Quality by Design for Outsourced Operations: A Practical Guide for Sponsor Oversight  

This webinar will unpack the essential compliance challenges facing today’s virtual and hybrid pharmaceutical companies and provide a clear roadmap for mitigating risk across outsourced GXP operations. Attendees will learn how to establish a right-sized Quality Management System (QMS), apply a risk-based vendor qualification strategy, and implement effective oversight mechanisms to ensure transparency, data integrity, and regulatory compliance across CMOs, CDMOs, CROs, testing laboratories and other contracted partners. We will also explore how to strengthen quality agreements, optimize change management across multiple vendors, and leverage cloud-based systems to enhance real-time communication with contractors. By the end of the webinar, participants will walk away with actionable strategies to safeguard product quality and patient safety and understand why the buck stops with the sponsor. 

Key Learning Objectives:  

• Right‑sized Quality Systems Are Essential 
  Virtual and hybrid pharma companies must implement an appropriately scaled QMS and apply risk‑based vendor qualification to manage outsourced GXP activities effectively. 

• Strong Oversight of External Partners Is Critical 
  Sponsors need robust oversight mechanisms to ensure transparency, data integrity, and compliance across CMOs, CDMOs, CROs, labs, and other contracted partners. 

• Quality Agreements and Change Management Must Be Strengthened 
  Effective, detailed quality agreements and coordinated change‑management processes are necessary to align multiple vendors and maintain control over contracted operations. 

• Technology Can Enhance Control and Communication 
  Cloud‑based systems enable real‑time communication and oversight, helping sponsors reduce risk and safeguard product quality and patient safety—reinforcing that ultimate responsibility remains with the sponsor. 

Who Should Watch:  

Regulatory Affairs Professionals,  

Quality Assurance (QA) Professionals, 

Operations & CMC Leaders,

Startup Biotechs & Emerging Pharma Executives,

Julie Burnhill, PhD, Senior Consultant, Regulatory Affairs 

Julie Barnhill, PhD, is a Senior Consultant with Pace® Life Sciences, specializing in guiding pharmaceutical organizations through the complexities of GXP compliance from preclinical development through commercial stages of drug development. She provides strategic QA leadership to a diverse portfolio of clients, including virtual biopharma companies with fully outsourced operations, emerging clinical-stage organizations, and established commercial companies. Dr. Barnhill has extensive experience helping companies build compliant quality systems, performs GXP audits on their behalf, and helps prepare companies for FDA inspections. 

Before joining Pace®, Dr. Barnhill served in several senior leadership roles, including Head of Quality at Osiris Therapeutics, Head of QA Compliance at Alpharma (now Actavis), and Director of Quality Control and Analytical Development at Chesapeake Biological Laboratories (now Emergent). Her career has focused on ensuring the quality of parenteral drug products, with additional expertise in inhalation, nasal, and oral medicines. 

A recognized industry expert, Dr. Barnhill serves on the Board of the PDA Capital Area Chapter and has held academic appointments as Adjunct Graduate Faculty in Biotechnology and Regulatory Affairs at Johns Hopkins University. She is also a Course Director with the Center for Professional Innovation and Education (CfPIE).