Tag Archives: team

  • Best Practices of Smart Consultants

    … consulting company, we encounter a vast array of personalities within our client/business relations. From there we began to ponder: What kind of consultants do we consider near and dear to our heart? Is it the cruise ship director? The person who is likely to sit back and watch their team assign roles and work for each other while they help to boost the overall team’s morale? Although keeping it positive is an amazing and sometimes hard to find trait among people in this industry, there is …

  • 483 Audit Forms

    … need to take place. If you receive a 483 Citation and are not sure what to do next, make sure to reach out to experts in FDA consulting services…a group you can trust. The professional team at Smart Consulting Group  has many decades of experience in remediating FDA compliance issues. Give our team a call today. We look forward to helping your company reach a positive solution!   * The above facts noted, regarding 483 citations, were referenced from the FDA’s website. For more …

  • Bottlenecking Theory

    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 …

  • 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 …

  • Value Stream Mapping

    Value Stream Mapping Lean Biomanufacturing, by Dr. Nigel J. Smart No one company can do it all. It’s nearly impossible to implement every fresh, new research method that enters the market into your company’s regimen. To put it simply, not every method may best fit your company’s overall goals. Understanding this key concept will be invaluable to your research team’s overall operations. Science is ever-changing and although the industry is bursting with excitement, one can get a bit in …

  • Kaizen Events

    Implementing Kaizen Events into Your Research team’s Methodology Lean Biomanufacturing, Dr. Nigel J. Smart In lean biomanufacturing the term Kaizen events “refers to the impact of the outcome relative to the cost expended.” Much different than most constructive concepts, in a Kaizen event once the main event is complete, the researchers’ work is far from over.  In fact, their work has only just begun. These processes are quite complex and require strong attention to detail. A vital …

  • 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, …

  • The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

    By Nigel J Smart PhD; Smart Consulting Group. So you’ve decided to run a Lean Manufacturing Program at your site, and you’re thinking how best to organize and operate the program. One useful option is to enlist the assistance of an experienced Lean Consultant. Here are a few areas where a consultant can play a useful role in your program: As a sensei, the consultant can provide an objective overview of the situation and Mentor the Lean team and workforce into why it’s important to do …

  • Don’t keep failing, implement a LEAN Laboratory approach!

    … First, have an experienced Lean laboratory consultant on your team. Second, work with them to develop a plan that will transform how you’re running the laboratory operations. Third, make a commitment to integrate the QC laboratory as part of an overall operational strategy so that the laboratory is not an isolated function that’s exposed to changes in production priorities. So what are some of the important factors that we need to consider in transforming the current situation to a Lean …

  • Visual Factory Methodology to improve Lean Manufacturing in Life Science Product Companies

    …  – Providing the most appropriate mechanism to assure that this conveyance occurs effectively. To accomplish this objective then, it is very important that the factory operating team has a clear understanding of the “current state” situation at the plant as well as what level of performance they want to transition too. By knowing this information, the team can focus on the conveyance of that information which will bring about that change. Frequently this will be through the …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    … specialized knowledge and expertise in one or more areas of the industry. While most of them can get the job done to some degree or another, the trick is figuring out whether or not (and, of course, how well) a consultant can actually fill your particular gaps and solve your specific problems. After an initial assessment, good consultants will give you an honest assessment of exactly what – if anything – they can do for you. 2. Knowledge/Experience (team/Personnel) Again, this may …