This NCI SBIR PLAN Webinar Series focuses on: Implementing a Quality Management System (QMS)
A QMS is a set of procedures and practices that contribute to product quality. A QMS is used to ensure consistent production of high-quality product.
In the next PLAN webinar, prior SBIR/STTR awardees with a variety of cancer technology products such as therapeutics, diagnostics, and devices explain how they tackled various issues related to implementing a Quality Management System. As a bonus, for this topic we have additional content provided by subject matter experts from the National Institutes of Health’s Small Business Education and Entrepreneurial Development (SEED) office.
In this PLAN series, prior SBIR/STTR awardees with a variety of cancer technology products such as therapeutics, diagnostics, devices, and digital health explain how they tackled various issues related to implementing a quality management system. Please find advice videos from each panelist below.
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Medical Devices
- Watch video if interested in:
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- QMS framework
- 21 CFR Part 820, ISO 13485, FDA Division of Industry and Consumer Education (DICE)
- Building QMS objectives into SBIR/STTR applications
- QMS ownership, scaling, and alignment with regulatory requirements
- Keys to a good QMS
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- Diagnostics
- Watch video if interested in:
- Core elements of a QMS
- Determining when to implement QMS
- Using consultant services
- Integrating QMS procedures in actual working environments
- Corrective and Preventative Action (CAPA) system
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- Therapeutics
- Watch video if interested in:
- QMS considerations when acquiring a technology
- Sources of information
- COVID-related challenges
- In-house manufacturing
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- Biologic Therapeutics
- Watch video if interested in:
- Specifics for biologics
- Integration of QMS for GMP compliance
- Corrective and Preventative Action (CAPA) system
- Potency Assays
- Phase appropriate implementation of QMS
- Instituting QMS in startups
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- Small-Molecule Therapeutics
- Watch video if interested in:
- Specifics for small-molecules
- Path towards commercialization
- 21 CFR guidelines, ISO 9001:2015, ICH Q8, ICH Q9, ICH Q10
- Pillars of QMS
- Management Review
- Instituting QMS in startups
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- Medical Devices
- Watch video if interested in:
- Specifics for medical devices
- Quality system requirements
- Device Master Record, Device History Record, Design History File
- Design controls
- Risk management
- ISO 13485
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