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Programme Titles Presenters 
Saturday, 5 April 2014
3:00 - 6:00 PM  Registration Open
Gracia Ballroom Foyer
 
Sunday, 6 April 2014 - QUALITY COLLEGE
  All programs will be held at the Cosmopolitan of Las Vegas. Separate registration is required for Quality College courses on Sunday.
7:00 AM - 5:00 PM  Registration Open
Gracia Ballroom Foyer - Third Floor
8:00 AM - 5:00 PM  1: Basic Training Good Laboratory Practices
Condesa 1
  2: Good Clinical Practice: The Basics
Condesa 2
  3: Basic Concepts in Computer Validation
Condesa 4
  4: Developing a GLP-Compliant Program in a University Setting
Condesa 5
  5: Managing GLP Multisite Studies in Accordance with OECD Monograph No. 13
Condesa 6
  6: Animal Health: The Basics and Beyond
Condesa 7
  7: Pharmacovigilance Audits
Condesa 8
8:00 AM - 12:00 PM  8: QA Consulting 101
Condesa 9
1:00 - 5:00 PM  9: SQA Leadership Development
Condesa 9
 
Monday, 7 April 2014 - QUALITY COLLEGE
  All programs will be held at the Cosmopolitan of Las Vegas. Separate registration is required for Quality College courses on Monday.
7:00 AM - 6:00 PM  Registration Open
Gracia Ballroom Foyer - Third Floor
8:00 AM - 5:00 PM  1: Basic Training: Good Laboratory Practice (continued)
Condesa 1
  2: Good Clinical Practice: The Basics (continued)
Condesa 2
  3: Basic Concepts in Computer Validation (continued)
Condesa 4
  4: Developing a GLP-Compliant Program in a University Setting (continued)
Condesa 5
  10: Archiving 201: Beyond a GLP-Compliant Archiving Function
Condesa 6
8:00 AM - 12:00 PM  11: Electronic Data Capture and Animal Health
Condesa 7
1:00 - 5:00 PM  12: The FDA Is Coming to Your Veterinary Clinical Site: Don't Panic, Prepare!
Condesa 7
8:00 AM - 5:00 PM  13: Problem Definition Through CAPA Effectiveness: Across GxPs
Condesa 8
  14: New Perspectives in QA - Tools, Techniques and Strategies for Enhancing Effectiveness and Enjoyment
Condesa 9
5:30 - 7:00 PM  Global Conference Opening Reception
North Boulevard Pool
 
Tuesday, 8 April 2014 - CONFERENCE
  All programs will be held at the Cosmopolitan of Las Vegas.
7:30 AM - 5:00 PM  Registration Open
Gracia Ballroom Foyer - Third Floor
  Network with Exhibitors
Gracia Ballroom
7:30 - 8:30 AM  Continental Breakfast with the Exhibitors and Posters
Gracia Ballroom
8:30 - 10:00 AM  Opening Plenary
Brera Ballroom
10:00 - 10:30 AM  Beverage Break with Exhibitors and Posters
Gracia Ballroom
10:30 AM - 12:00 PM  Session A
A-1 Are there pitfalls with process-based inspections?
A-3 Responding to FDA 483 Observations – Approaches to providing responses to 483 observations

Brera 1-3
  Session B
B-1 The Global Guideline for GCP Audit and Appendices

Brera 4-6
  Session C
C-1 Introduction to Workflow, Advantages, Disadvantages
C-2 Workflow Management Case Study: ELN and Controlling Electronic Forms
C-3 Workflow Management Case Study: CAPA and SOP Approval

Castellana 2
  Session D
D-1 Large Molecule Analysis in a Small Molecule World: Things to Look for When the Guidelines Don’t Provide Much Guidance
D-2 Necessary Information Transfer from the Clinic or Test Facility to the Bioanalytical Laboratory
D-3 Auditing: What Can We Learn From Soccer?

Castellana 1
  Session E
E-1 Implementing Good Practice in the Use of Computer Prediction
E-2 Jazz Audits – a freeform fusion of auditing advances to free the mind of the auditor
E-3 Quality of NonGLP Studies

Condesa 4
12:00 - 1:30 PM  Networking Lunch
Gracia Ballroom
1:30 - 3:00 PM  Session F
F-1 Implementation of SEND (Standard for Exchange of Nonclinical Data)

Brera 1-3
  Session G
G-1 A case study of a sponsor’s design, implementation, and management of an international, risk-based quality oversight program.
G-2 UTMB and FDA Education Collaboration: Achieving Data Quality and Integrity in Maximum Containment Laboratories

Brera 4-6
  Session H
H-1 Open Mic with CVIC

Castellana 2
  Session I
I-1 SQA Rapid Response and US Perspective on the Draft FDA Bioanalytical Method Validation Guidance

Castellana 1
  Session J
J-1 Understanding GxP in Today's China: The Current Status of Implementing CFDA regulations GLP In China
J-2 Understanding GxP in Today's China: GMPs in China – Through the Eyes of a U.S. Quality Professional
J-3 Understanding GxP in Today's China: The Evolution and Application of GCP Principles in China – A Perspective

Condesa 4
3:00 - 3:30 PM  Snack and Beverage Break with Exhibitors and Posters
Gracia Ballroom
  Poster Session
Gracia Ballroom and Commons
3:30 - 5:00 PM  Session K
K-1 The Ever Evolving World of Animal Welfare: Managing the Challenging Regulatory Environment

Brera 1-3
  Session L
L-1 Clinical Oversight: Be VERY Sure
L-2 Overcoming Death by CAPA: Closing Your Quality Loops
L-3 Embedding Quality into Your Clinical Trials

Brera 4-6
  Session M
M-1 CSV for the Clinical Auditor - Auditing the Clinical Data Functions
M-2 Another Paradigm Shift: Remote Investigator Site Auditing
M-3 Traceability: The Key To Navigating, Understanding, and Believing Validation Documentation

Castellana 2
  Session N
N-1 Current Issues in Bioanalytical Method Validation and Study Operations – Test Facility Perspectives
N-2 Recent Veterinary GCP and University GLP Regulatory Inspectional Experiences: A Comparison of Perceptions from Site Qualification to Site inspection
N-3 Recent Activity – FDA-CVM Perspectives on Current Challenges, Concerns and Successes

Castellana 1
  Session O
O-1 International Etiquette: What You Think You Know (But Do Not Actually Know) About Global Business Culture
O-2 To Increase SOP Compliance Rate through Combining Chinese Traditional Culture with GLP Guideline

Condesa 4
5:00 - 6:30 PM  Peripheral Meetings
Various rooms
6:30 - 8:00 PM  International Networking Reception
Mont-Royal 2 - Fourth Floor
 
Wednesday, 9 April 2014 - CONFERENCE
  All programs will be held at the Cosmopolitan of Las Vegas.
7:30 AM - 5:00 PM  Registration Open
Gracia Ballroom Foyer - Third Floor
7:30 AM - 3:30 PM  Network with Exhibitors
Gracia Ballroom
7:30 - 8:30 AM  Continental Breakfast with the Exhibitors and Posters
Gracia Ballroom
8:30 - 10:00 AM  International Regulatory Plenary Session
Brera Ballroom
10:00 - 10:30 AM  Beverage Break with Posters and Exhibitors
Gracia
10:30 AM - 12:00 PM  Session P
P-1 GLP World Cup - Initial Rounds

Brera 1-3
  Session Q
Q-1 Understanding the Similarities and Differences between ISO-Based and GxP Quality Systems
Q-2 The Power of Patterns – An Analysis of Audit Scenarios
Q-3 Common and Uncommon GLP Dilemmas: Resolution Mentoring

Brera 4-6
  Session R
R-1 Clinically Significant - Using EMR systems in Clinical Research

Castellana 2
  Session S
S-1 A GMP Auditor Lost In a USP <797> World: A Look at US Phase I Unit Pharmacies

Castellana 1
  Session T
T-1 CVIC/GLPSS/SASS joint panel discussion: Archiving Electronic Records

Condesa 4
  Session U
U-1 Leveraging the Auditor’s Greatest Tool

Condesa 3
12:00 - 1:30 PM  Networking Lunch
Gracia Ballroom
1:30 - 3:00 PM  Session P (continued)
P-2 GLP World Cup - Final Rounds

Brera 1-3
  Session V
V-1 Japanese PV Regulation Update
V-2 Pharmacovigilance Audits - A Pivotal link in Drug Safety

Brera 4-6
  Session W
W-1 Door 1, 2, or 3? Don’t Get Zonked on Cloud Data Centers

Castellana 2
  Session X
X-1 Scientific Misconduct HAPPENS!
X-2 Risk based Monitoring, an European View
X-3 Risk-based quality management of clinical trials – What is special about the concept?

Castellana 1
  Session Y
Y-1 Legal Implications of Non-Compliance
Y-3 Sample Preparation of Medical Devices for Biocompatibility Testing

Condesa 4
  Session Z
Z-1 Interviewing Techniques - The good, the bad and the many different ways!

Condesa 3
3:00 - 3:30 PM  Snack and Beverage Break with Exhibitors and Posters
Gracia Ballroom
3:30 - 5:00 PM  Session P (continued)
P-3 GLP World Cup - In Review

Brera 1-3
  Session AA
AA-1 Bioanalytical Guidance and Global Impact Part I - Overview of Brazil’s ANVISA Guidance and Japan’s Guidance
AA-2 Bioanalytical Guidance and Global Impact Part II – Similarities, Disparities and Disagreements FDA vs EMA
AA-3 Bioanalytical Guidance and Global Impact Part III – Similarities, Disparities and Disagreements FDA vs ISO

Brera 4-6
  Session BB
BB-1 Audit vs. Qualification of Technology Providers
BB-2 Digital Imaging – Validation for Use in a Regulated Environment
BB-3 Software Vendor Auditing – Practical Experience, Implications, Challenges

Castellana 2
  Session CC
CC-1 Independent Institutional Review Board Audits: A Typical Vendor Audit or Not?
CC-2 IRB Audits - Why do them?
CC-3 Impact and Challenges of a Quality Management System on IITs in Switzerland

Castellana 1
  Session DD
DD-1 Quality collaborations across institutions, countries and cultures
DD-2 Training the next generation of research scientists to use principles of Quality Assurance to safeguard data integrity.
DD-3 Establishment of a Global External Quality Assurance Program for HIV-1 Immune Monitoring Laboratories

Condesa 4
  Session EE
EE-1 Process Improvement Methodolgies Roundtable, Including Lean 6 Sigma

Condesa 3
5:00 - 6:00 PM  Peripheral Meetings
Various rooms
6:30 - 10:00 pm  Elton John Show
 
Thursday, 10 April 2014 - CONFERENCE
  All programs will be held at the Cosmopolitan of Las Vegas.
7:30 AM - 3:30 PM  Registration Open
Gracia Ballroom Foyer - Third Floor
7:30 - 8:30 AM  Continental Breakfast
Gracia Ballroom
8:30 - 10:00 AM  Session FF
FF-1 Compliant Use of Cloud Technology in the Life Science Industry
FF-2 Agile Software Development: Will It Pass the QA Sniff Test?
FF-3 Testing and Validation of Mobile Apps, in a BYOD world for Regulated Applications

Brera 1-3
  Session GG
GG-1 The Electronic Audit Management System - Justification, Selection, Implementation, Validation, and Administration of an Electronic Audit Management System (eAMS)

Brera 4-6
  Session HH
HH-1 Audit Findings: How to write and support effective findings
HH-2 Mitigating Risk when utilizing non-GLP facilities in GLP studies
HH-3 Partnership in Adopting a Quality Systems Approach within a Clinical Services Strategic Resourcing Venture

Castellana 2
  Session II
II-1 Disaster Countermeasures in Laboratories in Japan - Based on the Experiences of Disasters Including the Great East Japan Earthquake -
II-2 How to Successfully Manage a Foreign Regulatory Agency Inspection
II-3 Creating Effective and Efficient Quality Systems in Government Funded International Clinical Networks – The Clinical Pharmacology Quality Assurance and Quality Control Program

Castellana 1
  Session JJ
JJ-1 Overview of FDA Regulatory Requirements for Medical Device Combination Product Development
JJ-2 QA and QC in GLP Facilities
JJ-3 Multi-site Study Phases In Compliance With GLP – Planning, Conducting and Reporting By A Test Site

Condesa 4
  Session KK
KK-1 Harmonization of global quality standards relevant to the Animal Health industry – its impact on global sponsors

Condesa 3
10:00 - 10:30 AM  Beverage Break
Gracia Ballroom
10:30 AM - 12:00 PM  Regulatory Outlook Part I
Brera Ballroom
12:00 - 1:00 PM  Networking Lunch
Gracia Ballroom
1:00 - 3:30 PM  Regulatory Outlook Part II and Q&A Panel
Brera Ballroom
 
Friday, 11 April 2014 - QUALITY COLLEGE
  All programs will be held at the Cosmopolitan of Las Vegas. Separate registration is required for Quality College courses on Friday.
7:00 AM - 5:00 PM  Registration Open
Gracia Ballroom Foyer - Third Floor
8:00 AM - 5:00 PM  15: Current Topics in Good Laboratory Practice
Condesa 1
  16: Good Clincial Practice: Beyond the Basics
Condesa 2
  17: Advanced Topics Related to Medical Device Studies
Condesa 4
  18: Hosting Client Audits in the GxP Environment
Condesa 5
  19: Good Practices: Understanding the GxP Regulations Using a Quality System Approach
Condesa 6
  20: QA Professional Fundamentals 101
Condesa 7