28th SQA Annual Meeting and
Sunday - Friday, 22 - 27 April 2012
Miami Hyatt Regency
Miami, Florida, USA
Thank you to all who planned, supported and attended the meeting! Special thanks to our presenters and volunteers! Everyone's participation made it a great success!
Quality College was 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 was 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.
RQAP Registration Units
The meeting qualified for RQAP units as follows.
Full conference: 4.75 GCP or GLP re-registration units
Tuesday only: 1.75 GCP or GLP re-registration units
Wednesday only: 1.75 GCP or GLP re-registration units
Thursday only: 1.25 GCP or GLP re-registration units
Quality College Courses also qualified - see the tab above for details.
April 2012 SQA Quality College
22, 23 and 27 April 2012
Miami, Florida, USA
The Society of Quality Assurance Education Committee hosted three days of events dedicated to networking and education for Quality Assurance professionals! Each function of this event will counted towards fulfilling the requirements of RQAP re-registration. These courses were held in conjunction with the 28th SQA Annual Meeting, 24 - 26 April 2012.
Below is the list of the functions that were offered. Click on the course title to view the course description and pricing.
Sunday, 22 April 2012
Monday, 23 April 2012
Friday, 27 April 2012
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.
Abstracts were requested on the following hot topics:
||• Adequacy of FDA Submissions - Learning from Incomplete Letters (intermediate or advanced)
• Challenges with Biologics - US vs. Global Submissions (intermediate or advanced)
• Best QA Practices (all levels)
• Risk Based Approaches to Auditing (intermediate or advanced)
• Lifecycle QA (advanced)
• Bioequivalency Studies (all levels)
• Archiving (intermediate or advanced)
• GLP and total quality, how QA involved with GLP fits into the overall quality structure of a company
• Applying Deming's Total Quality Principles in the Regulatory Environment: The Quality Assurance Professional's Secret Toolkit
• Develop a Process Map to identify, reduce and eliminate compliance issues
• What Metrics Should a Quality Assurance Professional Collect and How to Use Them
||• Global harmonization of Bioanalytical processes (intermediate)
• Analysis of clinical samples using GLP standards (intermediate)
• Stability assessments in the presence of co-administered compounds (advanced)
• Advancements in data acceptance/rejection criteria (e.g., internal standard criteria) (advanced)
||• Ligand Binding Assays - Audit Techniques (QA Perspective)
• QA Resource Management - "GLP on a Shoestring Budget"
• GLP Biotechnology Studies - EPA Perspective
|Good Clinical Practices
|Good Laboratory Practices
||• Pathology peer review: Timing, SOPs, Auditing, consultation vs. peer review, etc.
• Report Construction: Draft individual scientist reports, draft non-clinical study reports, sponsor access to draft reports
• Influence of handheld devices and other new technology
• Impact of social media
• Archiving electronic records
• ISR testing: Who is responsible, sponsor or CRO?
• Cloud computing
• New biological areas: stem cells, etc.
• Unique challenges surrounding large molecule studies
• Testing involving blood spotting
• Digital images: managing electronic files, validation, etc.
|Good Manufacturing Practices
||• ICH Q11, Development and Manufacture of Drug Substances: Impact and Implementation (intermediate to advanced)
• Contract Manufacture in India and China: Benefits and Challenges (intermediate to advanced)
• GMP Considerations for Cell Therapy Products (basic to intermediate)
• Design and Conduct of Stability Studies (basic)
• GMP Enough?: From TOX Lots to Commercial - defining a stepwise risk-based approach to quality across drug development (intermediate to advanced)
• Warning Letter Trends and How to Avoid Them (basic to intermediate)
• GMP Application for the QA Professional: From SOP approval to Batch Release (basic to intermediate)
• QA Under Fire: Advanced Strategies for QA Professionals (intermediate to advanced)
||• Electronic auditing and evaluations (e.g., performing QA audits or evaluations by Contributing Scientists via Skype, cameras or recordings) (intermediate)
• Use of CAPA in the GLP environment (basic)
• 2010 Cardiovascular Device Guidance Document (intermediate)
• Update on Part 11 inspections (intermediate)
• Use of Electronic lab notebooks and data collection systems in the GLP environment (basic)
• The creep of GMP/ISO practices into GLP labs (basic)
||• Cultural differences between industry and academia
• Financial modeling to move from a non-compliant to a completely compliant site
• How to incorporate quality into the upstream research processes
• Mixed GLP and non-GLP environments in the university setting
• Computer validation, electronic records and Part 11 compliance in university and academic health center settings
• Novel drug development in the university
• Managing the University QAU
updated 4 August 2011
Thank you to all who registered for the conference.
Through 26 March 2012: $655
After 26 March 2012: $760
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
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:
| Date of Cancellation
|Through 22 February 2012
||Full, less $55
|23 February – 22 March 2012
||75%, less $55
|23 March – 12 April 2012
||50%, less $55
|13 April 2012 and later
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.
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
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.
Thank you to our consultants who participated!
Consultant Member Table space was open to the independent SQA member consultants who registered to attend the Annual Meeting.
Consultant Table Space Registration Fee - $55.00
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.
The 2012 SQA Annual Meeting offered exhibitors the opportunity to market their organizations to over 700 attendees! Exhibitors were in the center of high traffic events that offered 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.
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.
Several supporter opportunities were offered. Many thanks to our supporters who helped make the Annual Meeting possible!
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.
2012 Corporate Supporters
Biotechnical Services Inc
EPL Archives, Inc.
Pacific Rim/West Coast Quality Training
Quality Associates, Inc
Seventh Wave Laboratories
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!
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
400 South East Second Avenue
Miami, Florida, USA 33131 Tel: +1 305 358 1234 Fax: +1 305 358 0529
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.
Hyatt Regency Details:
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.
To and From Miami International Airport:
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.
Approximately $20-$25 one-way.
To and From Fort Lauderdale Airport
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.
Approximately $50-$60 one-way.
To and From The Port of Miami
Approximately $7-$10 one-way
Adjoins hotel by tunnel and accesses entire downtown area at no charge.
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.
Enterprise Rent-A-Car (on-site). More details to follow.
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.
$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
Keynote Speaker: Chuck Tompkins Closing Speaker: Paul McKellips
Corporate Curator Zoological Operations SeaWorld Parks & Entertainment
Chuck is currently Corporate Curator of Zoological Operations for SeaWorld Parks & Entertainment. In this role, he is responsible for animal husbandry, applied animal behavior, animal transportation and global consulting for all of SeaWorld Parks and Entertainment. The parks that display animals include SeaWorld Orlando, SeaWorld San Diego, SeaWorld San Antonio, Discovery Cove Orlando, Busch Gardens Tampa and Busch Gardens Williamsburg. During a tenure that exceeds thirty four years at SeaWorld, with much of that time served as Vice President of Animal Training for Sea World of Florida, Chuck has helped develop industry-leading behavior modification techniques for all species of animals at the SeaWorld Parks.
Chuck has experience with over 100 animal species including killer whales, dolphins, pinnipeds, primates, psittacines, raptors, hoofed-stock and canines. He is also a Florida state-certified and federally-permitted Master Falconer. He has authored and co-authored over a dozen peer-reviewed scientific papers on applied animal behavior and has won numerous awards from the International Marine Animal Trainers Association.
In 2001, Chuck co-authored a New York Times best seller, Whale Done!, with Ken Blanchard (One Minute Manager). In 2009 the same team co-authored another best seller, Whale Done Parenting. As a result, Chuck frequently presents keynote speeches and seminars nationally promoting the power of positive relationships.
He holds professional memberships in the International Marine Animal Trainers Association, the Association of Zoos and Aquariums, and the Animal Behavior Management Alliance. Chuck has served as the Training Advisor for Canine Companions for Independence (Florida Region) and has been on the executive board for the Central Florida Blood Bank and Boys and Girls Club. He is also a past executive board member of the American Cancer Society.
Chuck resides in Windermere, Florida with his wife Kathy.
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.
Biscayne Lady Luxury Yacht Cruise with Buffet Dinner
Wednesday, 25 April 2012
6:30 – 9:30 pm
With the Miami skyline as the backdrop, participants enjoyed an evening with their 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 guaranteed a great view.
As the Lady Biscayne wound her way along the emerald waterways of the Miami harbor and South Florida coastline, guests enjoyed 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. The cruise passed Star Island which boasts to be the home of Miami’s rich and famous.
Boarding directly from the Grand Hyatt conference hotel, the crew greeted guests with a welcome drink and appetizers to munch on before the dinner buffet. Dinner offered a choice of entrée and two sides, a salad, and a dessert. Complimentary wine, beer and soda were be available throughout the cruise.
Call for Volunteers
Many thanks to our wonderful volunteers without whom the Annual Meeting would not be possible!
Many thanks also to SQA Volunteer Coordinator, Moira Bandoli!
Many of the volunteer assignments involved one-on-one interaction with other attendees, presenters, regulators and more! Volunteers served as a Session Monitor at the Annual Meeting or Quality College, helped attendees with registration and directions at the registration desk, and much more. There were even pre-meeting volunteer assignments for those who wanted a great excuse to come to Miami a little early! Their gifts of time and talent are greatly appreciated.