So what’s with all of the buzz on Ebola vaccines and how will it impact the future of this outbreak? The overwhelmingly and ever increasing amount of buzz surrounding Ebola is undeniable. Although this is not a new concept or topic of discussion in the newsroom, there seems to be no letting up as the continuous circulation of news coverage wavers on. News of a high-level World Health Organization (WHO) meeting was announced weeks ago and from that point, the speculation and discussion have only continued to develop. During the meeting, the leaders of WHO collaborated on the ways in which to establish a sensible approach to combat and stop the spread of this deadly outbreak. So what are your thoughts on the vaccine discussion? Let us know here ! The below article excerpt originally appeared here: “A high-level emergency meeting, convened by WHO at the request of several governments and representatives of the pharmaceutical industry, was held on 23 October to look at the many complex policy issues that surround eventual access to experimental Ebola vaccines. Ways to ensure the fair distribution and financing of these vaccines were discussed in an atmosphere characterized by a high sense of urgency. This sense of urgency was conveyed in many ways – from plans for the different phases of clinical trials to be performed concurrently rather than consecutively, to suggested partnerships for...Read More
On October 9th, SCG proudly kicked off a new networking event series with our friends from Walnut St. Labs. The event took place at Teca restaurant, right in the heart of the borough of West Chester, Pa. Smart Pharmaceutical Consulting’s president, Denise Smart, hosted events of this nature several years back, so the time had come to start off this tradition once again. SCG invited local professionals in the life sciences industries, while Walnut St. Labs opened it up to many other local business professionals in the West Chester area. Some of the attendees included representatives from Innovation Technology Action Group, renowned local artist, Motionista, DNB First Banking, JetPay Payroll Services, S.C. Blodgett & Co., Inc., Gallagher Consulting, IComm, SparkNET Technologies, and Fox Rothschild LLP…just to name a few. One of our lucky attendees even walked away with a gift card to Éclat Chocolate, gourmet chocolate by Christopher Curtin. We had a fantastic turn out of roughly 25-30 attendees! It was an amazing way to connect with business professionals from a wide array of industries, opening up the SCG network beyond the life sciences industry. We’re excited to announce that this is just the start of happy hour/networking events of this type for SCG. We are already in the works of planning our next networking event in the borough, so stay tuned! We appreciate all of the support we...Read More
So what’s with this 483 audit form and where do I go from here? Faced with a 483 audit form? If this is the first time your company has received a document of this nature your initial thoughts may be… now what? In order to understand the true implications of a 483 citation, it may help to think of it in terms of a speeding ticket. It’s a road block or a cause for reevaluation of your current state. Although not necessarily a serious offense, it’s an important warning to your company that should not go unnoticed. A 483 audit is issued after the conclusion of an FDA inspection. This form states that certain conditions were cited as “in violation” of FDA standards/regulations. The FDA investigator feels that the practices or conditions surrounding the product at hand is in question and therefore a change needs to be set forth, in order for operation to continue. A company must understand the problem at stake as well as the violations that are in play as a way to avoid an escalation, like a Warning Letter, which is much more severe in nature. Yet, fear not. You will not be left in the dark after receiving this 483 audit form. The FDA will also provide a detailed written report, spelling out the specific reasons for the audit known as an Establishment Inspection...Read More
Bottlenecking Theory Lean Biomanufacturing, by Dr. Nigel J. Smart Understanding this theory can help address key concepts that can help your research team yield optimal results. It’s important to begin your research by first running through some equations that will help your team throughout your experimental endeavors. After all, you wouldn’t read a book if you didn’t know its terminology first, right? It’s important to be well versed in the material that you are working on in order to make the most out of your research. You are experts in your industry so make sure to own this knowledge, for that will be the best way to reach your team’s goals. The quantity that a manufacturing site can produce in unit time is defined as: Plant throughout: Batch size X Number of batches Plant throughout: Batch Size/Cycle Time Clearly bottlenecking is not an ideal situation for your facility, so avoiding this or creating a logistical approach to offset this phenomenon is key in lean biomanufacturing. Bottlenecking can occur as a result of resource limitation as well as when one does not have the correct tools/equipment readily available. Why would a store clerk sell a shirt that is no longer in stock? They wouldn’t! This is why it’s important to know what resources or quantity you have available at all times. In the case that bottlenecking does occur, one must...Read More
What is Risk? Lean Biomanufacturing, Dr. Nigel J. Smart As the famous T. S. Eliot once said, “Only those who will risk going too far can possibly find out how far one can go.” This is most certainly the case in the science and pharmaceutical industry. We are in an industry that requires researchers to take the knowledge that they skillfully have acquired and run with it. This knowledge will not be of any use bottled up in one’s brain, unheard by others. Knowledge and the ability to take risks is what truly gets people talking and from there brilliant ideas are drawn up. Now, in the biopharmaceutical industry going lean is all about taking risks and understanding that risk. So what about the 80:20 rule you may ask? What’s all of the fuss about in regards to identifying risk in lean compliance? Let’s try and wrap our brains around this concept a bit. “Risk is a balance of certainty and uncertainty, in addition to the probability of something occurring.” It’s vital to identify potential risks before embarking on any sort of endeavor, especially something that involves time and money for your research team. By ranking and understanding the probability of various occurrences, based on a specific action or step in your process, you will have an overall better grasp on what could potentially cause issues down the line. If...Read More
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