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| Programme Titles Presenters |
| Saturday, 24 April 2010 |
| 9:00 am - 12:00 pm
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Registered Quality Assurance Professional Examinations |
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| Sunday, 25 April 2010 |
| 8:00 am - 5:00 pm
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Quality College |
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| Monday, 26 April 2010 |
| 8:00 am - 5:00 pm
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Quality College |
| 12:00 - 5:00 pm
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Exhibit/Poster Installation
Grand Ballroom B |
| 4:45 - 5:30 pm
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Orientation: SQA Member Resources and Benefits
Hilton Netherland Plaza Hotel, 4th Floor Rookwood |
| 5:30 - 7:00 pm
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Opening Reception
Hilton Netherland Plaza Hotel, Hall of Mirrors |
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| Tuesday, 27 April 2010 |
| 7:30 - 8:30 am
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Networking Continental Breakfast with the Exhibitors and Posters
Grand Ballroom B |
| 8:30 - 10:30 am
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Opening Plenary
Grand Ballroom A |
| 10:30 - 11:00 am
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Networking Beverage Break with Exhibitors and Posters
Grand Ballroom B |
| 11:00 am - 12:00 pm
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Session A - Grand Ballroom A
| A-1 |
A Risk-Based Approach to Auditing Laboratory Processes that Include Electronic Systems |
| A-2 |
Towards Establishing Good Practice in the Use of Computer Prediction
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Session B - Junior Ballroom D
| B-1 |
Good Laboratory Practice Program Update from FDA’s Center for Devices and Radiological Health |
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Session C - Junior Ballroom C
| C-1 |
Thinking Outside The GLP “Box” – Regulatory Concerns For Non-Standard Study Designs |
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Session D - Junior Ballroom B
| D-1 |
GCP Mock Inspections: Real Experiences of a Fake Inspector |
| D-2 |
MHRA – Inspection Readiness Training |
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Session E - Junior Ballroom A
| E-1 |
Comparisons between Human and Animal GCP Auditing |
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| 12:00 - 1:30 pm
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Networking Lunch with the Exhibitors and Posters
Grand Ballroom B |
| 1:30 - 3:00 pm
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Session F - Grand Ballroom A
| F-1 |
Electronic Records – Perspectives from FDA and Industry |
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Session G - Junior Ballroom D
| G-1 |
Starting from Scratch- Designing the Startup Quality System |
| G-2 |
What is the impact of work relationships in your company? |
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Session H - Junior Ballroom C
| H-1 |
An Expatriate’s View of China |
| H-2 |
An Update on Health Canada’s Initiative to Establish a GLP Monitoring Authority (GLP-MA)
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Session I - Junior Ballroom B
| I-1 |
Transfer of Responsibility Does Not Mean Transfer of Accountability |
| I-2 |
Who’s in Charge? Managing Your Trial in the Outsourced World |
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Session J - Junior Ballroom A
| J-1 |
Train the Trainer - Learn the basics for implementing an effective "Train the Trainer program" |
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| 3:00 - 3:30 pm
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Networking Beverage and Snack Break with Exhibitors and Posters
Grand Ballroom B |
| 3:30 - 4:30 pm
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Session K - Grand Ballroom A
| K-1 |
Animal Health Regulatory Update |
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Session L - Junior Ballroom D
| L-1 |
Implementing Agile Software Development Methodology for Regulated Computerized Systems |
| L-2 |
Building an Effective Computer Systems Audit Program |
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Session M - Junior Ballroom C
| M-1 |
Evaluation and Recommendations on Good Clinical Laboratory Practice (GCLP) Guidelines for Phase I-III HIV Vaccine Clinical Trials. |
| M-2 |
A University Case Study: Validate Our Digital Camera System? Say What?! |
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Session N - Junior Ballroom B
| N-1 |
"Is it time to "re-FOCUS" our audit process?" |
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Session O - Junior Ballroom A
| O-1 |
GLP Test Substance Characterization: Are you Ready? |
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| 4:30 - 6:00 pm
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Peripheral Meetings
Various Locations |
| 6:00 - 7:30 pm
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International Networking Reception featuring SQA's own Deviations
Hyatt Regency – Ballroom E&F |
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| Wednesday, 28 April 2010 |
| 7:30 - 8:30 am
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Networking Continental Breakfast with the Exhibitors and Posters
Grand Ballroom B |
| 8:30 - 10:00 am
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Session P - Grand Ballroom A
| P-1 |
The Regulation of Genetically Engineered Animals |
| P-2 |
Quality Review Of Immunogenicity Data |
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Session Q - Junior Ballroom D
| Q-1 |
Effectively Auditing LC-MS/MS Raw Data and Understanding it |
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Session R - Junior Ballroom C
| R-1 |
Critical Phase Inspections – How to Get The Most Bang For Your Buck |
| R-2 |
GLP Amendments, Deviations, And Unforeseen Circumstances – The Good, The Bad And The Ugly |
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Session S - Junior Ballroom B
| S-1 |
Clinical Regulatory Update |
| S-2 |
FDA/EMEA GCP Initiative |
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| 10:00 - 10:30 am
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Networking Beverage Break with Exhibitors and Posters
Grand Ballroom B |
| 10:30 am - 12:00 pm
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Session U - Grand Ballroom A
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Session V - Junior Ballroom D
| V-1 |
The Use of Electronic Communication in a GxP Environment—an Expert Panel Discussion Session |
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Session W - Junior Ballroom C
| W-1 |
Approaches That Universities Can Use To Introduce Regulatory Compliance and Integrity Issues |
| W-2 |
Promoting and Implementing GLPs within a University Environment |
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Session X - Junior Ballroom B
| X-1 |
How Effective is GCP Training, Really? |
| X-2 |
Quality Based Selection of Clinical Sites |
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Session T - Junior Ballroom A
| T-1 |
Demystifying RQAP (moved from 8:30 time slot) |
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| 12:00 - 1:30 pm
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Networking Lunch with the Exhibitors and Posters
Grand Ballroom B |
| 1:30 - 3:00 pm
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Session Y - Grand Ballroom A
| Y-1 |
SQA–FDA Communication |
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Career Development Panel Discussion - Junior Ballroom D |
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Session Z - Junior Ballroom C
| Z-1 |
Root Cause Analysis Tools and Guidelines |
| Z-2 |
Lean Six Sigma/Continuous Process Improvement Impacts on Quality Management Systems |
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Session AA - Junior Ballroom B
| AA-1 |
Electronic Data Capture in Clinical Investigations |
| AA-2 |
The Impact of Electronic Systems, eHRs, and eData on Clinical Research |
| AA-3 |
Maximizing Audit Efficiencies while Utilizing EDC |
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| 3:00 - 3:30 pm
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Networking Beverage and Snack Break with Exhibitors and Posters
Grand Ballroom B |
| 3:30 - 4:30 pm
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Session BB - Grand Ballroom A
| BB-1 |
CVIC Regulatory Update |
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Session CC - Junior Ballroom D
| CC-1 |
SQA Mentoring Program Initiation: Shared Experiences Plus Updates For The Next Application Cycle |
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Session DD - Junior Ballroom C
| DD-1 |
The Future of GLPs: Modernization and Globalization |
| DD-2 |
China SFDA's "International Workshop on GLP Inspection": A Presenter's Perspective |
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Session EE - Junior Ballroom B
| EE-1 |
How does Quality Risk Management work in practice? |
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| 4:30 - 6:00 pm
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Peripheral Meetings
Various Locations |
| 6:30 - 10:00 pm
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Offsite Special Event - Newport Aquarium |
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| Thursday, 29 April 2010 |
| 7:30 - 8:30 am
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Networking Continental Breakfast
Grand Ballroom B |
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Annual Business Meeting of Members
Level 2, Room 235 |
| 8:30 - 10:00 am
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Session FF - Grand Ballroom A
| FF-1 |
Auditing Veterinary GCP Studies: A Trilogy |
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Session GG - Junior Ballroom D
| GG-1 |
Building a Better Way: The Evolution of eDC/Clinical Database Validation Processes |
| GG-2 |
No Worries, the Data Came from the EMR…or are there? |
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Session HH - Junior Ballroom C
| HH-1 |
Current Status and Future Directions of Pathology Peer Review |
| HH-2 |
Ensuring the Integrity of Your Samples During Global Transport |
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Session II - Junior Ballroom B
| II-1 |
GCP Requirements for Pharmaceutical and Medical Device Clinical Trials—How Do They Differ? |
| II-2 |
Dealing with an FDA Audit - What we can learn from Warning Letters and Audits |
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| 10:00 - 10:30 am
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Networking Beverage Break
Grand Ballroom B |
| 10:30 am - 12:00 pm
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Session JJ - Grand Ballroom A
| JJ-1 |
International GLPs: Use of OECD GLPs and Guidance 13 in the United States, and
Comparison of the Practical GLP Interpretation Among Tripartite Countries
Coordinated by the Animal Health Specialty Section and the GLP Specialty Section. |
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Session KK - Junior Ballroom D
| KK-1 |
How to be a Good Independent Contractor |
| KK-2 |
From Discovery to Market – Developing A Safe and Effective Quality Training Program |
| KK-3 |
Quality Circles: The Strength they provide in a Total Quality Management Organization |
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Session LL - Junior Ballroom C
| LL-1 |
Increasing Value of the Bioanalytical Laboratory's SOPs |
| LL-2 |
Auditing Chromatographic Electronic Data |
| LL-3 |
The Odd Couple: A Successful Partnership Between QA and IT in a Bioanalytical Environment |
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Session MM - Junior Ballroom B
| MM-1 |
Facing the Challenges of Pharmacovigilance in Evolving Cultures of Safety |
| MM-2 |
Clinical Trial Oversight and Adverse Event Reporting |
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| 12:00 - 1:30 pm
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Networking Lunch
Grand Ballroom B |
| 1:30 - 3:00 pm
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Closing Plenary |
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| Friday, 30 April 2010 |
| 8:00 am - 5:00 pm
|
Quality College |
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