28th SQA Annual Meeting and Quality College

Sunday - Friday, 22 - 27 April 2012

Miami Hyatt Regency

Miami, Florida, USA

REGISTER ONLINE NOW

View the hard copy registration brochure.

Register on or before 26 March 2012 to receive reduced rates. 

Book your hotel rooms on or before 30 March 2012 to guarantee the special group rate. See the HOTEL TAB above. 

Quality College will be held Sunday - Monday, 22 - 23 April 2012 and
Friday, 27 April 2012, consisting of two-day, full-day and half-day workshops.
See the tab above for details. 

The Annual Meeting will be held Tuesday – Thursday, 24 - 26 April 2012.  Three days of plenary and concurrent sessions will explore hot topics and the latest regulatory interpretations in the field.   Sessions will focus on regulatory-based topics in manufacturing (GMPs), preclinical (GLPs) and clinical (GCPs) research arenas.  Other areas of interest include animal health, bioanalysis, biotechnology, computer validation, medical devices, university issues and much more.

April 2012 SQA Quality College

22, 23 and 27 April 2012
Miami, Florida, USA

Join the Society of Quality Assurance Education Committee in Miami, Florida, for three days of events dedicated to networking and education for Quality Assurance professionals!  Each function of this event will count toward fulfilling the requirements of RQAP re-registration.  These courses are being held in conjunction with the 28th SQA Annual Meeting, 24 - 26 April 2012.

REGISTER ONLINE on or before 26 March 2012 to take advantage of reduced early registration fees. Alternatively, use the hard copy registration form.  See the Registration Policies tab above.

Special room rates have been arranged at the Hyatt Regency Miami.  Please see the "Hotel" tab above for details on reserving rooms at the special group rate. The special rate guarantee ends 30 March 2012.

Below is the list of the functions being offered on each day. Click on the course title to view the course description and pricing.

Sunday, 22 April 2012

• 1 - Basic Training: Good Laboratory Practice (TWO DAYS: 8 am - 5 pm Sunday and Monday) 
• 2 - Good Clinical Practice: Understanding the Basics (TWO DAYS: 8 am - 5 pm Sunday and Monday) 
• 3 - Basic Concepts in Computer Validation (TWO DAYS: 8 am - 5 pm Sunday and Monday) 
• 4 - Developing a GLP-Compliant Program in a University Setting(ONE AND ONE HALF DAYS: 8 am - 5 pm Sunday and 8 am - 12 pm Monday) 
• 5 - Train the Trainer: Effective Teaching Strategies (8 am - 5 pm) 
• 6 - Development of Multiple-Choice Questions in GCP and GLP (8 am - 5 pm) 
• 7 - From Lab to Market: Getting Regulatory Approval(8 am - 12 pm) 
• 8 - SQA Leadership Development(1 pm - 5 pm) 

Monday, 23 April 2012 

• 1 - Basic Training: Good Laboratory Practice, continued (TWO DAYS: 8 am - 5 pm Sunday and Monday)  
• 2 - Good Clinical Practice: Understanding the Basics, continued (TWO DAYS: 8 am - 5 pm Sunday and Monday) 
• 3 - Basic Concepts in Computer Validation, continued (TWO DAYS: 8 am - 5 pm Sunday and 8 am - 5 pm Monday) 
• 4 - Developing a GLP-Compliant Program in a University Setting, continued (ONE AND ONE HALF DAYS: 8 am - 5 pm Sunday and 8 am - 12 pm Monday) 
• 9 - Archiving 101: What You Need to Know About GLP-Compliant Archives (1 pm - 5 pm)
• 10 - Current Trends in cGMP (8 am - 5 pm) 
• 11 - Process Mapping to Increase Auditing Quality and Effectiveness (8 am - 5 pm) 
• 12 - Improving the Impact of Quality Assurance: Value-Adding Strategies for the 21st Century (8 am - 5 pm) 

Friday, 27 April 2012

• 13 - Current Topics in Good Laboratory Practice(8 am - 5 pm) 
• 14 - Good Clinical Practice: Beyond the Basics (8 am - 5 pm) 
• 15 - Good Practices: Understanding the GxP Regulations Using a Quality System Approach (8 am - 5 pm) 
• 16 - Common Challenges in Non-Clinical Medical Device Compliance (8 am - 5 pm) 
• 17 - Continual Quality Improvement: Expanding the QA Toolbox (8 am - 5 pm) 
• 18 - GMP for GCP Auditors (8 am - 12 pm) 

Abstract notifications were made in late December.

The SQA Program Committee invited submission on all regulatory QA topics for presentation: manufacturing (GMPs), preclinical (GLPs) and clinical (GCPs). The Committee welcomes abstracts on other areas of interest as well, including animal health, bioanalysis, biotechnology, computer validation, medical devices, scientific archiving, university issues and much more. All presenting authors of abstracts accepted for presentation are required to register for the Annual Meeting and pay the appropriate fees, in accordance with the published fee schedule. Technical abstracts will be published in the Annual Meeting Program Book.

View the Preliminary Program

Abstracts were requested on the following hot topics: 

 updated 4 August 2011 

REGISTER ONLINE NOW

Or use the hard copy registration brochure.

Register on or before 26 March 2012 to receive reduced rates. 

Book your hotel rooms on or before 30 March 2012 to guarantee the special group rate. See the HOTEL TAB above. 

Also see the Registration Policies tab above.

Registration Rates

Members

Through 26 March 2012: $655
After 26 March 2012: $760

Nonmembers

Through 26 March 2012: $910
After 26 March 2012: $1015

One Day Only

Members (before 26 March 2012): $245
Members (after 26 March 2012): $295

Nonmembers (before 26 March 2012): $325
Nonmembers (after 26 March 2012): $375

 Speaker Discounts: 3-day Annual Meeting Registration - $100 discount, One Day Only Registration - $50 discount 

Registration Policies

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.

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:

Substitution Policy

If you become unable to attend Quality College or the Annual Meeting, you may send a substitute in your place.   Each registration substitution will be charged any applicable difference in price plus 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 session, 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

Attendees who are unable to attend the Training or the Conference because of a serious illness or death may receive a partial refund (amount paid minus the $55 processing charge) 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.


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, the hard copy registration form must be faxed or postmarked by 26 March 2012.

Scholarships

Past Presidents’ Scholarship Award - sponsored by the SQA Board of Directors  

The value of the Past Presidents’ Scholarship Award is up to $2,000, which may be used to pay training and registration fees plus travel expenses (documented with receipts) for the SQA Annual Meeting held in the same year that the scholarship is awarded. 

2012 Past Presidents' Scholarship Application Form 

Pamela H. Errico Memorial Scholarship Award - sponsored by MPI Research 

The Pamela H. Errico Memorial Scholarship Award is exclusively available to independent consultants. The value of the award is $2,000, and it may be used to pay training and registration fees plus travel for the SQA Annual Meeting held in the same year that the scholarship is awarded, and any remainder may offset lost revenue occurring by participation in the meeting. 

2012 Pamela H. Errico Memorial Scholarship Application Form 

Outreach Scholarship 

The Outreach Scholarship is sponsored by the SQA Board of Directors for the Annual Meeting. The scholarship shall be provided to a registered Outreach Member and shall include waiver of all training and meeting registration fees, a complimentary ticket for the off-site event and up to 6 nights complimentary hotel room. SQA shall also provide up to $2,000 for travel and meal expense reimbursement (receipts required). Applications shall be accepted every year, but the SQA Board of Directors may decide to defer the scholarship until the next year if the number and/or quality of applications received are deemed insufficient.

2012 Outreach Scholarship Application Form 

If you have any questions regarding these awards, please contact SQA Headquarters.

Independent Consultant Members Table

A unique opportunity meant to highlight the capabilities of QA consultancy businesses run by individual members of SQA.

Consultant Member Table space is open to the independent member consultant who wishes to display marketing materials at the meeting. To take advantage of this opportunity, you must be a current member of SQA and sole proprietor of your consulting business. Registration as an attendee for the meeting is required to participate in this opportunity.

You supply your informational material, and SQA will provide the space and display materials.
 

Consultant Table Space Registration Fee - $55.00

Benefits 

• 18” x 24” Table space in exhibit area to display marketing materials

• Listing as an Individual Consultant Member in the Conference Program, on signage at the meeting, in SQA Newsletters and on the Conference Website, with a link to your consultant homepage.

The cost is low, the impact and visibility are high - do not miss this opportunity to showcase your business to over 700 expected attendees.

To register, please select the Consultant Table function under the Events/Marketing during online event registration, or you may download the  Consultant Members Table Registration Form  to pay via check. 

Exhibit Floorplan 

Register now to be a 2012 Exhibitor. Please download the Exhibitor and Supporter Prospectus for details.

The 2012 SQA Annual Meeting offers the opportunity to market your organization to over 700 expected attendees! Exhibitors are placed in the center of high traffic events that offer great visibility to meeting attendees, such as continental breakfasts, lunches and breaks. 

Exhibit Days: Tuesday, 24 April 2012, 7:30 a.m. – 4:30 p.m. 
Wednesday, 25 April 2012, 7:30 a.m. – 3:30 p.m. 

10’ x 10’ Exhibit Booth - $845.00 (by 28 Jan 12); $900.00 (after 28 Jan 12) 

Exhibit Booths include: 
• 10’ deep x 10’ wide exhibit space 
• Pipe and draping 
• 6’ table and two chairs 
• ID Sign (measures 44” wide x 7” deep) 
• 1 full Annual Meeting registration

Please see exhibitor space agreement to request your complimentary table and chairs. Exhibitors are encouraged to attend their booths, but it is not required at all times. Exhibitors have full privileges for Annual Meeting participation. 


Booth Representative Fees
The Exhibitor fee includes a full Annual Meeting registration for one attendee. Upon receipt of confirmation, you will also receive registration forms for additional booth representatives. The second booth representative fee is $300, and any additional booth representatives will be charged the Annual Meeting registration fee of $655. 


Exhibitor Benefits
All exhibiting companies will receive the following benefits: 
Floor space in exhibit area; 
Listing as an Exhibitor in the Annual Meeting program book; 
Listing as an Exhibitor in the Registration list; 
Listing as an Exhibitor on signage at the Annual Meeting; 
Listing as an Exhibitor in the SQA Newsletter; 
Listing as an Exhibitor on the Annual Meeting website, with a link to your corporate homepage; 
Meeting materials, including the Annual Meeting program book and gifts (1 set per booth); 
Electronic copy of the final Registration list (one-time use); 
Admission to plenary and concurrent sessions, Opening Reception, meals and all 
Annual Meeting events. 

Corporate Supporters

Register now to be a 2012 Corporate Supporter.  Please download the  Exhibitor and Supporter Prospectus for details.

General Support Annual Meeting supporters help underwrite some of the meeting expenses in exchange for recognition in the Annual Meeting program book, on signage at the meeting, in SQA Newsletters and on the Annual Meeting website. Diamond, Platinum, Gold, Silver and Bronze Sponsor contribution levels are available. The minimum contribution for sponsors is $500.00.  See the list of Corporate Supporters in 2011  Expert Lunches – $250 per table The lunches during the conference will have a certain number of tables reserved. Each table will have a topic and an expert speaker in that particular field.  For $250 you can sponsor a table and, if applicable, may provide a topic and speaker. Conference Marketing Emails – $1,000 (limit 2 sponsors) Include your banner ad with a link to your website in four email blasts promoting the 28th SQA Annual Meeting. Your ad will be included in messages sent to over 11,000 potential attendees. E-Program – $2,000 (limit to 1 exclusive sponsor) Enhance your presence at the conference by taking your brand mobile. Your banner ad will be linked to your website from the E-Program designed for smartphone users.

Thank You  2012 Corporate Supporters     Platinum  MPI Research    Silver   Xybion Corporation   Biotechnical Services Inc  Pfizer      Bronze   Pacific Rim/West Coast Quality Training Quality Associates, Inc.

Gift Sponsorship

A unique opportunity to provide a gift to all meeting attendees showcasing your company or organization! You are invited to provide a gift displaying your corporate logo to Annual Meeting attendees. These gifts will be included in the meeting carry bag, which includes the program book and other materials distributed to all attendees. Example gifts are pens, highlighters, letter openers, lavaliere badge holders, mints, mini stress balls, calendars, sticky note pads, page flags, magnets, buttons, etc. This service is free, the impact and visibility are high - do not miss this opportunity to showcase your company or organization to over 700 expected attendees!

Program Advertising

Market your company in the official program book of the 28th SQA Annual Meeting. Use this occasion to market your organization with a profile ad, advertise your consulting or training services, or announce job openings in your company to the entire SQA Annual Meeting registrant population. Opportunities exist for multiple size ads at various prices. Visit www.sqa.org/mediakit for advertising rates.

Hyatt Regency Miami 

View Larger Map 

400 South East Second Avenue
Miami, Florida, USA 33131
Tel: +1 305 358 1234 Fax: +1 305 358 0529
www.miamiregency.hyatt.com

Just 10 minutes from the Miami International Airport, 15 minutes from South Beach and two miles from the Port of Miami, the Hyatt Regency Miami is easily accessible to everywhere you want to be. Enjoy easy access to Miami’s best attractions like Mary Brickell Village, the James L. Knight Center, Coral Gables, and the Latin flavor of Little Havana. 

Room Rates

Group rates for the SQA 28th Annual Meeting & Quality College:

Single:  Double: Triple: Quad:	$169 $169 $194 $219

To reserve your room online, click the button above or click here 

To reserve by phone, call Hyatt Regency Miami reservations at (305) 358-1234 or 1-800-233-1234. In order to receive the special group discounted rate, you must specify that you are with the SQA Annual Meeting.

Hotel room rates are subject to applicable state and local taxes (current 13%) in effect at the time of check-out.

• High Speed Internet Access in guest rooms is discounted for SQA attendees at $4.98 per day.

• Check in time is 3:00 pm, and check-out is 12:00 noon.

• 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 30 March 2012.

• 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.

We urge you to make your hotel reservation at our conference hotel in order for SQA to maximize its meeting space and room block and to help keep negotiated room rates as low as possible. The guest room block and group rate negotiated with the hotels includes costs to provide us with the large quantity of meeting space we require for the meeting. If we do not occupy a sufficient amount of guest rooms throughout the conference, we will incur penalties and additional costs. Therefore, we urge all meeting participants to stay in the conference hotel.  

Transportation

To and From Miami International Airport:

Super Shuttle 

Super Shuttle offers 24 hour service to the Hyatt Regency Miami for $18 per person. Attendees should go to the Super Shuttle station located at the Van/Limo booth directly outside of the lower level baggage claim area near curbside pick-up.  Blue vans with yellow lettering say Super Shuttle.

Taxi 

Approximately $20-$25 one-way.

To and From Fort Lauderdale Airport

Super Shuttle 

Super Shuttle does not transport attendees from the airport to the Hyatt Regency  but does provide transportation from the Hyatt Regency to the airport for approximately $32 per person.

Taxi 

Approximately $50-$60 one-way.

To and From The Port of Miami

Taxi 

Approximately $7-$10 one-way

Local Transportation

MetroMover 

Adjoins hotel by tunnel and accesses entire downtown area at no charge.

Metrorail 

Metrorail can be reached via the Metromover that adjoins the hotel at the Bank of America Tower.  There are 22 Metrorail stations throughout Miami-Dade County.  The fare for the Metrorail is currently $1.50. 

Car Rental 

Enterprise Rent-A-Car (on-site).  More details to follow.

Parking 

Valet:

0-2 hours $13

2-3 hours $16

3-4 hours $19

4-5 hours $22

Overnight Parking $30

Special events parking $40

Valet parking charges include in and out privileges. No vans, trucks or large vehicles.

Self Parking:

$19, payable by cash or credit card. Self parking is in a garage with no in/out privileges.

Leisure Opportunities & Restaurant Information

For information on area activities and attractions, visit www.miamiandbeaches.com/SQA 

Conference Speakers

Keynote Speaker: Donna Shalala PhD 

Closing Speaker: Paul McKellips 

Keynote Speaker

Donna E. Shalala PhD became Professor of Political Science and President of the University of Miami on June 1, 2001.  President Shalala has more than 30 years of experience as an accomplished scholar, teacher and administrator.

Born in Cleveland, Ohio, President Shalala received her A.B. degree in history from Western College for Women.  One of the country’s first Peace Corp Volunteers, she served in Iran from 1962 to 1964. She earned her Ph.D. from The Maxwell School of Citizenship and Public Affairs at Syracuse University.  She has held tenured professorships at Columbia University, the City University of New York (CUNY), and the University of Wisconsin - Madison.  She served as President of Hunter College of the City University of New York from 1980 to 1987 and as Chancellor of the University of Wisconsin-Madison from 1987 to 1993.

During her tenure, UM has solidified its position among top U.S. research universities. Momentum: The Campaign for the University of Miami, one of the first billion-dollar capital campaigns completed in the United States, raised $1.4 billion in private support for the university’s endowment, academic and research programs and facilities.

In 1993 President Clinton appointed her U.S. Secretary of Health and Human Services (HHS) where she served for eight years, becoming the longest serving HHS Secretary in U.S. history.  At the beginning of her tenure, HHS had a budget of nearly $600 billion, which included a wide variety of programs including Social Security, Medicare, Medicaid, Child Care and Head Start, Welfare, the Public Health Service, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). At the end of her tenure as HHS Secretary, The Washington Post described her as “one of the most successful government managers of modern times.” 

She served in the Carter administration from 1977-80 as Assistant Secretary for Policy Development and Research at the U.S. Department of Housing and Urban Development. 

She is a Director of  the Lennar Corporation and Mednax, Inc.  In 2007, President George W. Bush handpicked Shalala to co-chair with Senator Bob Dole the Commission on Care for Returning Wounded Warriors, to evaluate how wounded service members transition from active duty to civilian society. In 2009 she was appointed chair of the Committee on the Future of Nursing at the Institute of Medicine of the National Academy of Sciences.

President Shalala has more than four dozen honorary degrees and a host of other honors, including the 1992 National Public Service Award, the 1994 Glamour magazine Woman of the Year Award; in 1992, Business Week named her one of the top five managers in higher education; in 2005, she was named one of “America’s Best Leaders” by U.S. News & World Report; in 2008, President Bush presented her with the Presidential Medal of Freedom, the nation’s highest civilian award; and in 2010 she received the Nelson Mandela Award for Health and Human Rights, which recognizes individuals for outstanding dedication to improving the health and life chances of disadvantaged populations in South Africa and internationally.

She has been elected to the Council on Foreign Relations; National Academy of Education; the National Academy of Public Administration; the American Academy of Arts and Sciences; the American Philosophical Society; the National Academy of Social Insurance; the American Academy of Political and Social Science; and the Institute of Medicine of the National Academy of Sciences.

BIOGRAPHY AT-A-GLANCE
CAREER HIGHLIGHTS

2001-  President, University of Miami
1993-2001 Secretary, U.S. Department of Health and Human Services
1987-1993 Chancellor, University of Wisconsin-Madison
1980-1987 President, Hunter College of the City University of New York
1977-1980 Assistant Secretary for Policy Development and Research, U.S. Department of Housing and Urban Development
1972-1979 Associate Professor and Chair, Program in Politics and Education, Teachers College, Columbia University
1962-1964 U.S. Peace Corps Volunteer, Iran 

Closing Speaker

Paul McKellips
Executive Vice President – Foundation for Biomedical Research

Paul McKellips has been a communications professional for his entire career. After 25-years in the motion picture and television industry, McKellips and his family moved to Washington, DC after 9/11 to help in the War on Terror. After covering the Pentagon and State Department for national TV news he joined Voice of America covering the Middle East and then USDA in the press office. McKellips responded to a Presidential directive in 2006 and volunteered for a 1-year assignment in Iraq. Embedded with four Iraqis at a Combat Outpost at the height of “the surge,” McKellips worked as a civilian under the command of General David Petraeus and launched the largest radio and TV station in Iraq located in the volatile Diyala Province. Once back in the US, McKellips co-founded No Greater Sacrifice, a military charity that provides college scholarships to the children of fallen service members from Iraq and Afghanistan. McKellips has written, directed and produced three motion pictures and numerous television programs including the Jonathan Winters Entertainment Show and Star Trek: Next Generation for interactive television. McKellips is an entertaining and motivational speaker and has been with FBR since he returned from Iraq in 2007. Paul’s documentary on breast cancer research received an Emmy nomination in 2011 and FBR’s TV programs, PSAs and billboards have already earned 12 Telly Awards. McKellips was invited by the U.S. military to come to Afghanistan where he is serving on a short-term assignment as NATO’s Public Affairs Planner through July of 2011. His new thriller, UNCAGED, will be available to purchase at the meeting. 

Through his presentation you will

- Get the latest public opinion numbers on animal research from our monthly tracking polls from Zogby International;
- See the TV spots we are currently running and learn how many Americans are watching them;
- See excerpts from a 100 woman focus group in Chicago and learn why 42% of those women changed their minds to support animal research in less than two hours; and
- Receive the latest information about the animal rights groups and what they’re up to.
 

Special Event

Biscayne Lady Luxury Yacht Cruise with Buffet Dinner

Wednesday, 25 April 2012
6:30 – 9:30 pm

With the Miami skyline as the backdrop, enjoy an evening with your SQA colleagues cruising aboard the luxury yacht, “Biscayne Lady.”  The 3-deck, 111-foot catamaran design offers the most stable and comfortable cruising experience on the Biscayne Bay.  Her spacious interior and exterior spaces guarantee a great view. 

As the Lady Biscayne winds her way along the emerald waterways of the Miami harbor and South Florida coastline, you can enjoy the sunset, open air and ever-changing view from one of her three decks. The upper sky deck has a nearly unobstructed 360-degree panoramic view.  We will pass Star Island which boasts to be the home of Miami’s rich and famous.

Boarding directly from the Grand Hyatt conference hotel, the crew will greet you with a welcome drink and appetizers to munch on before the dinner buffet. For dinner, you will enjoy a choice of entrée and two sides, a salad, and a dessert.  Complimentary wine, beer and soda will be available throughout the cruise. Boarding begins at 6:30 PM for a prompt 7:00 PM departure. We will return to dock at 9:30 PM.

Cost: $90 per person 

Special Event registration is completed along with Annual Meeting registration. Space is limited so make your reservations early!

Call for Volunteers

If you are planning to attend the Annual Meeting, please consider volunteering.  Many of the volunteer assignments involve one-on-one interaction with other attendees, presenters, regulators and more!  Whether you volunteer as a Session Monitor at the Annual Meeting or Quality College, or help attendees with registration and directions at the registration desk, you will enjoy the time that you spend as an Annual Meeting volunteer.  We have volunteer tasks and times to fit every schedule.  There are even pre-meeting volunteer assignments for those who want a great excuse to come to Miami a little early!  Your gift of time and talent is greatly appreciated.

If you are interested in volunteering or have questions about it, please contact SQA Manager of Membership Services Emily Collins at emily.collins@sqa.org.