34th SQA Annual Meeting

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34th SQA Annual Meeting Registration Brochure www.sqa.org/sqa2018-1 -

The Wonderful World of Quality The Society of Quality Assurance invites you to Anaheim, California for the 34th SQA Annual Meeting and Quality College! 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, pharmacovigilance, scientific archiving, university issues and much more. Who are SQA members and colleagues? The professionals in this Society are challenged to perform duties relating to quality assurance of nonclinical laboratory studies within the scope of the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) Good Laboratory Practice (GLP) regulations; and international standard for nonclinical laboratory studies prepared by the Organization for Economic Cooperation and Development; clinical investigations within the scope of FDA Good Clinical Practice regulations, EPA regulations for the Protection of Human Subjects, United States Department of Agriculture regulations for veterinary biologics; and international standards for clinical investigations prepared by the International Conference on Harmonization (ICH) and the Veterinary International Conference on Harmonization (VICH); and FDA current Good Manufacturing Practice regulations and the international quality standards prepared by the ICH and VICH. The Society of Quality Assurance invites you Anaheim, California for the 34th SQA Annual Meeting. In your leisure time, enjoy Disneyland, Huntington Beach, LA Angels baseball games, fine dining, shopping and much more! Annual Meeting Venue Anaheim Marriott 700 W. Convention Way Anaheim, CA 92802 USA Tel: +1.714.750.8000 Fax: +1.714.750.9100 SQA Annual Meeting Group Rate: $209 per night - 2 -

Annual Meeting Schedule Sunday, 8 April 2018 8:00 AM - 5:00 PM Quality College Training Monday, 9 April 2018 8:00 AM - 5:00 PM Quality College Training 5:30 PM - 7:30 PM Opening Reception (Complimentary to full Annual Meeting registrants) Tuesday, 10 April 2018 7:30 AM - 5:00 PM Registration 7:15 AM - 8:15 AM Networking with Exhibitors 7:15 AM - 3:30 PM Exhibits/Posters Open 8:15 AM - 10:00 AM Opening Plenary 10:00 AM - 10:30 AM Networking Beverage Break with Exhibitors 10:30 AM - 5:00 PM Concurrent Sessions 12:00 PM - 1:30 PM Networking Lunch with Exhibitors 3:00 PM - 3:30 PM Networking Beverage Break with Exhibitors 5:00 PM - 6:30 PM SQA Committee/Specialty Section/Chapter Meetings Wednesday, 11 April 2018 7:30 AM - 5:00 PM Registration 7:30 AM - 8:30 AM Networking with Exhibitors 7:30 AM - 3:30 PM Exhibits/Posters Open 8:30 AM - 5:00 PM Concurrent Sessions 10:00 AM - 10:30 AM Networking Beverage Break with Exhibitors 12:00 PM - 1:30 PM Networking Lunch with Exhibitors 3:00 PM - 3:30 PM Networking Beverage Break with Exhibitors 5:00 PM - 6:00 PM SQA Committee/Specialty Section/Chapter Meetings 7:00 PM - 10:00 PM House of Blues Dinner (tickets required) Special Event House of Blues Dinner Cost: $100 per person Join your colleagues for an evening of good food, great drinks and plenty of entertainment at the House of Blues. A buffet dinner with complimentary beer, wine, and soda are included (from 7-9 PM) along with a live band and karaoke. Thursday, 12 April 2018 7:30 AM - 5:00 PM Registration 7:30 AM - 8:30 AM Annual Business Meeting 8:30 AM - 10:00 AM Concurrent Sessions 10:00 AM - 10:30 AM Networking Beverage Break 10:30 AM - 12:00 PM Closing Plenary 12:00 PM - 1:00 PM Networking Lunch (tickets required unless attending Thursday afternoon training) 1:30 PM - 5:30 PM Quality College Training Friday, 13 April 2018 8:00 AM - 5:00 PM Quality College Training - 3 -

Registration Information Online registration is available via www.sqa.org/sqa2018 A hard copy registration form is on pages 5 and 6. All Annual Meeting registration fees include plenary and concurrent sessions, the Program Book and all scheduled 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 2018. 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 12 February 2018 Full, less $55 13 February 9 March 2018 75%, less $55 10 March 26 March 2018 50%, less $55 27 March 2018 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. Disclaimer - Program/Speaker Changes Please understand that there may be changes to the program as situations occur for presenters leading up to the meeting, and that presenters for workshops and the Annual Meeting are subject to change. SQA will keep you informed of any changes as they occur, and we reserve the right to substitute speakers to complete workshops or sessions or to make presentations where other presenters have had to cancel or reschedule their presentations dates and/or times. As professionals in this field, SQA sincerely appreciates your understanding of this possibility. 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 Co-Chairs shall review the request to ensure it is in accordance with written policy. - 4 -

Registration Form Name: Mr. Ms. Dr. (First/Given) (Middle) (Last/Surname) (Suffix) (Credentials) Badge Name: (First Name or Nickname) Title: Organization: Address: City and State: ZIP/Postal Code: Country: Phone: E-mail: SQA Member Student Member Nonmember Annual Meeting Speaker Quality College Speaker Special Meal Requests: Vegetarian Meals Vegan Meals Kosher Meals Allergy Emergency Contact: Phone: How did you hear about the meeting? Registrant outside the U.S. Please list any national QA society of which you are a member: Would you like to be assigned an SQA Ammbassador? Yes Area of Expertise: GCP GLP GMP Are you interested in being an SQA Ammbassador? Yes Area of Expertise: GCP GLP GMP The Ambassador Pogram helps new attendees navigate the meeting, select sessions, and network within SQA. ANNUAL MEETING REGISTRATION FEES Member Rates Nonmember Rates Student Rates* Early Regular Early Regular Early Regular by 9 Mar. after 9 Mar. by 9 Mar. after 9 Mar. by 9 Mar. after 9 Mar. FULL MEETING, TUE - THUR, 10-12 APRIL 2018 Annual Meeting (includes all concurrent sessions) $695 $800 $950 $1055 $350 $400 Opening Reception - Please check if you plan to attend (Mon, 9 April 2018, 5:30-7:30 pm) 1 Complimentary Ticket ONE DAY ONLY REGISTRATION OPTIONS (does not include ticket to Opening Reception) Tuesday, 10 April 2018, Only or $305 $355 $385 $435 $155 $180 Wednesday, 11 April 2018, Only or $305 $355 $385 $435 $155 $180 Thursday, 12 April 2018, Only $185 $235 $215 $265 $95 $120 Opening Reception - One Day Only Registrant (Monday, 9 April 2018) $50 Separate ticket purchase required for One Day Only Registrant. See below for GUEST tickets. *Must be an SQA Student Member to receive the Student Rate. SPEAKER DISCOUNT (Applies only to Quality College and Annual Meeting concurrent session presenters) Speaker Discount for full Annual Meeting Registration -$100 Speaker Discount for One Day Only Registration -$ 50 THURSDAY LUNCH (do not select if attending Thursday afternoon workshop) Lunch on Thursday for those NOT attending Thursday afternoon workshops $35 $ SPECIAL EVENT TICKETS Opening Reception GUEST Tickets for non-registrants who will come with you to the reception Monday, 9 April 2018, 5:30-7:30 pm $50 each No. $ House of Blues Dinner - Buffet dinner including beer and wine for 2 hours (7:00-9 :00 PM) Wednesday, 11 April 2018, 7:00-10:00 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. Email to sqa@sqa.org or fax BOTH PAGES of the form to +1 434.977.1856 or mail to SQA HQ; 154 Hansen Rd., Suite 201; Charlottesville, VA 22911 USA - 5 -

Registration Form Name: (First) (Middle) (Last) SUBTOTAL MEETING AND EVENT FEES FROM PREVIOUS PAGE: $ PRECONFERENCE QUALITY COLLEGE Rates: Member Nonmember Student Member* Early Regular Early Regular Early Regular SUNDAY, 8 APRIL 2018 1 - GLP 101: Basic Training (2 days) 2 - GCP 101: Understanding the Basics (2 days) 3 - CAPA 101: Problem Definition - Beyond Human Error (full day) 4 - CSV 101: Basic Concepts in Computer Validation (2 days) 5 - GMP 101: History and Introduction of the US FDA GMPs (full day) 6 - GCP 301: Audits in Biostatistics (full day) $745 $805 $895 $955 $375 $405 $745 $805 $895 $955 $375 $405 $745 $805 $895 $955 $375 $405 MONDAY, 9 APRIL 2018 1 - GLP 101: Basic Training 2 - GCP 101: Understanding the Basics 4 - CSV 101: Basic Concepts in Computer Validation 7 - CAPA 201: Creation and Effectiveness (full day) Course 3 (CAPA 101) is a prerequisite to attend course 7. 8 - GLP 103: Basic GLP Archiving (half day, morning) 9 - GCP 202: Hot Topics and Industry Trends (full day) 10 - GLP 301: Metrics and You: Perfect Together (half day, morning) 11 - GLP 203: Intermediate GLP Archving (half day, afternoon) 12 - General 102: SQA Leadership Training (half day, afternoon) POSTCONFERENCE QUALITY COLLEGE THURSDAY, 12 APRIL 2018 13 - GLP 202: Regulatory Surveillance Inspections (half day, afternoon) 14 - General 103: The Biologics Super Highway (half day, afternoon) 15 - General 101: QA Consulting (half day, afternoon) 16 - General 104: Three C s of SOPs(half day, afternoon) 17 - General 105: Bias Control (half day, afternoon) FRIDAY, 13 APRIL 2018 18 - GCP 201: Advanced Training (full day) 19 - CSV 203: Auditing in the GxP edata Space (full day) 20 - General 201: Systems Thinking in Quality Management (full day) 21 - General 106: Auditor s Primer on Chromatography (full day) 22 - GLP 102: History Behind the FDA GLPs (half day, morning) 23 - CSV 204: SEND- Implementation & Validation (half day, morning) Continued from Sunday - no further charge Continued from Sunday - no further charge Continued from Sunday - no further charge For SQA Members Only - Complimentary *Must be an SQA Student Member to receive the Student Rate. 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) Card Number: Expiration Date: Security code: (3 digits on back of card or 4 digits on front of AmEx) Cardholder Printed Name: Signature: - 6 - *Note: Receipts for all transactions will be sent to the registrant via email.