Preparing to Comply with the EU MDR

WHAT IS IT?

The European Union put a new MDR, or Medical Devices Regulation, into effect on May 25, 2017. The MDR replaces both the former Medical Devices Directive and the Active Implantable Medical Devices Directive. The new regulation has a transition period of three years, during which time manufacturers are expected to revise their internal production processes and related technical documentation to align with the new requirements put into effect by the MDR.1,2 Ideally, the replacement of the MDD with the MDR will encourage a greater universal compliance to stricter standards throughout Europe of regulations related to medical devices.

Read More »

Focus on Compliance: Scale Your Drug Manufacturing Capacity to Support the Product Lifecycle

Posted by Mandy Gervasio

Biopharma advancement is at an all-time high with breakthrough drugs and life-sustaining therapeutic treatments being developed, manufactured, and approved every day. It’s a space of incredible growth but also one that’s heavily regulated by the FDA and other global regulatory agencies.  Lately, there have been so many new products showing great promise and thus scaled up from Clinical Phase 1 through Late Phase Clinical II/III up to commercial launch. Clearly, there is a vast amount of work and resources required to support this growth curve. This post introduces key topics that impact the overall product lifecycle; during the coming weeks, we will subsequently break them down into tangible, action-oriented recommendations for success!

Read More »

Beyond "Just Fix It!" Application of Root Cause Analysis Methodology in SAS Programming

Posted by Nagadip Rao

In today’s world, clinical trials are expensive, complex, multi-disciplinary processes involving multiple partner entities working together to satisfy stringent regulations to improve patient lives by bringing innovative therapy to the market. Due to the competitive nature of our industry, there is a push towards increasing efficiency in order to deliver an on-time, on-budget accurate representation of clinical trial data to regulatory authorities.

Read More »

A Total Error Approach for the Validation of Quantitative Analytical Methods

Posted by Anagha Kakade

The total error approach is a statistical technique for assessing performance of analytical methods. It could be used for any lab data analysis in oncology or other clinical trials or for the testing of new drugs. Due to variable parameters involved in inter-laboratory transfer of clinical trials like analysts, instruments, day/sessions and geographic location, there are chances of different assignable and non-assignable causes of variations. Here, the statistical analysis of measurement processes helps to identify and quantify sources of variation. The total error approach evaluates the variability in the parameters and helps the scientist in decision making.

Read More »

Attend "Core Components for Contamination Prevention & Control in Biopharma Manufacturing Operations"

Posted by Stephen Fochios

On April 4th, 2017, EG Life Sciences will host a breakfast event at MassBio that will feature Gary C. du Moulin, Ph.D., M.P.H., RAC who will present "Core Components for Contamination Prevention and Control in Biopharmaceutical Manufacturing Operations." Gary recently retired as Senior Director of Quality Aseptic Control for Genzyme (a Sanofi company) where he participated in the development and execution of robust quality systems for Genzyme's products including biologics and cell based therapies.

Read More »

Data Visualization: The Epilepsy Story

Posted by Surabhi Dutta

How do we extract the right data to tell the most important stories and then present them to others in a way that can make a difference for clinicians and patients? This question is truly at the heart of data visualization. In this paper, Data Visualization: The Epilepsy Story, we aim to do just that; we tell the story of epilepsy based upon the exploratory analysis and visualization of data for clarity.

Read More »

Who's leading in biotech in 2017? East Coast vs. West Coast

Posted by Stephen Fochios

California and Massachusetts are always mentioned together when speaking about the leading life sciences clusters in the US. They frequently share the number one and number two spots on the many lists that are published in the scientific community. The reason? The abundance of world class educational institutions in these areas give companies easy access to top level talent.

Read More »

The Process Validation Life Cycle

Posted by Alan Greathouse

As times change so do the expectations of the regulators. This holds true with validation as well. More global health authorities and regulators are communicating their expectations for risk and science based justification for process control and validation approaches. Let’s take a quick look at how the definition of Process Validation has evolved:

Read More »

How to Handle Out of Specification (OOS) Results

Posted by Stephen Fochios

Your cold room just went down: now what?

Read More »

Critical KPIs for a Successful FSP Outsourcing Model

Posted by Michael Cox

Pointillism is a technique of painting using tiny dots of various pure colors, which become blended in the viewer’s eye when seen at a distance.  It was developed by George Seurat with the aim of producing a greater degree of luminosity and brilliance of color.  Alone, each colored point on the canvas is just that and only that.  It is only when these colors are properly grouped together does the picture make sense.

Read More »

Subscribe to our Blog

Popular Posts

Popular Posts