• Best Practices of Smart Consultants

    A fresh, new start…a brand new you? What kind of consultant are you and who would you like to be in 2015? As we approach the last week of the first month in 2015, if you’re like us, you may have done some self-reflecting, both professionally and personally over the last several weeks. New Year’s […]

  • Should we be using iPhone video procedures?

    The following post was written by Dr. Nigel J. Smart, Vice President and Managing Partner at Smart Consulting Group.  With the increasing complexity of operational procedures, the use of traditional standard operating procedures must be questioned, particularly for equipment or technique operation. The use of photographic techniques, pictures and other illustrations were long advocated benefits in […]

  • Consolidation Activity in the Generic Sector

    Consolidation within the generic industry continues to occur at breakneck speed through merger and acquisition activity. Multiple major players are engaged in not one but several mergers simultaneously, a fact that’s perhaps confusing to some people on their respective supply chains. Integration activities often spawn their own issues as organizations with quite different cultures are […]

  • SCG’s thoughts on the last 10%

    For the Pharmaceutical industry, it is difficult for consumers to tell the difference between an excellent, acceptable or poor quality product.  For this reason, safety, quality and reliability problems can go undetected  until the FDA detects them during an inspection or after investigation for a product recall.  By then, the problems can be out of control and can result […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]