Learn from a team of leading QA experts

Chris St Amour

Christy Mazzarisi

Dawn Niccum

Maria Veleva

The Building Block Approach to QMS Development in Scaling BioPharma
Dive into the essentials of creating a Quality Management System (QMS) that grows with your biopharma startup. Learn how to piece together the right QMS for your needs, ensuring scalability and fit, as well as what type of eQMS platform to choose to help you level up.



Core Strength: Crafting Fundamental SOPs and Baseline Processes Within Your QMS Routine
Strengthen your QMS core with fundamental SOPs and processes tailored for your company's success. This session empowers you to identify and implement the essential procedures your startup needs, without overcomplicating things. Learn how to perform gap analyses and process audits like a pro, setting the stage for a streamlined and efficient operational blueprint.



Role Call: Starting Strong with Role-Based Training in QMS
Kickstart your QMS with role-based training that ensures every team member hits the ground running. Discover how to design a training program and matrix that perfectly fits your team's needs and growth trajectory. In this session, we'll guide you through creating a training strategy that's just right, avoiding the pitfalls of scaling up too late.



Process Strains & Growing Pains: Simplifying Quality Events, CAPAs and Change Controls
Navigate the complexities of quality events and change controls with confidence. This session covers the A to Z of building foundational processes for managing CAPAs, quality events, and change controls, ensuring your QMS is resilient and responsive. Learn how to turn growing pains into growth gains, making your quality processes a beacon of reliability.



Supply Chain Shape-Up: Jumping into Risk-Based Supplier Management
Leap into the world of risk-based supplier management and master vendor qualification and audit management. This session focuses on strategic supplier management, equipping you with the tools to build a process that is risk-based from the outset.



Quality Gains: The Power of Continuous Improvement in Your QMS Health Regimen
Embrace the journey of continuous improvement to elevate your QMS to peak performance. This final session delves into the importance of metrics, KPIs, and a closed-loop approach to quality. Discover how to harness the power of ongoing enhancement to not just meet, but exceed your quality goals.


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