Combination Products and Parenteral Packaging: A Notified Body (EU) Perspective
This presentation at the 2022 Nelson Labs Virtual Symposium will provide a comprehensive overview of the considerations...
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Rubber Manufacturing and Composition of Pharma Rubbers
Rubber closures are a critical component in the primary packaging system of small volume parenterals (SVPs). At...
Radiation Sterilization of SVPP: RTU and fill/finished. Do not default to 25 kGy – 40 kGy.
At the 2022 Nelson Labs Virtual Symposium, we will present examples of radiation sterilization for Ready-to-Use (RTU)...
Polymer-based, Pre-filled Syringes designed to Minimize the Aggregation Risk of Sensitive Biodrugs
Biopharmaceutical drugs offer new therapeutic solutions to numerous human diseases and conditions. However, these advanced therapies come...
Manufacturing an SVP Drug Containment Solution: Quality by Design
The 2022 Nelson Labs Virtual Symposium will offer an in-depth look at the considerations necessary when choosing,...
E&L Testing of Single-Use Systems for Production
In the 2022 Nelson Labs Virtual Symposium, this presentation will focus on the critical issue of leachables...
A Structured Approach to Selection of Container Closure Materials for Small Volume Parenterals – Pipe Dream or Necessity
In the upcoming 2022 Nelson Labs Virtual Symposium, this presentation will emphasize the importance of selecting materials...
A Stepwise Approach to Deal with In Vitro Cytotoxicity Failures
Manufacturers are required to perform a biological evaluation of any medical device as outlined in ISO 10993-1....
FDA Medical Device Inspections in the Post Pandemic World
The FDA is ramping up its inspections of medical device manufacturing facilities. Are you ready? Since March...
2022 State of the Medical Device Industry Quality, Biocompatibility, and Changing Regulations
As another year unfolds with regulatory changes, updated mandates, and the ongoing impacts of the COVID-19 pandemic,...