Become a Life Sciences Quality Assurance Consultant: What are the skills required?

Posted by Adam Holmes on May 24, 2016 1:30:00 PM

In Deloitte’s 2016 Global Life Sciences Sector Outlook, the research points to “an ever-evolving regulatory and risk environment” coupled with the “growing prevalence of chronic diseases” as just two of the factors driving the growth of the biotech sector and the heightened need for skilled Life Sciences professionals.

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FDA Form 483 and Warning Letters: What's the difference?

Posted by Stephen Fochios on May 17, 2016 10:30:00 AM

When the FDA comes in to inspect a pharmaceutical or biotechnology company’s manufacturing facilities they can either alert the company ahead of time or show up unannounced. After the inspection is over the FDA can send what is called an FDA form 483 or a warning letter. There are differences and various consequences depending on how these are both handled.

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From Full-Time Employment to Life Sciences Consulting: Making the Shift

Posted by Bob Gilchrist on May 5, 2016 10:00:00 AM

Here at EG Life Sciences, we work with market leaders in the biotech, pharmaceutical and medical device industries to ensure they have the right resources to meet the unique challenges of FDA regulations. And as these organizations change and grow, the trend towards hiring consultants to quickly ramp up their efforts is clearly key to ensuring that products and therapies meet and exceed customer requirements. Now more than ever before, we are seeing great demand for consultants in the Life Sciences industry.

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Data Falsification in Life Sciences: Absolutely Not!

Posted by Stephen Fochios on Feb 24, 2016 11:00:00 AM

The Life Sciences industry is one of the most rewarding and exciting industries to be involved in.  It gives people a great sense of accomplishment when their contributions assist those who must manage or overcome a debilitating disease.  It takes years of research, development and testing – and billions of dollars - to bring just one drug to market.  In addition, the amount of information that is compiled and tracked is enormous and great care and accuracy must be taken to ensure its accuracy.  That is why it is always frustrating and concerning to hear about drug firms that intentionally falsify data and records to manipulate results into looking great when in reality they tell a different story.

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7 Common Phone Interview Mistakes & How to Fix Them

Posted by Melody Lam on Jan 25, 2016 1:30:00 PM

As a recruiter I have the opportunity to hear interview feedback from both the candidate and the interviewer. There are many times when a candidate may think an interview went well, but after hearing from the interviewer they feel the exact opposite. You can be a near perfect skill fit for a given job, but ruin your chances of being selected if you fail to impress during a phone interview. Here are some key mistakes you could be making, and how to improve the next time around:

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Single-Use Technologies in the Biotech Manufacturing Process

Posted by Stephen Fochios on Jan 5, 2016 1:30:00 PM

When biotechnology drugs are produced they require very specialized equipment during the manufacturing process. Traditionally this would include equipment such as stainless steel bioreactors and stationary protein purification chromatography columns. A growing number of well-known biotech firms are adopting what is referred to as single-use disposable technology. This technology allows its user to dispose of it after a certain step in the manufacturing process is complete.

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Medical Device Hacking: The Real Risks

Posted by Stephen Perez on Dec 9, 2015 3:00:00 PM

These days, we are bombarded by news of cyber security threats. From identity theft to credit card security breaches, these threats are very real and many of us have been victims, often necessitating the arduous task of fixing bad credit reports, investing in identity theft solutions and other similar fixes. But nowhere is the threat more critical or real than those associated with medical devices.

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Streamlining Data in Pharma & Biotech

Posted by Stephen Fochios on Dec 3, 2015 9:00:00 AM

In the ever evolving world of Biotech and Pharma there is a myriad of information that needs to be compiled and shared between different functional groups in an organization.  This includes regulatory, manufacturing, and compliance information.  Usually this information is stored in separate and often disparate electronic systems, and this data is often requested by regulatory agencies such as the FDA when they conduct inspections to approve new drugs.  What if this information was available using a single system?

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Regulation of Mobile Medical Apps

Posted by Stephen Perez on Nov 10, 2015 9:30:00 AM

As the market for mobile medical applications has exponentially expanded over the last couple of years, developers of these technologies have continued to push the boundaries of functionality, innovation and usefulness. And as consumers continue to rely more and more on the data gathered by these devices to make informed healthcare decisions, the FDA has revised their original guidance on how these devices will be regulated.

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Always Be Networking – 4 Easy Tips to Advance Your Career

Posted by Melody Lam on Nov 5, 2015 2:00:00 PM

Many people make the mistake of waiting until they’re out of a job to start utilizing their network. In reality, the most successful professionals are always networking whether it be with friends, former colleagues, targeted companies or recruiters. Even if you’re happily employed right now, proactively connecting with the right person could lend you the hand you need when the time comes to look for a new job.

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