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24: Decoding GMP Supplier Oversight by Applying QRM with Confidence
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In this episode, we're decoding what effective GMP supplier oversight really looks like—and how sponsors can apply Quality Risk Management (QRM) principles to build smarter, more sustainable programs. We will cover supplier oversight, ongoing performance monitoring, and risk-based decision-making, with practical insights and a focus on what matters most: protecting product quality and patient safety.
Whether you’re building a supplier oversight program from the ground up or refining what’s already in place, this episode delivers the tools and mindset shifts sponsors need to lead with intention and compliance.
This month's guest is Rosanna Bules, a Certified Quality Auditor. Rosanna is a strategic and results-driven Quality Assurance Leader with 17+ years of biopharmaceutical experience (commercial and clinical), specializing in GMP Supplier Quality Management (SQM), audits, regulatory compliance, and risk-based quality oversight. Expertise in developing risk-based programs, conducting domestic and international audits, establishing and negotiating quality technical agreements (QTAs), and fostering cross-functional collaboration to ensure compliance with global regulations/guidelines. Proven track record in designing/developing processes, improving/streamlining existing processes, leading teams, and delivering measurable improvements in supplier oversight and management.
This month’s show notes include:
Whether you’re building a supplier oversight program from the ground up or refining what’s already in place, this episode delivers the tools and mindset shifts sponsors need to lead with intention and compliance.
This month's guest is Rosanna Bules, a Certified Quality Auditor. Rosanna is a strategic and results-driven Quality Assurance Leader with 17+ years of biopharmaceutical experience (commercial and clinical), specializing in GMP Supplier Quality Management (SQM), audits, regulatory compliance, and risk-based quality oversight. Expertise in developing risk-based programs, conducting domestic and international audits, establishing and negotiating quality technical agreements (QTAs), and fostering cross-functional collaboration to ensure compliance with global regulations/guidelines. Proven track record in designing/developing processes, improving/streamlining existing processes, leading teams, and delivering measurable improvements in supplier oversight and management.
This month’s show notes include:
- Link to Integrating Knowledge Management into QMS for Early Stage Companies: A Practical Approach for Improved Business Performance and Growth, Part 1
- Link to Integrating Knowledge Management into QMS for Early Stage Companies: A Practical Approach for Improved Business Performance and Growth, Part 2
- Link to FDA Chapter 56 Drug Quality Assurance: Outsourcing Facility Inspections
- Link to Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
- Link to FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements
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