Loading…
This event has ended. Visit the official site or create your own event on Sched.
Simple
Expanded
Grid
By Venue
Clinical Quality Track clear filter
Thursday, September 26
 

1:30pm EDT

QUALITY TRACK: Chair Opening
Thursday September 26, 2024 1:30pm - 1:45pm EDT
Speakers
avatar for Grace Crawford

Grace Crawford

Head, Clinical Operations Quality & Learning, AstraZeneca
Grace is accountable for the development, implementation, maintenance and adoption of business quality management practices and GxP learning services for BioPharma Clinical Operations, and relevant areas within R&D BioPharmaceuticals and R&D Oncology. Grace has extensive experience... Read More →
Thursday September 26, 2024 1:30pm - 1:45pm EDT
  Clinical Quality Track

1:45pm EDT

QUALITY TRACK: Quality at the Site Level
Thursday September 26, 2024 1:45pm - 2:15pm EDT
Sponsor Review of Monitoring Visits and TMF Oversight for FDA Inspections 
  • Learn successful site-specific strategies for a proactive approach to FDA inspections
  • Get an in-depth understanding of an FDA inspection and post-inspection activities for sites and sponsors
  • Gain valuable insight from a sponsor Standard Operating Procedural perspective while examining the TMF/site information to stay “inspection ready
  • Understand best practices to assure study integrity and GCP compliance
Speakers
avatar for Lella Baker

Lella Baker

Senior Consultant, GxP, Advarra
Lella Baker is a quality-minded professional with over 15 years of pharmaceutical and medical device experience. Lella has expertise in conducting vendor qualification and requalification audits, internal audits and ISA audits. She has completed regulatory filings for ADE drug safety... Read More →
Thursday September 26, 2024 1:45pm - 2:15pm EDT
  Clinical Quality Track
  • Qtag clinicalqualityfeaturedsession

2:15pm EDT

QUALITY TRACK: Panel - Drive a Quality Culture
Thursday September 26, 2024 2:15pm - 3:00pm EDT
Relate Risk-Based Quality Management (RBQM) Operational Improvements to Cultural Change and Fuel a Quality-First Organization  
  • Consider how using quality by design as a broader business objective and partnering across R&D demonstrates value of Quality to the organization 
  • Explore the shift in the RBQM era that affects the ways of working and innovating from analytics and AI to vendor oversight and management 
  • Manage the operational complexity of acquisitions happening across the industry impacting the processes, people, technologies, and external stakeholders 
  • Discuss the change management approaches used to navigate the emotional engagement and upskilling needed to bring people to the next level 

Moderators
avatar for Paul Houri

Paul Houri

Senior Vice President, Chief Quality Officer, Bristol Myers Squibb
Speakers
avatar for Sheri Kuss

Sheri Kuss

Sr. Director, GCP Quality Vaccines Category Head, Pfizer
A clinical research professional with over 20 years of GCP experience including FDA inspection preparation and facilitation, FDA Warning Letter remediation plan development, quality and compliance assessment, project management, auditing, process and SOP development, monitoring, training... Read More →
avatar for Jennifer Krohn, MS, CCRP

Jennifer Krohn, MS, CCRP

Associate Director, RBQM, Clinical Operations, Gilead Sciences
I have over 10 years of experience in leading and overseeing the centralized statistical monitoring and risk-based quality management (RBQM) of clinical trials. My mission is to ensure the quality, safety, and efficiency of clinical data and operations, and to support the delivery... Read More →
avatar for Grace Crawford

Grace Crawford

Head, Clinical Operations Quality & Learning, AstraZeneca
Grace is accountable for the development, implementation, maintenance and adoption of business quality management practices and GxP learning services for BioPharma Clinical Operations, and relevant areas within R&D BioPharmaceuticals and R&D Oncology. Grace has extensive experience... Read More →
Thursday September 26, 2024 2:15pm - 3:00pm EDT
  Clinical Quality Track
  • Qtag clinicalqualityfeaturedsession

3:30pm EDT

QUALITY TRACK: QA Competency
Thursday September 26, 2024 3:30pm - 4:00pm EDT
The Astellas-CSU PharmD Industry Rotation Partnership
  • Learn about Astellas’ recent experience welcoming Chicago State University PharmD candidates for rotations in Quality Assurance
  • Understand the benefits for both students and Astellas of this collaboration, and what other biopharma companies can take away from these learnings to initiate their own partnerships

Speakers
avatar for John Bolling

John Bolling

Director, Clinical Quality Assurance, Astellas Pharma US
John leads a team of global Asset Quality Leads in GCP with Astellas. He started his career 'on the bench', then managed laboratories before shifting to Quality Assurance for the lab/preclinical space (GLP). He has 20 years of QA experience and has been with Astellas for 11 years... Read More →
Thursday September 26, 2024 3:30pm - 4:00pm EDT
  Clinical Quality Track
  • Qtag clinicalqualityfeaturedsession

4:00pm EDT

QUALITY TRACK: Panel - GCP Inspection Readiness
Thursday September 26, 2024 4:00pm - 4:45pm EDT
Navigate the New Normal of Inspection Readiness and Create a Roadmap for Compliance  
    • Review how GCP inspections have changed post-COVID 
    • Share best practices for working with partners to ensure inspection readiness  
    • Understand the practical insights and tools to conduct thorough clinical quality due diligence during and after M&A transactions 
    • Evaluate needed resources and strategies for best leveraging them to ensure your study is inspection- prepared  
Moderators
avatar for Priya Annamalai

Priya Annamalai

Director, Inspection Program – Quality Operations, Quality Assurance, Astellas
My professional career spans across various QA and compliance roles within the pharmaceutical industry with responsibilities in the areas of Quality Systems/CAPA management, regulatory intelligence, product complaints, pharmacovigilance and most recently, leading global regulatory... Read More →
Speakers
avatar for Matthew Burtt

Matthew Burtt

Senior Director, Internal Audits & Inspections, AbbVie
Matt leads a diverse, cross-disciplinary team of Quality Professionals, delivering strong internal Quality Oversight via risk-based audit programs, and developing key insights that enable real-time inspection preparation by Inspection Management team members also under his stewardship... Read More →
avatar for Priya Chaturvedi, Ph.D.

Priya Chaturvedi, Ph.D.

Vice President, Head of Global Clinical Quality, Eisai
Priya Chaturvedi is Vice President, Head of Global Clinical Quality at Eisai Inc. She has responsibility for Global Clinical Quality Assurance, Clinical Quality Management and Global Process and Standards. She joined Eisai in 2019. Prior to that, she was Executive Director, CQA at... Read More →
avatar for Mary MacDonald, MS, RQAP-GCP

Mary MacDonald, MS, RQAP-GCP

Head of Clinical Quality Assurance, Neuroscience, Takeda
Mary MacDonald is the Head of Clinical Quality Assurance, Neuroscience. In this role she partners with the Neuroscience Therapeutic Area Unit and additional quality and research and development business partners to ensure compliance and inspection readiness for all Takeda clinical... Read More →
Thursday September 26, 2024 4:00pm - 4:45pm EDT
  Clinical Quality Track
  • Qtag clinicalqualityfeaturedsession
 
Share Modal

Share this link via

Or copy link

Filter sessions
Apply filters to sessions.
Wednesday, September 25
Thursday, September 26
Friday, September 27
  • Clinical Operations Track
  • Clinical Quality Track
  • DCT & Technology Track
  • General Session
  • Networking
  • Operations & Quality Track
  • Workshop