200+ followers. WOWWWWWW…

Hello Everyone, Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community. we are so incredibly […]

Unravelling the DHF, Technical File and Design Dossier

Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU’s regulatory body, the MDD. The Design History File The […]

Design Control for Medical Devices

Design Control for medical devices is of utmost importance to the medical device industry. In order to get a grasp of its importance, one needs to get an understanding of what Design Control is. In simple terms, Design Control for medical devices is a set of logical and linear steps that medical device manufacturers have […]

What are the potential areas of risk management?

  The most critical aspect of risk management is the identification of potential areas of risk management. This helps the organization to stay focused on the areas in which it could possibly face risks, rather than taking an aimless view and shooting about in the dark. In a very broad sense, the potential areas of […]

Process Development and Validation rest on the right Design of Experiments and Statistical Process Control

The application of DOE and SPC to the development, design and monitoring of manufacturing and testing requires the use of procedures. Why? It is because in a recent guidance document on Process Validation, the FDA has named the Quality Unit as being responsible in the review and interpretation of DOE and SPC studies. The Quality […]

Medicaid platinum, silver for the rest

Insurance Commissioner Roger Sevigny … Findings of report are “not conclusive.” CONCORD — The path New Hampshire has taken toward expanding Medicaid is pushing prices up for everyone else who buys health insurance on the Obamacare exchange at healthcare.gov, according to an analysis recently completed for the Insurance Department. The average medical costs for the […]

Quality by Design using Design of Experiments 2017

The ICH has offered further guidance and policies for explaining the ways by which the QbD approach should be integrated into the pharmaceutical Quality System

Design of Experiments (DoE) for Process Development and Validation

DoE is important for process development and validation as it offers an understanding of the predictability

Seminar Calendar of Upcoming Courses – June to July – 2017

seminars are a wonderful opportunity for professionals in the regulatory compliance