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Peer Learning and Networking Webinar Series

The NCI SBIR Peer Learning and Networking (PLAN) Webinar Series provide an interactive forum for SBIR/STTR applicants and awardees to hear best practices from peers who have been successful within the Program. Each participating company shares expertise on a webinar topic and discusses the technology areas in which they hope to collaborate with other companies.

 

Part I. Presentation

Watch pre-recorded panelist presentation on the PLAN webpage prior to joining the webinar and write down your questions.

 

 

Part II. Panel Session

Attend real-time panel session and ask your questions to the panelist and/or the moderating NCI SBIR program director.

 

 

The upcoming NCI SBIR PLAN Webinar Series will focus on: Implementing a Quality Management System (QMS)

Webinar date: Thursday, Sep 22 2022 1:00 PM - 2:00 PM Eastern Time

 

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.  Please find advice videos from each panelist below and register for the follow up Q&A session on Thursday, September 22 at 1:00pm ET.

 

 

Medical Devices - Enspectra Health 

Watch video if interested in:

  • 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

 

Diagnostics - MagArray

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

 

Therapeutics - NuvOx Pharma

Watch video if interested in:

  • QMS considerations when acquiring a technology
  • Sources of information
  • COVID-related challenges
  • In-house manufacturing

 

Biologic Therapeutics - NIH SEED 

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

 

Small-Molecule Therapeutics - NIH SEED

 

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

 

Medical Devices - NIH SEED

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

 

To access content from previous PLAN series, click on the link below:

 

Be on the lookout for upcoming topics, including:

  • Spotlight Video: Top Takeaways on How to Set Up a Small Business
  • Keys to a Successful IND Submission
  • Spotlight Video: CARE Success Stories
  • Spotlight Video: Small Business Transition Grant (SBTG)

If you have topic suggestions for the PLAN series, please email us at ncisbir@mail.nih.gov

 

  • Updated:

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