirmed only when payment is received. Please send this registration form with payment to: ISPE 600 N West Shore Blvd, Suite 900 Tampa, FL 33609-1114 USA FEIN #59-2009272 • www.ISPE.org PAYMENT METHOD: Payment required at time of registration. Check# __________________ enclosed payable to ISPE in the amount of $ __________________ (Must be drawn on a US bank) Bill credit card: VISA MasterCard American Express ____________________________________________________ CARD NUMBER EXP. DATE CCV ___________________________________________________________ NAME OF CARDHOLDER (AS IT APPEARS ON CARD) ___________________________________________________________ CARDHOLDER SIGNATURE To Wire Payment in US Dollars: Wells Fargo Bank NA San Francisco, CA USA ISPE Acct #2000027075566 ABA #121000248 FULL EDUCATION PRICES* Type On or Before After 19 August 19 August Member US$1,950 US$2,150 Non-member** US$2,330 US$2,530 Committee US$1,465 US$1,615 Government US$700 US$700 Young Professional Member US$975 US$1,075 Student Member US$200 US$200 Academia Member US$1,465 US$1,615 **SAVE hundreds of dollars by joining and registering as an ISPE Member! To activate your membership please download a membership application at www.ISPE.org/membership. Join and return it to ISPE with this registration form . ONE-DAY EDUCATION PRICES ____________________________________________________ ZIP+4/POSTAL CODE REGISTRATION PRICING (Sunday, Monday, Tuesday, or Wednesday)* Type On or Before 19 August Member US$749 Non-member US$949 After 19 August US$849 US$1,099 ONE-DAY EXPO HALL PASS PRICES Day (Sunday, Monday, or Tuesday)* Sunday (includes opening Keynote and Reception) Monday (includes Monday Keynote and Lunch) Tuesday (includes Tuesday Lunch) Fee US$70 US$70 US$70 A LA CARTE EVENT FEES (Items below are not included in registration fee, except where indicated. All prices for A La Carte Events are the same prior to and after 19 August.) Sunday Opening Keynote and Monday Morning Keynote (open to all) Sunday Welcome Reception (included with Full and Sunday-Only Registrations) Monday Morning 5K Charity Run/Walk Monday Lunch in Exhibit Hall (included in Full and Monday-Only Registrations) Monday Young Professionals Networking Event Monday GAMP CoP 25th Anniversary Celebration Tuesday Membership and Awards Breakfast (included in Full and Tuesday-Only Education Registrations Tuesday Lunch in Exhibit Hall (included in Full and Tuesday-Only Registrations) Tuesday Night Party (included with Full Registration only) Wednesday Facility Tour at Alcon Wednesday Facility Tour at Baxalta US$0 US$60 US$25 US$55 US$55 US$150 US$45 US$55 US$200 US$55 US$55 *Please NOTE: The One-Day Education and Expo Hall Pass prices are good for one day. If you plan to attend more than one day, a full education registration must be purchased. Tuesday Night Party is not included in One-Day Education or Expo Hall Pass Registration. Fees are based on per-person pricing. Track: Information Systems Special Lunch Requirement Vegetarian Kosher __ Gluten Free TOTAL $_____________________________ SES401 GCP Regulatory Update and Why GAMP is Important for GCP Track: End-to-End Supply Chain Management __ SES501 The People’s Court: Equipment Supplier Management Debate Goes to Court Track: Innovation Forum GROUP DISCOUNT RATE: __ Bring your team to the ISPE Annual Meeting: 3 – 5 participants – Save 10% 6 – 10 participants – Save 15% 11 or more participants – Save 20% 13:45 – 15:15 Track: Facilities and Equipment Group discount applies to full education registrations only. To qualify, all registrant information must be submitted at the same time; only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. To register as a group, please contact ISPE Member Services at +1-813-960-2105. __ __ SES601 Global Regulatory and Industry Opportunity SES103 Creating Lean Laboratories Using a WorkflowCentric Design Concept SES104 Next Generation Maintenance Program Design Track: Regulatory Compliance and Quality Systems __ SES202 Process Capability: Part 2 Track: Product Development and Production Systems __ SES302 Single-Use Technology Assessment & Implementation via Retrofit of a Clinical Manufacturing Facility Track: Information Systems CONFERENCE CANCELLATIONS: Cancellations must be made in writing. If cancellations are received by 26 August 2016, a full refund, minus a $100 handling fee, will be issued. After that time, no refunds will be granted. If you are unable to attend, you may send a colleague to attend as your substitute. However, non-members substituting for a Member must pay the difference in fees prior to the start of the event. ISPE is not responsible for lost airfare due to cancellations. HOTEL: Hotel accommodations and hotel fees are separate from conference registration fees. For room reservations at the conference venue, the Atlanta Marriott Marquis, in Atlanta, GA, USA call: +1-404-521-0000. When making your reservation by phone, mention ISPE for a discounted rate of $199 single/double. This rate is good until 29 August 2016, or until the room block is full, whichever comes first. Please contact the hotel as early as possible to ensure you are in the headquarters hotel. __ SES402 Data Integrity: Kickoff and Introduction to the New GAMP Guide Track: End-to-End Supply Chain Management __ SES502 Case Studies for Drug Shortage Prevention Track: Innovation Forum __ SES602 Novel Methods, Equipment, and Technology MONDAY, 19 SEPTEMBER 2016 11:00 – 12:30 Track: Facilities and Equipment __ __ __ SES106 Rouging in Pharmaceutical Production: Part 1 SES107 Baxalta Tour Overview SES108 Ease the Integration of Packaging Lines Track: Regulatory Compliance and Quality Systems __ SES203 Clinical Relevance Track: Women in Pharma __ SES700 Women in Pharma: Part 1 Track: Product Development and Production Systems __ SES303 Continuous OSD Manufacturing Overview Track: Information Systems EDUCATION SESSION SELECTIONS: We ask that you select the education sessions you plan to attend (in accordance with the type of registration you selected, above) from the choices in the program listed below. Detailed information about the 2016 ISPE Annual Meeting & Expo will be provided and updated on an on-going basis on ISPE’s website. Check the box next to the sessions you plan to attend. (Note: you have the option to change or add to your registration selections at a later date. Also, if you change your mind later, you may attend different sessions on site than the ones you choose below.) SUNDAY, 18 SEPTEMBER 2016 12:00 – 13:30 Track: Facilities and Equipment __ SES125 How to Get to Know Critical Utilities in 30 Days Track: Regulatory Compliance and Quality Systems __ SES201 Process Capability: Part 1 Track: Product Development and Production Systems __ SES301 Real Life Benefits from Process Closure __ SES403 Big Data in Clinical Research – A Risk-Based Perspective Track: End-to-End Supply Chain Management __ SES503 Metrics for the Clinical Trial Material Supply Chain Track: Innovation Forum __ SES603 Facilities Design & Management and Flexible Manufacturing: Part 1 13:45 – 15:15 Track: Facilities and Equipment __ __ __ SES109 Site Master and Investment Planning SES110 The Ins and Outs of Critical Systems Sampling SES111 FOYA Session #1 Track: Regulatory Compliance and Quality Systems __ SES204 Demystifying the Knowledge Management Enabler of ICH Q10 Track: Women in Pharma __ SES701 Women in Pharma: Part 2 Track: Product Development and Production Systems __ SES304 OSD Continuous Manufacturing – PAT Track: Regulatory Compliance and Quality Systems __ SES208 Drug Shortages Track: Information Systems Track: Product Development and Production Systems __ __ SES404 Critical Thinking and Data Integrity Track: End-to-End Supply Chain Management __ SES504 Patient-Focused Drug Development Program and Patient Testimonial SES308 Aseptic Technology and GMP Quality Systems for Compounding Industry Track: Information Systems __ SES407 Inspecting for Data Integrity Track: Innovation Forum Track: End-to-End Supply Chain Management __ __ SES604 Facilities Design & Management and Flexible Manufacturing: Part 2 SES507 Building a Harmonized Serialization Information Architecture Track: Innovation Forum 16:15 – 17:45 Track: Facilities and Equipment __ __ __ __ SES112 GMP Clinical Facilities – The Intersection of the University and Pharma SES113 Energy and Water Sustainability in Your Facility SES114 Cross Contamination Workshop SES115 FOYA Session #2 __ WEDNESDAY, 21 SEPTEMBER 2016 8:30 – 10:00 Track: Facilities and Equipment __ __ Track: Regulatory Compliance and Quality Systems __ SES205 Recent Regulatory Compliance Developments in China SES305 Real-Time Release Testing – How IT Systems Support the Process Control Strategy SES121 "Dancing Through Traffic" – Project Execution in Operating Plants SES122 Off-Site Construction Delivery Method for a Pharmaceutical Manufacturing Facility Expansion Track: Product Development and Production Systems __ Track: Product Development and Production Systems __ SES607 Supply Chain Integrity __ SES307 Injection-Pens, Autoinjectors, and Combination Products SES309 Flexible Continuous Processing Retrofit Track: Information Systems Track: Information Systems __ __ Track: End-to-End Supply Chain Management SES405 A Holistic Approach to Data Integrity Track: End-to-End Supply Chain Management __ SES505 Social Networks and the Impact on Clinical Trials Track: Innovation Forum __ __ __ Track: Innovation Forum __ SES608 Sustainable/Green Manufacturing SES101 Building Information Modelling – Enabler for Project Team Collaboration and Lean Projects SES116 Rouging in Pharmaceutical Production: Part 2 SES117 OSD Manufacturing Facilities of the Future 10:15 – 11:45 Track: Facilities and Equipment __ __ SES207 Process Validation SES123 GMP or non-GMP Washers-Sterilizers? How to Choose? SES124 Innovating Project Management – Focus on Biopharmaceutical Drug Delivery Track: Regulatory Compliance and Quality Systems __ Track: Regulatory Compliance and Quality Systems __ SES508 Supply Chain Transformation and Innovative Information Technology SES605 Control Strategy TUESDAY, 20 SEPTEMBER 2016 11:00 – 12:30 Track: Facilities and Equipment __ __ SES408 Auditing Cloud Providers SES210 Quality Metrics – Advancing Our Collective Vision Track: Product Development and Production Systems Track: Product Development and Production Systems __ __ Track: Information Systems SES306 Production of Orphan Drugs SES310 Engineering Solutions for OSD Track: Information Systems __ __ Track: End-to-End Supply Chain Management SES406 Track & Trace/Serialization: Part 1 Track: End-to-End Supply Chain Management __ SES506 Best Practices in Operations and Supply Chain Management Track: Innovation Forum __ SES606 Risk Management and Quality 13:45 – 15:15 Track: Facilities and Equipment __ __ __ __ SES105 New Directions in Biotech Facility Design SES118 Applying Condition-Based Maintenance to Reduce & Optimize Plant Shutdowns SES119 Next-Generation Biomanufacturing SES120 Practical Application of Risk-Based Commissioning and Qualification __ SES409 Track & Trace/Serialization: Part 2 SES509 Regulations and CoP Updates