SQA 26th Annual Meeting and Quality College

Sunday - Friday, 25 - 30 April 2010

Duke Energy Convention Center

Cincinnati, Ohio, USA

Quality College was held Sunday - Monday, 25 - 26 April 2010 and Friday, 30 April 2010, consisting of full-day and half-day workshops. 

The Conference was held Tuesday – Thursday, 27 - 29 April 2010.  Three days of plenary and concurrent sessions explored hot topics and the latest regulatory interpretations in the field.   Sessions focused on regulatory-based topics in manufacturing (GMPs), preclinical (GLPs) and clinical (GCPs) research arenas.  Other areas of interest represented included animal health, bioanalysis, biotechnology, computer validation, medical devices, scientific archiving, university issues and much more.

View the conference program (includes abstracts for oral presentations)

Thanks to all the attendees, exhibitors and supporters who helped make this meeting a success!

Sessions

The Conference will be held Tuesday – Thursday, 27 - 29 April 2010.  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 represented include animal health, bioanalysis, biotechnology, computer validation, medical devices, scientific archiving, university issues and much more.

Session Composition

Abstracts for sessions are 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. The SQA Program Committee reviewed the abstracts and placed them into the program by topic.  Training Workshops are developed by the SQA Education Committee and subject experts were invited to give presentations during these workshops. 

View the conference program (includes abstracts for oral presentations)

Quality College

The SQA Quality College training courses will be held before and after the conference.  Courses will be offered Sunday, 25 April 2010, Monday, 26 April 2010 and Friday, 30 April 2010, consisting of two-day, one-and-a-half-day, one-day and partial-day workshops.

All courses are a single full day unless otherwise indicated.  Click the course title below for more information on the course.

Sunday, 25 April 2010

1-Basic Training: Good Laboratory Practice

2-Good Clinical Practice: Understanding the Basics (1.5-day course, all day on Sunday and in the morning on Monday)

3-Basic Computer Validation (2-day course, all day Sunday and Monday)

4-Selected Topics in Bioanalytical Auditing

5-Biotechnology: Methodology and Auditing

6 & 7-Public Speaking Workout (0.5-day course; 2 identical sections being offered, one in the morning and one in the afternoon, each section limited to 15 participants)

8-From Lab to Market: Getting Regulatory Approval (0.5-day course, morning)

9-Introduction to SQA Leadership (0.5-day course, afternoon; complimentary for SQA members)

Monday, 26 April 2010

10-Current Topics in Good Laboratory Practice

11 & 12-Preparing for and Hosting a Government Inspection (2-hour course; 2 identical sections being offered, both in the afternoon, no lunch provided with either section)

13-Delivering High Quality GLP and vGCP Animal Studies (0.5-day course, morning)

14-Addressing Challenges to Achieve High Quality GLP and vGCP Animal Studies (0.5-day course, afternoon)

15-Personal Development and Effectiveness for Quality Assurance Professionals

16-Understanding the GxPs: Bridging the Communication Gap

Friday, 30 April 2010

17-Advanced Topics in GCP: A Global GCP QA Workshop and Seminar

18-Auditing Software and Data Providers (0.5-day course, morning)

19-Process Mapping (0.5-day course, afternoon)

20-Continual Quality Improvement: Expanding the QA Toolbox

21-Non-Clinical Medical Device Compliance in a Changing Climate

22-Creeping GMPs (0.5-day course, morning)

23-GLP in the Bioanalytical Lab: An Intended Purpose Approach from Good Science towards Compliance (0.5-day course, afternoon)

Usual Quality College Schedule

07:00 a.m. - 05:00 p.m.                      Registration

07:00 a.m. - 08:00 a.m.                      Networking/Continental Breakfast

08:00 a.m. - 10:00 a.m.                      Workshops

10:00 a.m. - 10:15 a.m.                      Networking/Beverage Break

10:15 a.m. - 12:00 p.m.                      Workshops Continued

12:00 p.m. - 01:00 p.m.                      Networking/Lunch Buffet

01:00 p.m. - 03:00 p.m.                      Workshops Continued

03:00 p.m. - 03:15 p.m.                      Networking/Beverage and Snack Break

03:15 p.m. - 05:00 p.m.                      Workshops Continued

Posters

The Poster Session will be held Tuesday - Wednesday, 27 - 28 April 2010.  Presenters are asked to be at their posters for comment on Tuesday, 27 April 2010, 12:45 - 1:30 p.m.

Instructions for Poster Presenters

Each accepted poster counts as one credit towards RQAP re-registration.  Technical abstracts will be published online by the Quality Assurance Journal (John Wiley & Sons), and all abstracts will be published in the Annual Meeting Program Book.  Notifications of abstract acceptance were sent in December 2009.

Abstracts

SQA thanks all who submitted an abstract for consideration for the 26th SQA Annual Meeting.  The Program Committee invited submissions on all regulatory QA topics for presentation:  manufacturing (GMPs), preclinical (GLPs) and clinical (GCPs).  The Committee welcomed abstracts on other areas of interest as well, including animal health, bioanalysis, biotechnology, computer validation, medical devices, scientific archiving, university issues and much more.

Notifications of abstract acceptance were sent in December 2009. 
 

All presenting authors of abstracts accepted for presentation will be required to register for the Conference and pay the appropriate fees, in accordance with the published fee schedule.  Technical abstracts will be published online by the Quality Assurance Journal (John Wiley & Sons) and in the Annual Meeting Program Book.

Special Events

Tuesday, 27 April 2010, 7:00 - 8:00 am

Join us to learn more about the benefits and resources available to SQA members.

Opening Reception  

Monday, 26 April 2010, 5:30 pm - 7:00 pm 

The Annual Meeting Opening Reception is planned for Monday, 26 April 2010, from 5:30 - 7:00 pm.  This reception is complimentary for all full conference attendees and includes light hors d’oeuvres, a ticket for a free drink and great entertainment. Plan to attend in order to greet and meet fellow colleagues, then network to make dinner plans to explore the variety of restaurants Cincinnati offers.  Additional reception tickets may be purchased for $50.00 at the Registration table.  Please be sure to wear your badge to the event; it serves as your admission ticket.

The Newport Aquarium is located In Newport, Kentucky, across from downtown Cincinnati at Newport on the Levee.  Newport on the Levee is a premier leisure-time destination featuring sixteen fine restaurants, a comedy club featuring nationally-known comedians, a live sketch comedy and rock-n-roll club, the AMC Newport 20 Cinemas, street performers, live music and unique shopping.  After dinner at the Aquarium, feel free to explore Newport on the Levee.  The last bus back to the hotels from the Levee will depart at 11:00 pm. 

Tickets are $75.00 per person. Registration prior to the meeting is required.

Registration

View the conference program (includes abstracts for oral presentations)

If you prefer to pay by check, please register onsite. 

Registration Policies

Refund Policy:  Refund requests must be made in writing to SQA Headquarters.  A full refund of the Conference and Training registration fees, minus a $55 processing charge, will be made for cancellations on or prior to 18 February 2010.  A 75% refund will be made for cancellations from 18 February 2010 to 26 March 2010.  A 50% refund will be given for cancellations from 26 March 2010 to 10 April 2010.  No refunds will be made for requests received after 10 April 2010.

Substitution Policy:  If you find that you are unable to attend Preconference Training or the Conference, you may send a substitute in your place.  Each registration substitution will be charged a $55 processing fee.  If a non-member is substituted for a member, the additional cost for a non-member will be charged.  Conversely, if a member is substituted for a non-member, the difference will be refunded.

Session Change Policy:  If you have registered for a Preconference Training session and would like to attend a different session, you may change your registration.  Each session change will be charged the 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 Preconference Training or the Conference based on 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.
 

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. The selection criteria are as follows:

The applicant shall be an Active member of SQA, in good standing, and shall have been an Active member for at least one year.

Self nominations shall be accepted.

Application shall be submitted in written form, and shall include a letter specifying the name of the scholarship for which the individual is applying, what is hoped to be gained by participation in the Annual Meeting, and a list of activities dedicated to service to SQA or its Regional Chapters. The application and letter must be accompanied by a current CV.

 Past Presidents Scholarship Award 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. The selection criteria are as follows:

The applicant shall be an Active Member of SQA, in good standing, and shall have been an Active member for at least one year.

The applicant shall be currently self-employed as an independent consultant.

Self nominations shall be accepted.

Application shall be submitted in written form, and shall include a letter specifying the name of the scholarship for which the individual is applying, what is hoped to be gained by participation in the Annual Meeting, and a list of activities dedicated to service to SQA or its Regional Chapters. The application and letter must be accompanied by a current CV.

Pamela H. Errico Memorial Scholarship Award Application Form 

Application forms must be received, along with required documentation listed above, at SQA Headquarters no later than 30 January 2010 for the 2010 Annual Meeting. If the selected recipients already have paid registration fees for the 2010 Annual Meeting, those fees will be refunded.

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

Keynote Speaker

Dr. Kurt Weingand

The Program Committee is pleased to announce that Dr. Kurt Weingand will be delivering the keynote address at the 26th SQA Annual Meeting. As a change to the program this year, Dr. Weingand will also deliver a motivational closing address that will energize all meeting attendees!

Keynote Presentation: Lessons in Leadership for Crisis Management
This presentation shares key experiential learnings from management of the 2007 pet food recall. This was the largest consumer packaged goods product recall in history affecting over 100 brands globally. Procter & Gamble (P&G) Pet Care was the first premium pet food company to detect the pet health issue, initiate a voluntary recall of the affected wet pet foods, discover the cause of the problem (contamination with melamine-cyanuric acid), and work with the FDA to develop a plan for resolution of the issue. This presentation is rich in learnings about the crisis management process, government interactions, and management of communications with media, pet health care professionals, pet owners, and employees. Dr. Kurt Weingand was the global crisis team leader for P&G Pet Care during this product recall.

Closing Plenary Address: A Peculiar Career in Life Sciences With and Without Quality Assurance
End the meeting with Dr. Weingand's humorous look at a lifetime career in life sciences with (and mostly without) the known benefits of quality assurance. This multi-media display of scientific excellence and communications will be entertaining. What a great way to end the meeting!

Dr. Kurt Weingand trained in veterinary medicine and surgery at the University of Missouri and received his D.V.M degree in 1980. He worked in a companion animal veterinary clinic for a year then enrolled as a National Cancer Institute trainee in the graduate program at Colorado State University and obtained a Ph.D. degree in Pathology in 1984. Dr. Weingand’s first academic appointment was at the Wake Forest University School of Medicine where he led research on mechanisms of coronary artery atherosclerosis. Dr. Weingand became a Diplomate of the American College of Veterinary Pathology by earning board certification as a veterinary clinical pathologist in 1985. He then became an Assistant Professor of Laboratory Medicine at Kansas State University’s College of Veterinary Medicine leading research on body fat distribution as a risk factor for coronary artery disease and providing clinical pathology instruction and service in the veterinary teaching hospital.

Dr. Weingand joined Procter & Gamble (P&G) in 1988 to lead toxicologic pathology research in support of pre-clinical safety assessments. In this role, he led an international task force that developed harmonized guidelines for clinical pathology testing in pre-clinical toxicity and safety studies. Dr. Weingand transferred to P&G Health Care in 1993 as a clinical scientist to lead the conduct of human clinical trials on a variety of health care products (Metamucil, Pepto-Bismol, NyQuil, Vicks). In 1997, he led product development of a new non-drug topical analgesic product that culminated in the launch of ThermaCare HeatWraps in 2000. In 2001, Dr. Weingand began his leadership role in the P&G Health Sciences Institute to lead technical outreach of new research information and serve as the external spokesperson for OTC Health Care brands.  He advanced to Associate Director of Global External Relations where he led commercial innovation for the launch of Prilosec OTC in 2004. In 2006, he was appointed to lead P&G Pet Care’s alternative animal models development program and site operations in research & development at the Lewisburg Innovation Center. Dr. Weingand accepted responsibility for P&G Pet Care’s Global External Relations organization in 2007 to lead Scientific Communications, Professional Relations, Public Relations, Consumer Relations, Corporate Reputation, Government Relations, and Crisis Management for the Iams and Eukanuba brands. He led the P&G Pet Care global crisis team during the 2007 Menu Foods pet food recall Dr. Weingand is currently the President of SciComPro-LLC, a privately held life sciences consulting firm.  He was the host and co-producer of Health Today, a weekly talk radio program on 55KRC in Cincinnati, Ohio.

Dr. Weingand is currently a Principal Investigator in clinical trials of medical devices for Pfizer, a board member on the Goodwyn IRB, and also works as a clinical pathologist at Veterinary Pathology Services, Inc. in Mason, OH.

Thank you for your participation in the 25th SQA Annual Meeting, to be held 25 - 30 April 2010.

Please see the following deadlines and documents pertinent to your role as a Conference Speaker or Poster Presenter:

The following AV will be available in session rooms:

Projector, screen, podium microphone, head table microphone, 2 floor microphones, wireless lav microphone, laptop computer and a laser pointer

If you would like to request additional AV, and have not already done so through the abstract system, please e-mail Alison Holcomb at alison.holcomb@sqa.org by 12 March 2010.

Conference speakers are required to register for the Conference and pay the appropriate registration fees. Conference speakers who are registering for the 3-day Conference receive a $100 discount on registration. Conference speakers registering for One Day Only receive a $50 discount. Please see the Registration page for details.  Please register and make your hotel reservations no later than 26 March 2010.

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

Please note that this information DOES NOT apply to the Pre- or Post-conference Training. If you are speaking during the Training, please contact your Session Chair for information.

Hotel - Rooms are still available at the Hilton at the group rate!

The SQA 26th Annual Meeting will be held at the Duke Energy Convention Center.  The SQA conference hotels are the Hilton Cincinnati Netherland Plaza Hotel and the Hyatt Regency Cincinnati.  SQA has been able to negotiate very favorable rates for participation at this Conference and rates at both hotels include free room internet. 

Hilton Cincinnati Netherland Plaza Hotel
(Located one block from the Duke Energy Convention Center)
35 West Fifth Street
Cincinnati, Ohio  45202
+1-513-421-9100
www.cincinnatinetherlandplaza.hilton.com

• SQA Conference room rate: $135 (single/double), exclusive of applicable taxes/fees.

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

• SQA group rates are extended three days prior to and three days following the dates of the Conference on a space available basis.

• SQA cannot guarantee the group rate for reservations made at either conference hotel after 31 March 2010.

• 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 reserve your room online for the Hilton Cincinnati Netherland Plaza Hotel, please visit http://www.hilton.com/en/hi/groups/personalized/CVGNPHF-SQA-20100420/index.jhtml

Government Employees: Reserve your room at the government rate online at http://www.hilton.com/en/hi/groups/personalized/CVGNPHF-SOG-20100419/index.jhtml
You must present valid ID upon checkin

You can also call Hilton Hotels directly at 1-800-HILTONS (445-8667).  In order to receive the special group discounted rate, you must specify that you are with the SQA Conference.

Hyatt Regency Cincinnati
(Located across the street from the Duke Energy Convention Center)
151 West 5th Street
Cincinnati, Ohio  45202
+1 513-579-1234
www.cincinnati.hyatt.com

• SQA Conference room rate: $139 (single/double), exclusive of applicable taxes/fees.

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

• SQA group rates are extended three days prior to and three days following the dates of the Conference on a space available basis.

• SQA cannot guarantee the group rate for reservations made at either conference hotel after 31 March 2010.

• 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 by 3pm Eastern Standard Time 24 hours prior to arrival with no penalty

To reserve your room at the Hyatt Regency Cincinnati, please visit https://resweb.passkey.com/go/dqal  OR call the hotel directly at +1 800-233-1234. In order to receive the special group discounted rate, you must specify that you are with the SQA Conference.

We urge you to make your hotel reservation at our conference hotels 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 hotels.

Travel

Airport

Cincinnati is serviced by the Cincinnati Northern Kentucky Airport Terminal (CVG).  The conference hotels are approximately 13 miles from the airport (about 20 minutes away).

SQA has arranged a discount with Executive Airport Shuttle for transportation to and from the airport. 
$20 one way
$25 roundtrip

Please call +1.800.990.8841 ( or +1.859.261.8841 if outside the US) to make your reservations.  Remember to specify the SQA conference to receive your discount.

Taxi: Approximately $25 one way

Amtrak: 10 minutes from the conference hotels, stops at Union Terminal.

Leisure Opportunities

For information on area activities and attractions, visit www.CincyUSA.com/SQAAM.

Weather

Consultants

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 Marketing Functions during online event registration or you may download the  Consultant Members Table Registration Form  to pay via check.

Exhibits

Exhibit Days:  27 - 28 April 2010

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. Exhibitors will be listed in the Conference Program, on signage at the meeting, in SQA Newsletters and on the Conference website, and will receive all meeting materials, including the Conference Program and gifts.

Exhibit Registration is now open! Please download the  Exhibitor and Supporter Prospectus for details.

Booths and tables will be assigned on a first-come-first-served basis, so reserve your space early.  View the List of Exhibitors and Exhibit Floorplan

Exhibitor Fees

The Exhibitor fee includes registration for one attendee and the cost of the reserved marketing space. Second exhibit booth representatives may register for an additional booth representative fee of $300.00.

Exhibitors will receive: 

Exhibit Listing and Floorplan

Corporate Supporters

Please download the  Exhibitor and Supporter Prospectus. 

General Sponsorship

Conference Sponsors help underwrite some of the meeting expenses in exchange for recognition in the Conference Program, on signage at the meeting, in SQA Newsletters and on the Conference 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 2009

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 Conference attendees. These gifts will be included in the Conference carry bag, which includes the Conference Program and Abstract Book, preregistration list, and other materials and is 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 organization to nearly 900 expected on-site attendees in Cincinnati. 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. SQA members and non-members from the US, Canada and around the globe will attend this meeting.

Volunteer Opportunities

Call for Volunteers

If you are planning to attend the Conference, 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 Training Sessions, 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 Cincinnati a little early!  Your gift of time and talent is greatly appreciated.

SQA has set up a volunteer sign-up schedule using the SuperSaas web tool.  You will need to create an account with SuperSaas in order to sign up for volunteer activities so that the website can allow you to change your schedule in the future (if you were not required to sign up, there would be no way for you to cancel your volunteering for something if you later discovered you were unavailable at that time).  To access the volunteer schedule, click the link below.  Use the calendar to navigate through the days of the Annual Meeting, and click on a volunteer opportunity on the calendar in order to sign up for it.

Click here to volunteer your time during the 26th SQA Annual Meeting!

If you have questions about volunteering, contact SQA Volunteer Coordinator Moira Bandoli at mbandoli@sbcglobal.net or SQA Program Director Alison Holcomb at alison.holcomb@sqa.org.