Search results for " regulatory"
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Additional benefits will be providing a way to upskill the workforce and to focus on regulatory concerns, such as model validation and change management. Results and the white paper are due to be rele…
Article
Webinar On Demand: Expanding SPR Uses in Antibody Effector Function Determination
Critical quality attributes (CQAs) are fundamental to regulatory compliance. CQAs typically include data on how the candidate interacts with target proteins, as well as process-related CQAs such as pr…
Article
Supply Chain Challenges for Single-Use Systems
…irector of Life Sciences at Entegris; and Helene Pora, vice-president of Technical Communication and Regulatory Strategy at Pall about some of the issues facing the industry as companies look to SUS …
Resource
Plasma Product Biotechnology Conference
The sessions, compiled from submitted presentations, will cover the areas of manufacturing, quality, regulatory, pathogen safety, clinical development and technical innovations, and will chaired by re…
Article
Miniaturization to Become Even More Successful
Industrial bioprocess development has changed significantly in the last decade, driven primarily by two major factors: ever-rising R&D costs of developing therapeutic candidates with simultaneous de…
Article
Understanding Validation and Technical Transfer, Part 2
Development, process engineering, production, and regulatory affairs departments should almost always be involved. Other departments that might have input are purchasing, warehousing, and compliance. …
Article
CoAs Help Secure the Supply Chain
Schniepp, distinguished fellow at Regulatory Compliance Associates
Damian Palus/Shutterstock.com
Q. I work in the warehouse and am responsible for maintaining the pape…
Article
Modern Manufacturing Key to More Effective Vaccines
To keep pace with accelerated clinical testing of potential Ebola preventives, FDA collaborated with other regulatory authorities and WHO to gain convergence on key issues, such as exceptions to produ…
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
This is based on a supply chain that can deliver these new products to customers following regulatory approvals and in the committed timeframe.
As RRs develop, they remain centered around four k…
Article
Prepare for an FDA Bioburden Inspection
Even with effective prevention, bioburden incidents can occur. A best-practices response will not only help you be prepared for any upcoming FDA inspection, it may also yield valuable insights to help…