At Solaris SRB, we want new and existing partners to have all of the tools and accessibility needed for continuous training and education relating to FDA Compliance. Below, you can find some of our own presentations that we provide to our client base. If you wish to view the entire presentation, there is a “download” button for most versions. if you would like a detailed presentation from us, simply click “contact us” below to schedule a meeting!
fundamentals of design controls
Key Requirements and Considerations when developing and/or changing your medical device according to FDA 21 CFR Part 820 Regulations
CORRECTIVE AND PREVENTIVE ACTION
This presentation is a high level look at CAPA Processes related to regulatory and quality considerations within a GMP environment. Given the complexity and detail of this, we do not have a downloadable version. If you would like a detailed presentation of this, please contact us!
This presentation highlights important factors when developing marketing materials for a variety of FDA regulated products, including those regulated under Section 361 of the Public Health Service Act (HCT/Ps)
marketing best practices: hCT/P AND BEYOND
“Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular Tissue Based Products (HCT/Ps)”
August 2007 (current) vs. 2025 Proposal (comment period)
Currently, the FDA’s guidance document “Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” is in its comment period, where the public can provide feedback on the proposals. Here is the overview between August 2007 (current iteration) and the 2025 proposal.
(February 13,2025)
