Donor Screening: The Case of Rabies Transmission
Today’s blog highlights a recent rabies transmission case and associated CDC recommendations
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
In our lastest blog, we outline the recent guidance from FDA on the use of real world evidence to support medical device regulatory decisions.
Biosimilar and Interchangeable Biosimilar Products – Considerations for Promotional Labeling and Marketing
Biosimilars- Regulatory considerations and overview for promotional materials!
I SOoooo Want to know More About ISO/IEC 27002:2022 for Information Security,Cybersecurity and Privacy Protection (part 2)
In Part 2 of our returning, “I SOooo Want To Know” series of blogs, we dive into ISO 27002:2022!
Extra! Extra! Read All About the AATB Updates!
There’s been a large amount of new developments with the AATB. Learn more from our lates blog here!
Chorioamnionitis in Birth Tissue Donation
Chorioamnionitis presents a great challenge in the tissue banking industry. Learn more about this infection, and the best practices to safeguard recipient health in our latest blog.
Back to Basics: Informed Consent
Learn more about informed consent with relation to tissue banking, and its importance in our latest blog!
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies
Learn more about the latest FDA Guidance, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies” now open to the public for comment.
I SOOOO WANT TO KNOW ISO/IEC 27001 for Information Security, Cybersecurity and Privacy Protection
Check out our latest blog on ISO 27001!
The Relationship with Our “X’s”: Good Clinical Practice – One of the “X’s” in GXP
Our latest blog covers Good Clinical Practices and the recent guidance: E6(R3) Good Clinical Practice, Guidance for Industry. Learn the global role of the International Council for Harmonisation (ICH) and where they fit into this topic!
Moving from Manual Systems – Automation in Progress for Tissue Bank Establishments
Is your organization seeking to modernize and implement ERP Systems? This blog covers the transition from manual systems with regard to Tissue Bank Establishments
Computer Software Assurance for Production and Quality System Software
Today’s blog covers key points on the approach an establishment should take with regard to validation and assurance of software used in medical device production and quality systems.
The Critical Role of Donor Eligibility Determination – Safeguarding Recipients
Today’s blog post covers Donor Eligibility Requirements, guided by FDA and AATB regulations, to safeguard recipients and transform lives
Navigating Medical Device Manufacturing – 510(k), PMA, De Novo, Oh My!
Learn all about Medical Device Manufacturing in today’s blog!
Introduction to the Basics of the Biologics License Application (BLA) Process
Today’s blog covers the phases and process of Biologics License Application (BLA).
Complete Response Letters – When Your Submission Application Isn’t Granted
The latest blog covers Complete Response Letters and the recent publication that FDA has released.
Training: The Critical Role in Tissue Banking
Our newest blog covers the importance of training in tissue banking, and how to refine your process!
Quality Agreements – The Robust Cornerstone of Tissue Safety and Compliance
Our newest blog covers Quality Agreements! What are they?, what are the benefits, and how to build an effective Quality Agreement
Machine Learning: The Era of Artificial Intelligence in Our Industry – 101
Today’s blog provides the basics of understanding Artificial Intelligence in the Life Sciences Industry