Tag Archives: help

  • 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

    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

    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 …

  • Waste Removal

    … to work. A tool like a Pareto curve will also help to identify how important it is to remove various materials or components from your work. Of course with modern technology, researchers can readily identify many components of their methodologies more easily than in the past, which is another important aspect to remember in lean biomanufacturing. …

  • Value Stream Mapping

    … When it comes to optimizing the value stream map, one must analyze “the map for waste wherever the flow is less than ideal/perfect.” Asking better questions throughout your research process will help to more easily identify the non-value-added functions and extract it out to produce more immediate results. Evaluating the Current State through value stream mapping and questioning the major steps will be of most benefit to you and your team’s research. For a more in-depth look at value …

  • 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 …

  • Fishbone Analysis

    Understanding the Basics of Fishbone Analysis Lean Biomanufacturing, Dr. Nigel J. Smart Tackling the demands of the biopharmaceutical industry can prove to be quite trying in today’s competitive field. Yet with proper research and experimentation, companies can readily understand the kinks in their systematic methods early on, leading to great success in their research. Tools like fishbone analysis can ultimately help yield accurate results and benefit researchers in the long term within their …

  • 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 …

  • 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 …

  • Metrics and their Importance in Lean Biomanufacturing

    … their income stream is entirely tied to throughput from their plant and not through revenue generation from product sales, unlike innovator companies. Through careful application of process analytics, often with the help of pharmaceutical consultants, winning strategies can be developed to assure a “Right First Time” mentality is instilled in the operating culture, which enables this approach to make a meaningful impact on downtime reduction and production cycle time. …