Tag Archives: goals

  • 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 …

  • Waste Removal

    Waste Removal Lean Biomanufacturing, Dr. Nigel J. Smart The million dollar question in lean biomanufacturing is (drum roll please)….how can we go about removing all of that waste? Although the process seems rather grueling, trust in the fact that waste removal is beneficial to your research. Waste removal will have a major impact on your team’s overall biomanufacturing goals. Yes, sometimes various components of your research cannot be eliminated. And if that is found to be true within your …

  • 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

    … goals and understanding if they have been met, as well as stating the Kaizen implementation results and standardization plans. These events are no easy feat, so when they are complete, be sure to celebrate and congratulate your fellow research team, while also running with the momentum of your success to help with your next round of developments. Good luck and happy researching! For more information on Kaizen events and lean biomanufacturing as a whole, refer to Dr. Nigel J. Smart’s …

  • Change Management; A Vital Part of the Lean Mechanism within the Life Sciences Industry.

    … and before any deployment plans are finalized. Often this is best performed by an outside group such as a pharmaceutical consulting company, because this allows for a more objective assessment to be developed. One key point to address is to define for the workforce what the new “Desired State” for the company looks like. It’s very important that the management and workforce clearly understands what they are working towards and how they know when they have arrived at that point. goals and …

  • Lean Manufacturing and PAT – The Next Level For Pharma

    … analysis, process control, and continuous improvement. With these tools, pharmaceutical manufacturers can move toward the common goals of reduced cycle times, fewer rejects, increased automation, and continuous improvement in the process that are shared by PAT and lean manufacturing. The pharmaceutical industry has historically taken a reactive approach to process and quality control – that is, issues were addressed as they arose and not before. Today, however, the industry is moving away …

  • Lean Manufacturing for the Competitive Edge

    … lies the rub. Developed by Toyota in the 1950s, lean manufacturing’s primary goals are reduction or elimination of waste in all segments of the production process, and continuous quality improvement.  In its simplest form, a lean manufacturing implementation is about doing more with less as efficiently and economically as possible, without compromising quality or responsive to the demands of the customer. Historically, the pharmaceutical industries successful implementation of lean …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    … together to achieve goals. Asking questions, requiring solid references, and carefully examining track records can go a long way toward ensuring the fit that ensures success. 7. Willingness to Build Relationships Consultants are not just contractors who are called in to do a job, and then disappear when the job is finished. Good consultants have to be willing to establish long-term relationships. The right pharmaceutical consultant for your company is the one willing to establish a relationship …

  • The Continuing Journey of Lean Manufacturing in the Pharmaceutical Industry

    … that Toyota’s production, in fact, became less lean. Toyota, whose inventory turns fell dramatically from the 1990s to 2008, became too focused on growth, and lost sight of their goals of quality and continuous improvement. Management, it seems, forgot that lean manufacturing implementation is a continuing journey and that culture is key. There is a lesson for the pharmaceutical industry here as well. The pharmaceutical industry – as well as its pursuit and implementation of lean …

  • Avoiding the Pitfalls of Pharmaceutical Consulting

    … Before hiring a pharmaceutical consultant, you absolutely must do the necessary preliminary work. Neglect these important steps, and you could be courting disaster: Identify and define your needs. The first step prior to calling in a pharmaceutical consulting firm is to carefully analyze and define your goals for your company. What, exactly, do you want to accomplish? What specific problems do you need solutions for? Knowing where you are now and where you need to be will be immensely helpful …

  • How to Perform a Mock Audit

    … that will participate in a specific study. First, choose a location and a study, and later develop a plan for your mock audit based on your SOPs and on the right FDA compliance program manual. This plan should clearly state: -The audit’s goals -The project and location you chose -The participants -The time frames for completing the audit Be very diligent when addressing the requests for information that the mock inspector will issue, taking into account the significant questions about …