Due to the dynamic nature of technological changes and data integrity requirements companies are faced with the challenge of frequently migrating data from legacy systems.
DownloadAnalytical Quality by Design Approach to the Development Stage in the Lifecycle of an Analytical Procedure
The lifecycle approach to analytical procedures is based on processes, terms, and techniques that ensure adequate risk analysis is performed, thus reducing the chance of failure.
Lessons and learnings from implementing an efficient, cost effective and innovative Validation Lifecycle Management Systems (VLMS) program at a mid-size Pharmaceutical company
This article provides an overview of a recent academic study undertaken by the Pharmaceutical Regulatory Science Team (PRST) based at Dublin Institute of Technology (DIT), Ireland which involves the implementation of a supply chain maps management program.
Ensure consultants are motivated to decrease chances of them "burning hours" and to optimize productivity. A highlight of theories by Plato, Maslow, and contemporary case studies to help facilitate a beneficial relationship.
DownloadSpectrum of Importance – Defining Processing Parameter and Material Attribute Criticality Using Quality...
This article challenges the current binary and static approach to defining critical processing parameters and critical material attributes. It offers an alternative method to define criticality based on established methods of quality risk management which is both continuous and dynamic.
An overview of the 2012 meningitis outbreak at the New England Compounding Center (NECC) in Massachusetts, leading to a change in regulatory standards.
Gaseous sterilization is long-established but it is increasingly being reassessed and adopted due to the growth in the markets for medical devices and for single-use sterile disposable technologies for pharmaceuticals.
We are pleased to announce the winners of the annual IVT Network's Award Ceremony, which took place on day one of Validation Week, held October 17-19, 2017 in Philadelphia. IVT Network acknowledges the tremendous commttment these professionals have towards providing cutting edge and timely education to the industry. Below are the award...
The acceptance speech for Cliff Campbell, who won this years' Kenneth G. Chapman Award. With this speech, he highlights his relationship with the compliance pioneer, who in 1998 won IVT's Lifetime Achieve Award.