Tag Archives: work

  • 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 …

  • SCG’s thoughts on the last 10%

    … tragedy of the last 10% In a competitive market, if you do the work to lower your price by 10%, your market share grows. If you dig in deep, analyze, re-engineer and make thoughtful changes, you can lower your price another 10%. This leads to an even bigger jump in market share.” …

  • 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. …

  • 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 …

  • 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 …

  • Do Start up Life Science Companies need Quality Management Systems?

    … expectations for the products they are developing and commercializing. So you just can’t leave it for later because you’re not going to be inspected. The regulatory agencies expect that you comply with the law even though they’re not necessarily checking up on you. Modern regulatory agencies require companies to have Management Controls and a Quality Plan in place even when their product development is at an early stage. As a result you can’t just leave it to your vendors and work off …

  • Metrics and their Importance in Lean Biomanufacturing

    … inoculum preparation and work up can be appropriately synchronized to assure that the tanks are ready to be re-inoculated with the next batch once they have been cleaned and re-sterilized. This should be a key area of focus for both fully integrated companies that have their own facilities or CMO’s that provides manufacturing services for client companies. In either case, lost production time has an impact on both business models, although for CMO’s there may be a greater pressure because …

  • Eliminating Pharmaceutical Manufacturing Chaos through Implementation of an Effective 5S Program

    From our experience most mature pharmaceutical plants contain equipment which is unused or stored within the confines of the “active manufacturing space” where the chemical/biochemical process is operating. In most cases this is at best clutter which prevents efficient use of the space on the manufacturing floor. In worst case scenarios it is actually a massive impediment because it often prevents material, product, or personnel flow during the operation of the process. work arounds are …

  • Lean Manufacturing and PAT – The Next Level For Pharma

    … preventing companies from taking the necessary steps toward that improvement. While the principles of the FDA’s PAT initiative share similar goals with lean manufacturing solutions, and are well suited to work in unison, or at least in tandem, there are also similar obstacles preventing their full implementation. However, those obstacles are far less daunting when pharmaceutical consultants and lean manufacturing consultants step in to advise and guide the way. To learn more about how lean …

  • Lean Manufacturing Solves Drug Recalls and Bad Press

    … new blockbuster drugs, and the cost of bringing new drugs to market running in the neighborhood of $1.5 billion, drug companies are struggling. The opportunity for them to benefit from a new image and from lean manufacturing implementation is at hand. Lean manufacturing techniques do work, but effective implementation in the pharmaceutical industry requires knowledge of the special circumstances that exist in the industry, i.e. the difficulties involved in altering batch sizes, the fact that …

  • Pharmaceutical Consulting and BMI’s 4th Quarter Update

    … examine each situation and problem from every perspective then, through analysis and testing, formulate multiple possible solutions. Management and consultants then work together to determine the best solution. Some of the critical areas that pharmaceutical consultants can provide assistance with are: Quality and compliance Good manufacturing practices (GMP) FDA regulatory concerns and adherence Laboratory services Lean manufacturing Training and coaching Smart Consulting Group is …