whitepaper
Whitepaper: Sterility testing – difficult products
This whitepaper considers sterility testing to support pharmacopoeial monographs with an emphasis on products that are difficult to test or validate.
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Medical Devices
whitepaper
Whitepaper: Implementing 21 CFR Part 11 in epMotion® software
Electronic records and electronic signatures in the regulated environment of the pharmaceutical and medical device industries.
whitepaper
Press release: Freeze drying: New Telstar Usifroid platform for retrofitting & maintenance
Telstar launches Usifroid global service platform for retrofitting & maintenance of freeze-dryers. To optimise and extend the life cycle of freeze-drying equipment from any brand or model.
video
On-demand webinar: Water systems – microbial monitoring
This webinar considers the fundamental importance of water system control within pharma processing and the best control and monitoring practices.
whitepaper
Press release: Telstar: 360 degrees GMP consultancy & engineering solutions at CPhI
Telstar promotes innovative aseptic production solutions in a setting marked by the new GMP Annex 1.
video
On-demand webinar: High speed for your material analysis
In this webinar, discover how an innovative 2-in-1 method for material analysis accelerates visual and chemical particle analysis in the pharmaceutical industry.
whitepaper
Flyer: Efficient root cause analysis of foreign particles in pharmaceutical products
This flyer explains step-by-step how to perform your root cause analysis more efficiently, reliably and cost-effectively with a 2-in-1 solution for visual and chemical particle analysis.
article
Maintaining EU MDR certification: a spotlight on post‑market clinical follow-up
Celeste Maksim, Chief of Staff, Clinical and Post-Market Practice, RQM+ advises on strategising for PMCF compliance, highlighting areas to prioritise to ensure an efficient process.
whitepaper
eGuide: How to quickly identify contaminants in pharma
In this eGuide you will learn about an innovative 2-in-1 method for materials analysis and how your analysis for contamination identification and root cause analysis will benefit.
article
Formulation, Development & Delivery In-Depth Focus 2021
Discover how to plan for post‑market clinical follow-up compliance under the new EU Medical Device Regulation (MDR), and formulate live biotherapeutic products to enhance their effects in this in-depth focus.
video
On-demand webinar: Spores in my cleanroom
This webinar considers the problems bacterial and fungal spores present for contamination control and remediation and disinfection strategies.
whitepaper
Whitepaper: Best practices in environmental monitoring
This whitepaper outlines the important components of an environmental monitoring programme, providing practical advice and best practice guidance.
video
Video: tec5USA Anti-Counterfeit Solutions by Spectral Engines
All-in-one Drug Anti-Counterfeit Solution for improved pharma product security and brand protection, brought to big pharma companies via tec5USA.
news
Pill may replace injections for monoclonal antibody treatments
An innovative new pill can deliver large quantities of monoclonal antibodies and other drugs into the stomach lining after swallowing.
whitepaper
Application note: USP <643> TOC limit changes
This application note addresses the TOC limit changes in USP for packaged water. The new limits account for varying container volumes.
