Abstract Submission

The SQA Program Committee invited submission on all regulatory QA topics for presentation: clincal (GCPs), preclinical (GLPs) and manufacturing (GMPs). The Committee welcomed abstracts on other areas of interest as well, including animal health, bioanalysis, biotechnology, computer validation, medical devices, pharmacovigilance, scientific archiving, university issues and much more. All presenting authors of abstracts accepted for presentation are required to register for the conference and pay the appropriate fees, in accordance with the published fee schedule. All abstracts will be published in the Conference Program Book. Abstracts will be accepted for posters, 30 minute podium presentations, 90 minute panel discussions and 90 minute roundtable sessions.

Notifications have been made to all authors of submitted abstracts. If you did not receive a notification, please contact sqa@sqa.org.

Abstracts were accepted on the following "hot topics."

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  1. Beyond Compliance
    • Lean Six Sigma
    • Back to Basics in Quality Management Systems
    • Using Continuous Improvement Techniques
    • Establishing the Ethical Cultural for the QA Professional
    • Soft Skills: Cultural Attitudes during Audits
    • Soft Skills: Collaboration with Stakeholders
    • Soft Skills: Communicating with Your Internal Business Groups
    • Tools: Metrics, What Really Matter!
    • Tools: Root Cause Analysis -- Case Study (Globally)
    • Soft Skills: Navigating Regulatory and Reference Websites when They Continue to Change
    • Soft Skills: The ABCs of GxPs
  2. Computer Validation
    • Testing Applications for Security Threats
    • Electronic Medical Records: Verification, Validation and Compliance
    • Demystifying Regulated Computer Validation for the CRA
    • How to Qualify a Cloud Vendor
    • Why Validate? A Review of Recent Warning Letters
    • Periodic Evaluation of Validated Systems
    • Qualification Criteria for Data Centers
    • Compliant Electronic and Digital Signature
    • Validation Strategy for Mobile Apps
    • iValidation and The Future of Compliance
    • Agile Development and Software Validation
    • To Validate or Not to Validate?
    • Audit Criteria for Software Validation
    • IT Tools for Knowledge Management to Support QA
  3. Good Clinical Practice
    • MHRA GCP Guide: How Does it Compare with FDA Guidance?
    • All New EU Clinical Trial Regulation: What's the Impact?
    • GCP Requirements for Medical Device Clinical Studies
    • The Global Guideline for GCP Audit and Appendices, SQA/RQA/JSQA Global Guideline for GCP Audit: Overview of Joint Project
    • Grading of Audit Findings, CRO Audits, IRB/IEC Audits by JSQA
    • CAPA, Investigator Site Audits, EMR Audits, Laboratory Audits
    • Risk Based Approach, EDC/DM vendor Audits, IRT Vendor Audits by RQA
    • Basic research: Testing of Discovery whose Data (not GLP) are Used Directly in Clinical Studies: Efficacy Studies or Drug Interactions
    • Advantages and Benefits of an External QA
    • Pharmacovigilance (PV) Auditing
    • Postmarketing PV in US
    • Data Privacy/Protection Panel: Ways of Handling what is acceptable on CRFs, DOB, 3rd party vendor involvement, differences for different countries
    • CAPAs
    • Fraud and Misconduct (what looks like, technologies used to perpetrate F&M and how to detect)
    • Cloud Computing in Clinical Trials
    • Finding Trends and Analyzing Data/Generating Metrics
    • Electronic Source Records
    • Auditing EDC Systems
    • Auditing IRBs
    • Risk-based Monitoring/Risk-based Auditing
    • Comparison of GLP and GCP if There are Changes When New GLPs are Issued
    • GCLP
    • Overview: Difference in Global Inspections for Europe, Latin America, Africa, etc.
    • Investigator-initiated Studies and Quality's Role
  4. Good Laboratory Practice
    • FDA SEND Initiative: Provide an Update on the SEND Initiative and Discuss the Impact on Auditing of GLP Studies
    • Electronic Signatures: How do You Know it is Authentic and How Do You Archive the Record?
    • Analysis of Clinical Trial Samples: What Standards Should be Applied?
    • Influence of Handheld Devices and Other New Technology
    • Impact of Social Media
    • Archiving Electronic Records
    • Cloud Computing
    • New Biological Areas (e.g. stem cells)
    • Unique Challenges Surrounding Large Molecule Studies
    • Dried Blood Spot Analysis
    • Digital Images Management and Sharing: Processes in Place to Increase Quality
    • Driving QC into Scientific Areas
    • GMP vs. GLP for Drug Characterization/Early Development Product: What are the pitfalls in relying on "GMP" test article in a GLP study?
    • Animal Rule Studies: Do the GLP regulations apply? What is the role of the IACUC, SD, and Attending Veterinarian? Has FDA issued a guidance document on the conduct of these studies?
    • Conduct of GLP Studies in non-MAD Countries: Status of health authority acceptance of studies conducted outside the US, OECD and Japan?
    • Disaster Recovery Plan
    • Quality of non-GLP Studies
    • Asian Regional Topics
    • European GLP 25': New trends and challenges
    • Detailed Procedure for Process-based Inspection
    • How Test Sites Should Write Analysis, Plan and Report for a Multi-site Study
    • Quality Assurance in Nanomaterial Toxicity Testing
  5. Good Manufacturing Practice
    • Bench through Clinical (R&D, nonclinical GLP, clinical GCP, to final drug / device manufacturing GMP)
    • Biosimilars (Biosimilar Versions of Currently Approved Biological Products)
    • Building a GMP Quality System
    • CA /PA / OOS / OOT
    • Compounding
    • GMP in Phase 1 - EU has regulation, US does not (US has FDA's 2008 Guidance for Industry cGMP for Phase 1 Investigational Drugs)
    • ICH Q8 (Pharmaceutical Development) / Q9 (Quality Risk Management) / Q10 (Pharmaceutical Quality System) / Q11 (Development and Manufacture of Drug Substances)
    • PIC/S
    • Quality System Regulations
    • Quality by Design - Integral Process Control
    • Quality Management Systems (QMS) - ISO vs. QMS vs. drug GMP
    • Statistics (especially use of statistics in validation) and Metrics (tracking/trending)
    • Supplier Management (beginner, intermediate, advanced): Managing, Outsourcing, Auditing, Quality Agreements, etc.
    • Transitioning from Cosmetic Manufacturer to Drug Manufacturer
    • Validation Topics - Process Validation, Cleaning Validation, Electronic Batch Records
    • Warehousing/Distribution (Good Distribution Practices)
  6. Good Pharmacovigilance Practice
    • Drug Safety and Pharmacovigilance Innovation: Each Region Update
    • Good Pharmacovigilance Practice (GVP): New EU Guidelines
  7. Scientific Archiving
    • Electronic Archiving
  8. University
    • Building Quality Collaborations across Service Units: Successful Strategies for Creating Effective Partnerships between QA and IT, Animal Resources, Facilities Management, Purchasing or Clinical Services
    • Developing Effective Shared Equipment Management Programs to Ensure Sound Science and/or Regulatory Compliance
    • International Quality Assurance Standards (comparisons, contrasts, consensus)
    • Building National and International Quality Assurance Networks and Collaboration