ExL’s 11th Proactive GCP Compliance
The Avoca Group is pleased to participate in ExL’s 11th Proactive GCP Compliance conference, March 16-18, 2020, in Philadelphia, PA. Participants will learn how to effectively build quality risk management approaches into clinical operations to optimize research, maintain GCP compliance, contain costs, and ensure patient safety.
15% Discount Code: 786020AVOCA
Please join us for the following session:
Wednesday, March 18 | 11:30am – 12:15pm
Track A – QUALITY BY DESIGN
Review Quality by Design and Proactive Quality Management As a Vehicle for Clinical Trial Modernization and ICH E8 (R1) Compliance
- Discuss Section 3 of ICH E8 (R1) focusing on proactive quality by design, including:
- Identify and manage critical-to-quality factors (CTQs)
- Establish and nurture a quality culture
- Incorporate stakeholder feedback (including patient and caregiver) into trial design
- Evaluate how the above factors can have a positive effect on quality outcomes for the trial
Executive Director, Client Delivery
The Avoca Group
As leader of the Avoca Group’s Integrated Consulting and overseer of the Avoca Quality Consortium workstreams, Crissy MacDonald provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across The Avoca Group. Crissy has 12 years of pharmaceutical industry experience with expertise in clinical research, process development, and strategic management. Crissy earned a PhD in biomedical engineering from Drexel University and a bachelor’s degree from Lafayette College.