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.
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.
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.
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:
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.
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.
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?
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.
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.
When the FDA approves a new drug or device they usually have separate divisions that handle this. What happens when a medical device is manufactured with a drug that is also part of that device? What regulations must it adhere to? This is called a combination product and the FDA has certain guidelines on how products like these must be developed. Products that come to mind are drug eluting stents for the treatment of coronary heart disease. These products serve two functions. The primary function is to widen the blood vessels that supply the heart to reduce narrowing. The second function is for this stent to then deliver medication to the vessels to also aid in heart disease prevention.