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28th SQA Annual Meeting and Quality College 2012
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April 24, 2012 - Tuesday
 
A-1 - Partly Cloudy Compliance 
$30.00
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Date/Time:
April 24, 2012   10:30am - 12:00pm
 
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B-1 - Industry Perspective on Quality Management Systems (QMS) and Outsourcing - Challenges and Expectations 
$30.00
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Date/Time:
April 24, 2012   10:30am - 11:00am
 
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C-1 - Analytical Equipment Peripheral to Computer Software Used in GLP, GMP and GCP: Harmonizing Approaches for Equipment Qualification and Computer System Validation 
$30.00
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Date/Time:
April 24, 2012   10:30am - 11:30am
 
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D-1 - Metrics: Collection and Use for the QA Professional 
$30.00
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Date/Time:
April 24, 2012   10:30am - 11:30am
 
Format:
       
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E-1 - Ethics, Misconduct and Fraud, OH MY! 
$30.00
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Date/Time:
April 24, 2012   10:30am - 12:00pm
 
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B-2 - Bioanalytical Advancements in Data Acceptance/Rejection Criteria 
$30.00
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Date/Time:
April 24, 2012   11:00am - 11:30am
 
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B-3 - Recent Trends in FDA 483s Specific to Regulated Bioanalysis 
$30.00
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Date/Time:
April 24, 2012   11:30am - 12:00pm
 
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C-2 - Development of a Robust CAPA Management Process in the GCP and Clinical Quality Assurance Arena 
$30.00
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Date/Time:
April 24, 2012   11:30am - 12:00pm
 
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D-2 - The What, When, Why, Where and How of Metrics 
$30.00
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Date/Time:
April 24, 2012   11:30am - 12:00pm
 
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F-1 - Vendor Audits with a Touch of Cloudiness - Key Items to Evaluate During a Vendor Audit & Panel Discussion of Cloud Hosting and Common Observations 
$30.00
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Date/Time:
April 24, 2012   1:30pm - 3:00pm
 
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G-1 - The Changing Role of Quality Assurance in Good Laboratory Practices (21 CFR 58) 
$30.00
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Date/Time:
April 24, 2012   1:30pm - 2:00pm
 
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H-1 - From Project Risk to Inspection Readiness: Ongoing Compliance Assessment from Award to Close-out 
$30.00
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Date/Time:
April 24, 2012   1:30pm - 2:00pm
 
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I-1 - Mixed GLP and Non-GLP Facilities: Learn How this Does Work! 
$30.00
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Date/Time:
April 24, 2012   1:30pm - 2:30pm
 
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J-1 - Self-Defense for Facilities in Multisite Studies 
$30.00
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Date/Time:
April 24, 2012   1:30pm - 2:15pm
 
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G-2 - QA Programs in 2012 and the Future 
$30.00
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Date/Time:
April 24, 2012   2:00pm - 2:30pm
 
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H-2 - GCP Auditing Implications Related to the FDA Guidance on Risk-Based Approach to Monitoring 
$30.00
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Date/Time:
April 24, 2012   2:00pm - 2:30pm
 
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J-2 - Practical Application of the Cardiovascular Animal Studies Guidance Document 
$30.00
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Date/Time:
April 24, 2012   2:15pm - 3:00pm
 
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G-3 - International Regulatory Bodies - Inspectional Adventures in GLP Compliance 
$30.00
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Date/Time:
April 24, 2012   2:30pm - 3:00pm
 
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H-3 - Increased Use of Electronic Medical Records - Challenges for an Auditor 
$30.00
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Date/Time:
April 24, 2012   2:30pm - 3:00pm
 
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I-2 - Mitigating Regulatory Risks Surrounding Nonclinical Cell Study Designs: Live Cells! and PCR! and Tumorgenicity! Oh My! 
$30.00
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Date/Time:
April 24, 2012   2:30pm - 3:00pm
 
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L-1 - Overview of the European Medicines Agency (EMA) Guideline on Bioanalytical Method Validation 
$30.00
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Date/Time:
April 24, 2012   3:30pm - 4:30pm
 
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M-1 - How Will the New FDA Monitoring Guidance Affect Auditing a Phase I Clinical Pharmacology Unit? 
$30.00
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Date/Time:
April 24, 2012   3:30pm - 4:00pm
 
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N-1 - Applying Quality Principles to Improve the Impact of Quality Assurance 
$30.00
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Date/Time:
April 24, 2012   3:30pm - 4:00pm
 
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O-1 - The Basics of Digital Images and Their Use in GLP Studies 
$30.00
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Date/Time:
April 24, 2012   3:30pm - 4:00pm
 
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M-2 - Nigerian Regulatory Frameworks for Clinical Trials: Responses to Varied Perceptions of Global Research Stakeholders 
$30.00
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Date/Time:
April 24, 2012   4:00pm - 4:30pm
 
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O-2 - Auditing Pathology Data: Does GLP Really Stand for "God Loves Pathologists"? 
$30.00
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Date/Time:
April 24, 2012   4:00pm - 4:30pm
 
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April 25, 2012 - Wednesday
 
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P-1 - The ITCy Bitsy Session: Hot Topics in Computerized Systems 
$30.00
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Date/Time:
April 25, 2012   8:30am - 10:00am
 
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R-1 - Advanced Skills and Techniques for Detecting and Preventing Scientific Misconduct 
$30.00
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Date/Time:
April 25, 2012   8:30am - 10:00am
 
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S-1 - Difference Between US FDA and China SFDA GLP 
$30.00
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Date/Time:
April 25, 2012   8:30am - 9:00am
 
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S-2 - Medical Device Regulatory Update 
$30.00
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Date/Time:
April 25, 2012   9:00am - 10:00am
 
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U-1 - Changing a GLP Data Collection & Management System from a Traditional Implementation to a SaaS Deployment 
$30.00
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Date/Time:
April 25, 2012   10:30am - 11:15am
 
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W-1 - Will Risk-Based Monitoring Affect Clinical Quality Assurance Processes and Procedures? 
$30.00
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Date/Time:
April 25, 2012   10:30am - 11:15am
 
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X-1 - Scientists and Sponsors Advocating for the Early Adoption of Voluntary Quality Practices in Research 
$30.00
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Date/Time:
April 25, 2012   10:30am - 12:00pm
 
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U-2 - Auditing Software-as-Service Providers, Data Centers, and Cloud Computing Environments 
$30.00
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Date/Time:
April 25, 2012   11:15am - 12:00pm
 
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  Synched Audio / Video / Slides
 

 
W-2 - Utilizing a Risk-based Approach to Meet Sponsor Monitoring Obligations 
$30.00
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Date/Time:
April 25, 2012   11:15am - 12:00pm
 
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Z-1 - Beyond Just Testing: Alternative Methods for Gaining and Maintaining Assurances Over Regulated Computer Systems 
$30.00
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Date/Time:
April 25, 2012   1:30pm - 2:30pm
 
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CC-1 - GLPs: The University Challenge 
$30.00
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Date/Time:
April 25, 2012   1:30pm - 2:00pm
 
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CC-2 - The Role of Universities in the Commercialization of Medical Products: A Survey of Industry Views 
$30.00
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Date/Time:
April 25, 2012   2:00pm - 2:30pm
 
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BB-2 - Driving Access: Electronic Medical Record (eMRs) Systems at Clinical Research Sites 
$30.00
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Date/Time:
April 25, 2012   2:15pm - 3:00pm
 
Format:
       
  Synched Audio / Video / Slides
 

 
Z-2 - OMG the Facility is Closing! Let's Ask QA - They'll Know What to Do with Our E-Records and Computer Systems 
$30.00
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Date/Time:
April 25, 2012   2:30pm - 3:00pm
 
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CC-3 - Let the Negotiations Begin: A Look Behind the Scenes at University-Industry Contracting Processes 
$30.00
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Date/Time:
April 25, 2012   2:30pm - 3:00pm
 
Format:
       
  Synched Audio / Video / Slides
 

 
EE-1 - QA GL 2 VICH: A Guideline to the VICH for the QA Professional 
$30.00
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Date/Time:
April 25, 2012   3:30pm - 4:00pm
 
Format:
       
  Synched Audio / Video / Slides
 

 
FF-1 - Building a Better Submission: You Can't Make it Better at the End 
$30.00
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Date/Time:
April 25, 2012   3:30pm - 4:30pm
 
Format:
       
  Synched Audio / Video / Slides
 

 
GG-1 - Quality Gates, Triggers and Patient Safety: Minimizing Risk in Risk-Based Monitoring an Auditors Perspective 
$30.00
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Date/Time:
April 25, 2012   3:30pm - 4:30pm
 
Format:
       
  Synched Audio / Video / Slides
 

 
HH-1 - The GxPs and Solo QA: Balancing Compliance 
$30.00
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Date/Time:
April 25, 2012   3:30pm - 4:30pm
 
Format:
       
  Synched Audio / Video / Slides
 

 
EE-2 - GMP Creep into GLP 
$30.00
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Date/Time:
April 25, 2012   4:00pm - 4:30pm
 
Format:
       
  Synched Audio / Video / Slides
 

 
April 26, 2012 - Thursday
 
JJ-1 - An Overview of FDA Bioresearch Monitoring Training 
$30.00
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Date/Time:
April 26, 2012   8:30am - 10:00am
 
Format:
       
  Synched Audio / Video / Slides
 

 
KK-1 - Multi-dimensional Process Mapping: One Company's Roadmap to Promoting Compliance through Effective Processes 
$30.00
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Date/Time:
April 26, 2012   8:30am - 10:00am
 
Format:
       
  Synched Audio / Video / Slides
 

 
LL-1 - What Do the Regulators Say About e-Source in Clinical Trials? 
$30.00
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Date/Time:
April 26, 2012   8:30am - 9:15am
 
Format:
       
  Synched Audio / Video / Slides
 

 
MM-1 - Ethics in Auditing for the Quality Professional and the Auditee 
$30.00
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Date/Time:
April 26, 2012   8:30am - 9:30am
 
Format:
       
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56 Results Found, Showing 1 - 50
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