34th SQA Annual Meeting ?· 34th SQA Annual Meeting and Quality College! The SQA Annual Meeting will…

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    34th SQA Annual Meeting

    Registration Brochurewww.sqa.org/SQA2018

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    The Wonderful World of Quality

    Annual Meeting VenueAnaheim Marriott700 W. Convention WayAnaheim, CA 92802 USA

    Tel: +1.714.750.8000Fax: +1.714.750.9100

    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.

    SQA Annual Meeting Group Rate: $209 per night

    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!

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    Annual Meeting VenueAnaheim Marriott700 W. Convention WayAnaheim, CA 92802 USA

    Tel: +1.714.750.8000Fax: +1.714.750.9100

    Annual Meeting ScheduleSunday, 8 April 20188:00 AM - 5:00 PM Quality College Training Monday, 9 April 20188:00 AM - 5:00 PM Quality College Training 5:30 PM - 7:30 PM Opening Reception (Complimentary to full Annual Meeting registrants)

    Tuesday, 10 April 20187:30 AM - 5:00 PM Registration7:15 AM - 8:15 AM Networking with Exhibitors7:15 AM - 3:30 PM Exhibits/Posters Open8:15 AM - 10:00 AM Opening Plenary10:00 AM - 10:30 AM Networking Beverage Break with Exhibitors10:30 AM - 5:00 PM Concurrent Sessions12:00 PM - 1:30 PM Networking Lunch with Exhibitors3:00 PM - 3:30 PM Networking Beverage Break with Exhibitors5:00 PM - 6:30 PM SQA Committee/Specialty Section/Chapter Meetings

    Wednesday, 11 April 20187:30 AM - 5:00 PM Registration7:30 AM - 8:30 AM Networking with Exhibitors7:30 AM - 3:30 PM Exhibits/Posters Open8:30 AM - 5:00 PM Concurrent Sessions10:00 AM - 10:30 AM Networking Beverage Break with Exhibitors12:00 PM - 1:30 PM Networking Lunch with Exhibitors3:00 PM - 3:30 PM Networking Beverage Break with Exhibitors5:00 PM - 6:00 PM SQA Committee/Specialty Section/Chapter Meetings7:00 PM - 10:00 PM House of Blues Dinner (tickets required) Thursday, 12 April 20187:30 AM - 5:00 PM Registration7:30 AM - 8:30 AM Annual Business Meeting8:30 AM - 10:00 AM Concurrent Sessions10:00 AM - 10:30 AM Networking Beverage Break10:30 AM - 12:00 PM Closing Plenary12:00 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 20188:00 AM - 5:00 PM Quality College Training

    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.

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    Online registration is available via www.sqa.org/SQA2018A 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 PolicyRefund 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 RefundThrough 12 February 2018 Full, less $5513 February 9 March 2018 75%, less $5510 March 26 March 2018 50%, less $5527 March 2018 and later None

    Substitution PolicyIf 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 PolicyIf 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 ChangesPlease 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 PolicyRemittance 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 MemberRegistrants 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.

    Registration Information

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    Registration Form

    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 +1 434.977.1856or mail to SQA HQ; 154 Hansen Rd., Suite 201; Charlottesville, VA 22911 USA

    Name: Mr. Ms. Dr.

    ___________________________________________________________________________________________________________(First/Given) (Middle) (Last/Surname) (Suffi x) (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 GMPAre you interested in being an SQA Ammbassador? Yes Area of Expertise: GCP GLP GMPThe 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 2018Annual 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 t icket to Opening Recept ion)

    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.

    SPEAKER D ISCOUNT (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 T ICKETSOpening 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: $____________________

    *Must be an SQA Student Member to receive the

    Student Rate.

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    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 RegularSUNDAY, 8 APRIL 20181 - GLP 101: Basic Training (2 days) 2 - GCP 101: Understanding the Basics (2 days) 3 - CAPA 101: Problem Defi nition - 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) 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 201813 - 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 Cs of SOPs(half day, afternoon) 17 - General 105: Bias Control (half day, afternoon)

    FRIDAY, 13 APRIL 201818 - 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: Auditors 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)

    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: __________________________________________________________________________________________________ *Note: Receipts for all transactions will be sent to the registrant via email.

    $745 $805 $895 $955 $375 $405 $745 $805 $895 $955 $375 $405 $510 $570 $660 $720...

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