How To Keep Compliance With Title 21 CRF Part 11 And EU GMP Annex 11
This white paper analyses the requirements of Part 11 and Annex 11 as they apply to environmental monitoring and validation, and outlines how Vaisala’s Continuous Monitoring System software viewLinc helps firms meet the requirements of both.
WHITE PAPERS & CASE STUDIES
Improve Your Facility Monitoring System To Comply With Regulatory Requirements
A facility monitoring system (FMS) is a process monitoring tool that collects data from sensors such as optical particle counters, differential pressure sensors, and temperature probes in realtime. Acronyms are independent monitoring system (IMS) or environmental monitoring system (EMS). Software presents that data as information; real-time alarms notify facility operators of alert limits to enable an immediate response to an unwanted event or excursion. Reports and trend graphs can be produced.
Clinical Trial Logistics In Africa: Ensuring Quality, Compliance And Control
Today’s Africa has increasingly become a source of fascination for pharmaceutical researchers drawn to the study and control of both communicable diseases such as malaria, tuberculosis and HIV/AIDS as well as diseases of the developed world like cancer, diabetes, hypertension and chronic respiratory disease. By World Courier
Exceeding GMP Of Medical Devices At Each Step In The Production Continuum
Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.
Don’t Get Blindsided By New USP Quality Standards
The U.S. Pharmacopeial Convention’s (USP’s) Chapter 41 minimum quality standards for weights and balances have been updated after twenty years – and every pharmaceutical manufacturer has been waiting to see what that means in practice when the standards go into effect in December 2013. By Dirk Ahlbrecht, Sartorius Group
LIFE SCIENCE WEBINARS
Understanding Your Specifications to Select the Best Measurement Instrument for Your Application
The challenge is making sure the accuracy of an instrument complies with your specification – where do you find this?
MVA applied to Raman Spectroscopy
This webinar will cover multivariate data analysis applied to Raman data.
Multivariate Statistical Process Control and Batch Monitoring
This webinar will cover the basic concepts in multivariate data analysis, with special emphasis on Process Control
Enabling Oral Delivery of Sensitive Molecules
By eliminating the need for enteric coating, ECDDT can enable the oral delivery of sensitive molecules, such as nucleotides and peptides, biological products such as vaccines, and live biotherapeutic products (LBPs), which can degrade at the high temperatures or can be sensitive to aqueous coating solution associated with coating processes.