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1 S Annual Meeting 1 3 & Quality College st TM TM Tampa A pril5 e 201 c n avigating the S mplia FLORIDA N eas of Co 2015 Registration Brochure -1- USA

2 Navigating the Seas of Compliance The Society of Quality Assurance invites you to Tampa, Florida for the 31st SQA Annual Meeting! The SQA Annual Meeting will include training and concurrent sessions dedicated to promoting and advancing the principles and knowledge of quality assurance essential to human, animal and environmental health worldwide. SQA will present a program of interest to QA professionals, management, study personnel and regulatory authorities around the world. Sessions will focus on regulatory-based topics in clinical (GCP) and preclinical (GLP) research and manufacturing (GMP) arenas. Other areas of interest represented include animal health, bioanalysis, biotechnology, computer validation, medical devices, scientific archiving, university issues and much more. -2-

3 31st SQA Annual Meeting The 31st SQA Annual Meeting and Quality College will include training and concurrent sessions dedicated to promoting and advancing the principles and knowledge of quality assurance essential to human, animal and environmental health worldwide. Quality College training workshops will be offered Sunday Monday, April 2015, and Friday, 17 April 2015, consisting of two-day, full-day and half-day courses. The Annual Meeting will be held Tuesday Thursday, April Three days of plenary and concurrent sessions will explore hot topics and the latest regulatory interpretations in the field. Abstracts for sessions were solicited via a well-promoted online abstract submission service to ensure a program of interest to QA professionals, management, study personnel and regulatory authorities around the world. Who Should Attend Professionals who promote and advance the principles and knowledge of quality assurance essential to human, animal and environmental health worldwide. Session Composition The SQA Program Committee and Specialty Section volunteers review the abstracts and place them into the program by topic. Quality College workshops are developed by the SQA Education Committee, and subject experts are invited to give presentations during these workshops. SQA Membership 2015 membership in the Society of Quality Assurance affords attendees reduced registration fees for the 31st SQA Annual Meeting and Quality College. SQA is an international professional membership organization dedicated to promoting and advancing the principles and knowledge of quality assurance essential to human, animal and environmental health. If you would like to take advantage of the membersonly discount, please complete a membership application and submit payment for dues with your Annual Meeting Registration Form. Please include required documentation if applying for Active membership. Apply for membership online or download an application at

4 Hotel and Venue Information Reservations by attendees must be received on or before Friday, 20 March Reservatiuons Toll Free: Check-in: 4:00 PM Check-out: 12:00 PM Staffed Business Center Valet parking fee: $24 daily Short Term Valet (day time only): $13 SQA group rates are extended three days prior to and three days following the dates of the Annual Meeting on a space-available basis. SQA cannot guarantee the group rate for reservations made after 20 March A valid credit card is required to hold your reservation. This credit card will be charged one night s room rate and tax if your reservation is cancelled within 24 hours prior to arrival. Individuals may cancel up to 24 hours prior to arrival with no penalty. Visit for online reservation information. In order to receive the special group discounted rate, you must specify that you are with the SQA Annual Meeting. Travel Conference Venue Tampa Convention Center 333 South Franklin Street Tampa, FL Tel: Hotel Tampa Marriott Waterside 700 South Florida Avenue Tampa, FL Tel: Tampa International Airport (TPA) Distance to hotel: approximately 9 miles Estimated taxi fare: approximately $25 (one way) St. Petersburg-Clearwater International Airport (PIE) Distance to hotel: approximately 22 miles Estimated taxi fare: approximately $45 (one way) Group Rates for the 31st SQA Annual Meeting Single/Double: $ (plus 12% tax) Wireless internet available in guest rooms for $1.00/day (special rate) Reserve your room online at the special group rate via the link at It s just a short walk across the street from the Tampa Marriott Waterside Hotel and Marina to the Tampa Convention Center

5 Registration Information Online registration is available via A hard copy registration form is on pages 9 and 10. All Annual Meeting registration fees include plenary and concurrent sessions, the Program Book and all scheduled continental breakfasts, lunches and breaks as outlined in the program. Important Payment Note: The registration form must be accompanied by your credit card information or check in full payment of registration fees and events. All non-u.s. members will be charged the U.S. dollar equivalent at the time the charge is processed, unless otherwise indicated. To qualify for early registration rates, this form must be faxed or postmarked by 9 March Cancellation Refund Policy Refund requests must be made in writing to SQA Headquarters. Refunds of Annual Meeting and/ or Quality College registration fees, minus a $55 processing charge, are made on the following schedule: Date of Cancellation Refund Through 9 February 2015 Full, less $55 10 February 9 March %, less $55 10 March 30 March %, less $55 31 March 2014 and later None Substitution Policy If you become unable to attend the Quality College or Annual Meeting, you may send a substitute in your place. Each registration substitution will be charged a $55 processing fee. Quality College Course Change Policy If you have registered for a Quality College course and would like to attend a different course, you may change your registration. Each course change is subject to availability and will be charged any applicable difference in price plus a $55 processing fee. Returned Check Policy Remittance must be made in U.S. dollars. A surcharge may be assessed to cover any collection fees. Emergency Illness or Death of Registrant or Immediate Family Member Registrants who are unable to attend the Quality College or Annual Meeting because of a serious illness or death may receive a partial refund (amount paid minus the $55 processing fee) or full credit for a future meeting (as applicable) in the following instances: Personal illness or death of the attendee; or Illness or death in the immediate family of the attendee. Requestors shall submit the request in writing to SQA Headquarters along with written documentation from a doctor. The Program Chair shall review the request to ensure it is in accordance with written policy

6 Annual Meeting Schedule Sunday, 12 April :00 a.m. - 5:00 p.m. Quality College Training Monday, 13 April :00 a.m. - 5:00 p.m. Quality College Training 5:30 p.m. - 8:30 p.m. Opening Reception (Complimentary to 3-day Annual Meeting registrants) Tuesday, 14 April :30 a.m. - 5:00 p.m. Registration 7:30 a.m. - 8:30 a.m. Networking/Continental Breakfast with Exhibitors 7:30 a.m. - 3:30 p.m. Exhibits/Posters Open 8:30 a.m. - 10:00 a.m. Opening Plenary 10:00 a.m. - 10:30 a.m. Networking/Beverage Break with Exhibitors 10:30 a.m. - 5:00 p.m. Concurrent Sessions 12:00 p.m. - 1:30 p.m. Networking/Lunch with Exhibitors 3:00 p.m. - 3:30 p.m. Networking/Beverage and Snack Break with Exhibitors 5:00 p.m. - 6:30 p.m. SQA Committee/Specialty Section Meetings 6:30 p.m. - 8:00 p.m. SQA International Networking Reception Wednesday, 15 April :30 a.m. - 5:00 p.m. Registration 7:30 a.m. - 8:30 a.m. Networking/Continental Breakfast with Exhibitors 7:30 a.m. - 3:30 p.m. Exhibits/Posters Open 8:30 a.m. - 5:00 p.m. Concurrent Sessions 10:00 a.m. - 10:30 a.m. Networking/Beverage Break with Exhibitors 12:00 p.m. - 1:30 p.m. Networking/Lunch with Exhibitors 3:00 p.m. - 3:30 p.m. Networking/Beverage and Snack Break with Exhibitors 3:30 p.m. Exhibitor Teardown 5:00 p.m. - 6:00 p.m. SQA Committee/Specialty Section Meetings 6:30 p.m. - 9:00 p.m. Dinner at Tampa s Lowry Park Zoo (tickets required) Thursday, 16 April :30 a.m. - 3:30 p.m. Registration 7:30 a.m. - 8:30 a.m. Continental Breakfast and Annual Business Meeting 8:30 a.m. - 10:00 a.m. Concurrent Sessions 10:00 a.m. - 10:30 a.m. Networking/Beverage Break 12:00 p.m. - 1:00 p.m. Networking/Lunch 10:30 a.m. - 3:30 p.m. Regulatory Updates and Panel Friday, 17 April :00 a.m. - 5:00 p.m. Quality College Training - 6 -

7 Quality College Courses Sunday, 12 April Basic Training: Good Laboratory Practice (2 days, Sunday and Monday) 2 Good Clinical Practice: The Basics (2 days, Sunday and Monday) 3 Basic Concepts in Computer Validation (2 days, Sunday and Monday) 4 Problem Definition Through Root Cause Analysis: Moving Beyond Human Error (full day) 5 Archiving 101: What You Need to Know About GLP-Compliant Archives (half day, morning) 6 Electronic Archiving and Digital Decay (half day, afternoon) 7 History Behind the FDA GLPs and Their Application (half day, morning) 8 OECD GLP (half day, afternoon) 9 What Does Quality Cost? (half day, morning) 10 QA Consulting 101 (half day, morning) 11 SQA Leadership Development (half day, afternoon) Monday, 13 April Basic Training: Good Laboratory Practice (continued from Sunday) 2 Good Clinical Practice: The Basics (continued from Sunday) 3 Basic Concepts in Computer Validation (continued from Sunday) 12 CAPA Development, Implementation, and Confirmation of Success (full day) 13 GLPs: Beyond the Basics (full day) 14 QA Professional Fundamentals 101 (full day) 15 New Perspectives in QA: Tools, Techniques and Strategies for Enhancing Effectiveness and Enjoyment (full day) 16 Archiving 201: Beyond a GLP-Compliant Archiving Function (half day, morning) 17 Lessons Learned While Embarking into Electronic Data Collection (EDC) in Clinical and Non-Clinical Veterinary Studies (half day, afternoon) Friday, 17 April GCP Beyond the Basics: Best Practices in Vendor Management (full day) 19 Pharmacovigilance Auditing: European GVP Legislation (full day) 20 Good Practices: Understanding the GxP Regulations Using a Quality System Approach (full day) 21 Risk-Based GCP Auditing (full day) 22 Auditing Software and Data Providers with a Focus on Cloud Services (half day, morning) Please visit the Quality College website at for course descriptions and details. Daily Training Schedule 7:00 am - 5:00 pm Registration 7:00 am - 8:00 am Networking/Continental breakfast 8:00 am - 10:00 am Instruction 10:00 am - 10:15 am Networking/Beverage break 10:15 am - 12:00 pm Instruction, continued 12:00 pm - 1:00 pm Networking/Lunch buffet 1:00 pm - 3:00 pm Instruction, continued 3:00 pm - 3:15 pm Networking/Beverage & snack break 3:15 pm - 5:00 pm Instruction, continued - 7 -

8 Special Events, Area Attractions, and Post Conference Activities Dinner at Tampa s Lowry Park Zoo Wednesday, 15 April :30-10:00 PM Tickets are $100 per person SQA invites you to join us for dinner at Tampa s Lowry Park Zoo. Enjoy the Zoo in the evening with drinks by the giraffe habitat and dinner in the Safari Lodge. Quality in Paradise Cruise Thinking about a mini vacation after the SQA conference? Check out the 5 days of fun on the Quality in Paradise Cruise being offered by Custom Quests Travel! The cruise ship departs from Tampa on Saturday, April 18th and returns on Thursday, April 23rd, For further details and to make a reservation, please visit the following link: mybookinggenie.com/quality-in-paradise-cruise. Area Attractions Busch Gardens Tampa - Busch Gardens, a place that celebrates wild lands and the world we share with one of the largest zoological facilities in the country, along with top-ranked roller coasters, Broadway-style shows and world class family entertainment. Busch Gardens Tampa offers discount tickets to conference attendees, please click on the below link to purchase tickets in advance. Ybor City - Enjoy Historic Ybor City s exotic blend of sights and sounds, with a rich history to explore during the day and a sizzling nightlife to experience after sundown. The district s vibrant community embraces its past to create a culture that is uniquely Ybor City. Sanibal - Sanibel Island is an average of 2 and a half hours driving time from Tampa Bay. Sanibel Island is world renowned for treasures from the sea pastel colored seashells that pile up on the beaches, a shell seekers delight. Sanibel Island is home to the world famous J.N. Ding Darling National Wildlife Refuge that encompasses a large portion of the island. Sanibel Island has an abundance of sunshine, all year round, miles of meandering bike paths, sugary white sand beaches with Caribbean blue seas

9 T M T M 31 st S Annual Meeting & Quality Colleg e Navigat ing the Seas A pril 2015 Tampa FLORIDA USA of Comp lianc e Name: Mr. Ms. Dr. (First/Given) (Middle) (Last/Surname) (Suffix) Badge Name: (First Name or Nickname) Title: Organization: Address: City and State: ZIP/Postal Code: Country: Phone: SQA Member Nonmember Annual Meeting Speaker Quality College Speaker First Time Attendee Special Meal Requests: Vegetarian Meals Vegan Meals Kosher Meals Allergy Emergency Contact: Phone: How did you hear about the meeting? Registrants outside the U.S. Please list any national QA society of which you are a member: ANNUAL MEETING REGISTRATION FEES Member Rates* Nonmember Rates Early Regular Early Regular by 9 March after 9 March by 9 March after 9 March FULL MEETING, TUE - THUR, APRIL 2015 Annual Meeting (includes all concurrent sessions) $685 $790 $940 $1045 Opening Reception - Please check if you plan to attend (Mon, 13 April 2015, 5:30-8:30 pm) 1 Complimentary Ticket See below for GUEST tickets. ONE DAY ONLY REGISTRATION OPTIONS (does not include ticket to Opening Reception) Tuesday, 14 April 2015, Only or $300 $350 $380 $430 Wednesday, 15 April 2015, Only or $300 $350 $380 $430 Thursday, 16 April 2015, Only $300 $350 $380 $430 Opening Reception (Monday, 13 April 2015) $50 Separate ticket purchase required for One Day Only Registrant. See below for GUEST tickets. SPEAKER DISCOUNT (Applies only to Quality College and Annual Meeting concurrent session presenters) Speaker Discount for 3-day Annual Meeting Registration -$100 Speaker Discount for One Day Only Registration -$ 50 SPECIAL EVENT TICKETS Opening Reception GUEST Tickets for non-registrants who will come with you to the reception Monday, 13 April 2015, 5:30-8:30 pm $50 each No. $ Dinner at Tampa s Lowry Park Zoo Registration Form Wednesday, 15 April 2015, 6:30-10: 00 pm, $100 each No. $ SUBTOTAL MEETING AND EVENT FEES: $ Please make sure to enter the subtotal on this page and copy it to the next page. Please make sure your name is on both pages. This assures that we can match the pages, just in case they should become separated. to sqa@sqa.org or fax BOTH PAGES of the form to or mail to SQA HQ; 154 Hansen Rd., - Suite 9-201; Charlottesville, VA USA Please DO NOT credit card information.

10 T M T M 31 st S Annual Meeting & Quality Colleg e Navigat ing the Seas A pril 2015 Tampa FLORIDA USA of Comp lianc e Registration Form Name: (First) (Middle) (Last) SUBTOTAL MEETING AND EVENT FEES FROM PREVIOUS PAGE: $ PRECONFERENCE QUALITY COLLEGE Rates: Member* Nonmember Early Regular Early Regular SUNDAY, 12 APRIL Basic Training: Good Laboratory Practice (2 days) $745 $805 $895 $ Good Clinical Practice: The Basics (2 days) $745 $805 $895 $ Basic Concepts in Computer Validation (2 days) $745 $805 $895 $ Problem Definition Through Root Cause Analysis (full day) $510 $570 $660 $ Archiving 101 (half day, morning) $285 $345 $385 $ Electronic Archiving and Digital Decay (half day, afternoon) $285 $345 $385 $ History Behind the FDA GLPs and Their Application (half day, morning) $285 $345 $385 $ OECD GLP (half day, afternoon) $285 $345 $385 $ What Does Quality Cost? (half day, morning) $285 $345 $385 $ QA Consulting 101 (half day, morning) $285 $345 $385 $ SQA Leadership Development (half day, afternoon) For SQA Members Only Complimentary MONDAY, 13 APRIL Basic Training: Good Laboratory Practice Continued from Sunday - no further charge 2 - Good Clinical Practice: The Basics Continued from Sunday - no further charge 3 - Basic Concepts in Computer Validation Continued from Sunday - no further charge 12 - CAPA Development, Implementation, and Confirmation of Success (full day) $510 $570 $660 $ GLPs: Beyond the Basics (full day) $510 $570 $660 $ QA Professional Fundamentals 101 (full day) $510 $570 $660 $ New Perspectives in QA (full day) $510 $570 $660 $ Archiving 201 (half day, morning) $285 $345 $385 $ Lessons Learned While Embarking into EDC (half day, afternoon) $285 $345 $385 $445 POSTCONFERENCE QUALITY COLLEGE FRIDAY, 17 APRIL GCP Beyond the Basics: Best Practices in Vendor Management (full day) $510 $570 $660 $ Pharmacovigilance Auditing: European GVP Legislation (full day) $510 $570 $660 $ Good Practices: Understanding the GxP Regulations (full day) $510 $570 $660 $ Risk-Based GCP Auditing (full day) $510 $570 $660 $ Auditing Software and Data Providers (half day, morning) $285 $345 $385 $445 TOTAL ANNUAL MEETING, EVENT AND QUALITY COLLEGE FEES: $ METHOD OF PAYMENT (PLEASE CHECK ONE): MasterCard VISA American Express Check #: (Checks should be made payable to the Society of Quality Assurance) by 9 March after 9 March by 9 March after 9 March Card Number: Expiration Date: Security code: (3 digits on back of card or 4 digits on front of AmEx) Cardholder Printed Name: Signature: *Note: Receipts for all transactions will be sent to the registrant via