1. The Changing Face of Clinical Compliance: Regulatory, Technology, and Services SIAC Overview
Track 11 Symposium
27 June 2012
1:30 – 3:00 PM
Chairperson: Penelope Przekop, MSc

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3. Key Messages
Face of clinical compliance is changing based on regulatory and technological advances.
QA professionals are key to ensuring that industry continue to reflect current regulations and protect patient safety.

4. Presenters Regulatory Technology Services Carol Bognar, MSN, RN
QA Consultant, Carol Bognar Consulting, LLC.
Technology
Shiela McLaughlin
International Director, QA, DATATRAK International, Inc.
Services
Penelope Przekop, MSc
Senior Director, Global QA & Training, Theradex Systems, Inc.

5. Carol Bognar QA Consultant Carol Bognar Consulting, LLC
GCP Auditing Implications related to the FDA Guidance on Risk-Based Approach to Monitoring
Carol Bognar
QA Consultant
Carol Bognar Consulting, LLC

6. Introduction Risk-based industry FDA Guidance risk-based monitoring
EMA Reflection paper on risk-based quality management in clinical trials
Clinical Trial Transformation Initiative (CTTI)
Auditing Implications / Case Studies

7. FDA / EMA
Draft EMA Reflection Paper on Risk-Based Quality Management in Clinical Trials (August 2011)
Draft FDA Guidance for Industry – Oversight of Clinical Investigations – A risk-based approach to monitoring (August 2011)

8. QA Auditing Implications
Will audits become obsolete in this new environment ?
Will auditing change?
Will auditors be required to change?

9. The Role of Quality Assurance in eClinical Environments – When to Dive in
Shiela McLaughlin
International Director Quality Assurance
DATATRAK, International

10. Introduction
Quality Assurance and the Software Development Lifecycle (SDLC)
Auditing your software vendor
eSource / eClinical, the FDA’s preferences

11. FDA
General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 2002)
Guidance for Industry, Electronic Source Documentation in Clinical Investigations (December 2010)

12. A Whole New World: CRO Clinical Quality Assurance
Penelope Przekop
Sr. Director, Global QA & Training
Theradex Systems, Inc.

13. Introduction Traditional CRO / Pharma relationships
CRO vs. Pharma culture
Regulatory trends
Quality systems
Outsourcing
Assessing risk
Relationship evolution

14. Quality Systems Key components in CROs and Pharma
Processes
Document Control
Training
Auditing
CAPA Management
Escalation
Issues inherent in CRO culture
Role of QA

15. CRO System Audits Identify process gaps
Support organizational efficiency
Ensure QC functions and steps exist
Ensure right people are in right roles
Provide audit / inspections readiness
Drive pro-active risk-based approach