Tag Archives: time

  • Best Practices of Smart Consultants

    … more to the job than being the team cheerleader. Don’t be a cruise ship director this year! If the person above sounds a lot like you, perhaps it’s time to get a bit more hands-on in your consulting work in 2015. Refine and sharpen your skills. Focus on having more of an action role on your team. Positivity is key, but without your expert insight and a hard work ethic, you’re merely just a cruise ship director whose sole focus is to ensure that everyone is having a good time. That will not …

  • Should we be using iPhone video procedures?

    … for the 1940-50’s. Other industries have long since moved on and so should the pharmaceutical industry. Use of modern video records, diaries and commands should become the new accepted practice bringing our industry into the 21st century. Scientific studies prove that these types of tools are much more effective in assuring that processes are properly operated compared to written procedures which frequently collect dust on the shelves. Perhaps the time is right to be more interactive and …

  • Fall Networking Event, a Success!

    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 Consulting Group’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 …

  • 483 Audit Forms

    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 …

  • Bottlenecking Theory

    … 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 …

  • 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 …

  • Waste Removal

    … as “low hanging fruit” components. Before going ahead and investing major time and effort into complex waste removal practices start with the materials that can most obviously be considered waste. Although this seems logical, many would be surprised at how many researchers overlook this step in lean biomanufacturing and instead strategize complex methods for removing harder to eliminate waste. Don’t fall victim to this practice. Don’t overlook the obvious. The effort to remove the most …

  • 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

    … 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, …

  • Lean Biomanufacturing: Keeping Your Eye on the Quality Goal

    … global market where cost, time to market and short cycle times play such a critical role in the success of a product. However, with that being said, the focus on product quality has at least as much an impact on success because this is so tightly bound with product safety and the eventual successful deployment of the product as a medicinal agent. The social responsibility associated with making a safe medical product is extremely important as the consequences of a defect are connected to the …

  • Leachables and Extractables in Biopharmaceutical Processing

    … With all this activity going on its often helpful to solicit the help of a consultant that is aware of the issue s to help guide a path forward. In developing protein therapeutics that may be sensitive to contact with rubber and plastic components, the potential effect of Leachables over time can become a critical processing consideration. To help to address this issue, part of the modern approach is to use Risk Assessment and Risk Mitigation strategies to first quantify the extent of the …