Tag Archives: potential

  • Bottlenecking Theory

    … Preparation and planning is key in any industry. The best researchers understand that problems or unforeseen issues happen and accounting for those in your team’s earliest stages distinguishes the most successful teams from the not-so-successful. We can’t discuss potential problems or issues without mentioning the four letter word that overwhelmingly plays a major factor in anyone’s research…C-O-S-T. Rid yourself of any potential economic woes by creating a pilot engineering study or a …

  • Risks in Lean Compliance

    … 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 you’ve read SCG’s blog on waste removal, some of these concepts may not be unfamiliar to you. When identifying and understanding …

  • Flow Charting

    … principles defined in developing the flow of process: Process starting point Tasks/Actions Decision points (Yes or No) Tasks/Actions after the established decision has been made Process End Point A concise way of developing and analyzing potential medical products, the flow charting method is an effective way to ensure that the active materials in question are in line with the medical guidelines set forth by the industry. It is no question that flow charting can alleviate much of the time and …

  • Fishbone Analysis

    … fishbone diagram follows a simple, yet systematic approach to understanding the potential downfalls of each of the mechanisms in a biopharmaceutical process (i.e. materials, methods, machines, measurements, environment, and people.) Using fishbone analysis, a team of researchers creates a list of reasons to identify various problems in their findings. When utilizing this technique, one of the best practices involves creating a simple chart (template) for the responses of the research time, …

  • Leachables and Extractables in Biopharmaceutical Processing

    With the burgeoning interest in the use of disposables for the production of modern biopharmaceutical products, the level of scrutiny surrounding the topic of Leachables and Extractables has moved into a higher gear. It seems that there is an endless amount of attention being paid to this topic because of the potential impact on patients receiving biopharmaceutical based therapies. As a result there is a frantic level of regulatory activity as scientists attempt to predict and quantify whether …

  • Reaching into Research and Development of a Supply Chain Strategy

    … selection of raw materials and components and their suppliers early in the development cycle. The strategy should be based on risk management principles and the needs and demands of the commercial market. The strategy would consider the unique attributes of the material and suppliers balanced against the potential risks that may be encountered when manufacturing for the commercial market. To read the full white paper, click on the following link: Reaching into Research and Development for …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    … situation. Instead, what is needed is for your consultants to look at the problem(s) from every possible angle and perspective, analyze and test ideas, and then develop multiple potential solutions. Then, together, you can decide which solution will be the best one – not only now, but also in the long run. Flexibility doesn’t end there, however. For example, the project associates with Smart Consulting can even work as substitute staff and as temporary team members if need be. 4. …

  • Making Relationships Count With Life Sciences Consulting

    … methods are often the same methods used 10 or 20 years ago. Consequently, this strategy very often falls short of achieving the maximum potential value for life sciences companies. Initially, the CMO-sponsor relationship was entered into chiefly as a tactical, specific solution. Later, owing mostly to quality issues that began to crop up, central governance was created. And more recently, in the effort to build global networks, emphasis has been on the supply chain. The dynamics between CMO and …

  • Avoiding the Pitfalls of Pharmaceutical Consulting

    … recipe for less than stellar results. The pharmaceutical consultant you choose should have the ability to view and analyze your situation from various viewpoints and perspectives, the willingness to find and test multiple potential solutions, and the experienced personnel to step up and fill in where needed. To illustrate, here’s how Smart Consulting Group handles the solution-finding process in a manner that incorporates flexibility and leads to long-term results. The consultants with Smart …

  • The Smart Road to Pharmaceutical Consulting

    … profitable is getting tougher for pharmaceutical companies – especially smaller firms, as well as health care organizations. John R. Kimberly, Management Professor at Wharton University of Pennsylvania, warns that the “old model is dead, and big pharma is struggling to come to terms with what new model is going to work.” The trick then is figuring out exactly which of the myriad of potential solutions will enable companies to remain competitive and stay in the market. Added to that is …

  • Counteracting Expanding FDA Reporting Requirements Through Lean Manufacturing

    … drug, expedite the FDA’s review of the critical safety information, . . . [and] promote a consistent approach to safety reporting internationally.” The potential problem lies in the fact that some of the language is imprecise, ambiguous, and may impose further compliance and reporting burdens on pharmaceutical manufacturers. For example, a “suspected adverse drug reaction” is defined as a “noxious and unintended response to any dose of a drug product for which …