Tag Archives: Pharmaceutical

  • Best Practices of Smart Consultants

    A fresh, new start…a brand new you? What kind of consultant are you and who would you like to be in 2015? As we approach the last week of the first month in 2015, if you’re like us, you may have done some self-reflecting, both professionally and personally over the last several weeks. New Year’s resolutions might be in full swing or could have possibly even been forgotten by now. A major question people ask themselves each New Year is: Who do I want to be in 2015? As a Pharmaceutical …

  • Should we be using iPhone video procedures?

    The following post was written by Dr. Nigel J. Smart, Vice President and Managing Partner at Smart Consulting Group.  With the increasing complexity of operational procedures, the use of traditional standard operating procedures must be questioned, particularly for equipment or technique operation. The use of photographic techniques, pictures and other illustrations were long advocated benefits in other industries, yet the Pharmaceutical industry continues to cling to practices that were right …

  • SCG’s thoughts on the last 10%

    For the Pharmaceutical industry, it is difficult for consumers to tell the difference between an excellent, acceptable or poor quality product.  For this reason, safety, quality and reliability problems can go undetected  until the FDA detects them during an inspection or after investigation for a product recall.  By then, the problems can be out of control and can result in a Warning Letter or Consent Decree. The below excerpt can be found here: “ // // Seth’s Blog: The …

  • WHO Ebola Vaccine Meeting

    … has 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 …

  • Bottlenecking Theory

    … computer stimulation to better scope out any potential risks. As Pharmaceutical consultants, we understand that by approaching your Pharmaceutical/scientific method in this way, you will be well equipped to combat any sort of bottlenecking issues that you may come across in your research. For more information on the bottlenecking theory please refer to Lean Biomanufacturing by Dr. Nigel J. Smart.                     …

  • Risks in Lean Compliance

    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 …

  • Kaizen Events

    … concept to take away is that each person involved in these events plays a key role in its process. In the Pharmaceutical industry one accomplishment is only the next “go ahead” to the next big idea and so on and so forth. Although time consuming, high-detail follow-up work is a must in order to best monitor and fine-tune each method. It is with this type of work that you will see adequate success with Kaizen events. Let’s first just rewind a bit and explain what is involved with a Kaizen …

  • Flow Charting

    … developing in a very systematic manner, involving products and processes that were initially defined by R&D-based bench scientists. The cost constraints involved when developing Pharmaceutical and bioPharmaceutical products are significant, which is why final methods, ideals for development and production are not established until there is some sort of understanding, or rather proof, that the material in question will be an effective medical product. Here is a list of the basic operating …

  • The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

    … apparent, so to have a Lean consultant that knows the Pharmaceutical industry will speed up your process and help to deliver tangible results using the most efficient deployment of your resources. Relative to this, the consultant will take pressure off the line management during the difficult process of culture change that is often required to produce a successful program. They do this by using their expertise and experience to demonstrate how the new approach and methodology will benefit the …

  • Venturing into the Bold World of Combination Products

    … the pre-clinical development and post-market costs associated with the Pharmaceutical aspects of the product.  Developing and supporting a combination product brings more costs than the typical medical device company is prepared to bear or has even thought about, especially a smaller device firm.  A cursory “laundry list” of considerations that come into play include the following: drug-drug interaction study, drug-polymer interaction study, drug-packaging interaction study, …

  • NDC codes: National Drug Codes and How They are Assigned

    … primary code used by the FDA. So this is a complex process that may require the filing of many systems where a product may have several packaging configurations, several formulations and several label types. Guidance through this process is best achieved by employing a Pharmaceutical consultant who can objectively steer a clear path through the maize of paperwork and forms to provide a lean process for the most effective and efficient outcome. …