Tag Archives: order

  • 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

    … obvious form of waste is much less than with the most technical waste removal processes that often come after. At the same token, it’s important to understand which components will take too much effort and time, as those are probably not worth your time due to little return of investment or other unavoidable factors. A decision tree process is helpful in deciding what can or cannot be eliminated, but still, a certain level of skill and experience will be necessary in order for this technique …

  • Value Stream Mapping

    … over their heads with all of the new methodologies and research findings that enter into the market. Utilizing research methods that yield the best results for your company is a major key to success in this industry. Meet value stream mapping. Isn’t it nice to think of anything in life in its Ideal State? In lean biomanufacturing it’s vital to identify the Ideal State of your process in order to truly hone in on your overall envisioning for your design. After all, a seamstress …

  • Kaizen Events

    … concept to take away is that each person involved in these events plays a key role in its process. In the pharmaceutical industry one accomplishment is only the next “go ahead” to the next big idea and so on and so forth. Although time consuming, high-detail follow-up work is a must in order to best monitor and fine-tune each method. It is with this type of work that you will see adequate success with Kaizen events. Let’s first just rewind a bit and explain what is involved with a Kaizen …

  • The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

    … Lean consultant is well placed to provide objective feedback about the program to senior management and to maintain the commitment from senior management that is required in order to deliver lasting sustainable improvements to the business. This is by no means the extent of the benefits that can be delivered using a Lean consultant, but it does effectively highlight the diverse number of areas where they can have a meaningful impact. …

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

    … their systems. This is a much misunderstood concept that is often overlooked because it takes time and expense to develop and put in place. However, given that it is the law, those ignoring the issues and failing to address the need are really jeopardizing their future business and products. Companies intending to partner with large pharmaceutical companies will find that they can negotiate better terms if they have their compliance house in order. Large Pharma likes positive results and will …

  • The Use of Process Mapping, Value Stream Mapping and Score Cards in developing a Lean Culture in Life Sciences Companies.

    … possible through the participation in metrics gathering and publication of the results which identifies the direct contributions being made by the workforce to the success of the company. Perhaps a key to successful implementation of Lean in the Life Sciences Industry is to fully engage the workforce in order to demystify the purpose. Something to think about. …

  • Pharmaceutical Consultants Broaden the Scope

    It is a widely accepted fact that consultants assist companies by analyzing and assessing each individual situation and set of circumstances. Consultants then work with that company to design and implement appropriate programs, policies, and procedures based on those results. The final step is to advise, guide, and provide training in order to take the company from where they are now to where they need, and want to be. What’s far less well understood, however, is the value that …

  • The Right Sequence for Lean Manufacturing Implementation

    … downtime later on—a step that enhances effectiveness first in order to promote manufacturing quality and efficiency over the long run. A complete, successful lean manufacturing implementation requires a shift in paradigm from top to bottom—changing the emphasis to thinking about processes in terms of continuous, ongoing improvement. According to Thomas Friedli (“Operational Excellence: Pharma’s Missed Opportunities,” pharmamanufacturing.com), “This challenge is never …