Tag Archives: knowledge

  • Best Practices of Smart Consultants

    … go over well and we’re certain that your consulting career may take a turn for the worse if your work attitude does not change. There are so many different personalities out there. Perhaps you are the professor…Are you the person on the team who enjoys giving a brief lecture to nearly anyone and everyone around you? News flash: You’re working with many highly skilled, senior-level consultants… you can spare them the lecture. Yes, it’s great to show your interest and knowledge of the …

  • 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

    What is Risk? Lean Biomanufacturing, Dr. Nigel J. Smart As the famous T. S. Eliot once said, “Only those who will risk going too far can possibly find out how far one can go.” This is most certainly the case in the science and pharmaceutical industry. We are in an industry that requires researchers to take the knowledge that they skillfully have acquired and run with it. This knowledge will not be of any use bottled up in one’s brain, unheard by others. knowledge and the ability to take …

  • Metrics and their Importance in Lean Biomanufacturing

    There is no doubt that metrics are an important component of any well run pharmaceutical process. Without knowledge derived from the data that details the critical process parameters, it is like running blind into a storm without a compass or GPS with which to navigate. Modern biopharmaceutical processes are extremely complex and require synchronization of many process parameters. Without this attention to detail, it is impossible to generate the type of operating capability that produces a …

  • Pharmaceutical Consultants-The Key to a Rapidly Changing Industry

    When market conditions, and methods of manufacturing, testing, and technology remain virtually unchanged for long periods, companies within that industry generally manage quite well doing everything in-house. However, when an industry finds itself in the throes of rapid and unexpected change, outside experts are often needed to provide the knowledge and expertise necessary for corporate survival. That is exactly where the pharmaceutical industry is, and why the value of pharmaceutical …

  • Lean Manufacturing and PAT – The Next Level For Pharma

    … industry has resulted in a narrow focus on avoiding mistakes, rather than improving processes. Because of this, error-free documentation (largely paper-based) becomes more important than advanced knowledge of the process – a philosophy that is in direct conflict with the risk-based approach and process understanding set forth by PAT. Another factor is that some companies simply aren’t ready for advanced control from a technological standpoint. Chart recorders – where operators …

  • 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 …

  • 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 …

  • The Continuing Journey of Lean Manufacturing in the Pharmaceutical Industry

    … picking and choosing the parts that suited them. This approach has led to minimal improvement, at best. Additionally, most of the pharmaceutical industry is compartmentalized, with each segment clinging to its own range of territory and operations to the exclusion of others. A holistic approach that would meld all areas into one functioning entity, as well as encompasse the entire process and product flow is needed. Managing knowledge – Manufacturing must be viewed as an integral …

  • Making Relationships Count With Life Sciences Consulting

    … sponsor are changing, and they will continue to evolve as time passes. While life sciences consulting firms can be a huge asset for companies seeking to maximize the value of their use of CMOs, managers have to realize that because of the evolving nature of CMO use, the consultants they call in must be willing to establish long-term relationships. If the consulting relationship is to work, prospective consultants should demonstrate the willingness, have the personnel, and possess the knowledge …

  • Avoiding the Pitfalls of Pharmaceutical Consulting

    … in finding the right consultant to move your organization from the starting point to the desired goal. Make sure the knowledge and experience are there. Another important step is to make sure the prospective consultant has the necessary expertise – in the form of knowledge, experience, and qualified personnel – to do what you need them to do. Read their publications, check references, and scrutinize track records. Ask lots of questions. Ask yourself and the prospective …

  • Qualified Lean Manufacturing Consultants: Make or Break

    … companies have been reluctant to adopt and implement lean manufacturing techniques due to skepticism that production solutions coming from the auto industry can’t really be successfully applied to the special conditions of the pharmaceutical industry. This fear is both justified and unjustified – the difference usually boils down to the use of qualified lean manufacturing consultants with industry-specific knowledge and experience. Here’s an apt illustration from another sector …