Tag Archives: smart consulting group

  • 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 other industries, yet the pharmaceutical industry continues to cling to practices that were right …

  • Fall Networking Event, a Success!

    On October 9th, SCG proudly kicked off a new networking event series with our friends from Walnut St. Labs. The event took place at Teca restaurant, right in the heart of the borough of West Chester, Pa. smart consulting group’s president, Denise Smart, hosted events of this nature several years back, so the time had come to start off this tradition once again. SCG invited local professionals in the life sciences industries, while Walnut St. Labs opened it up to many other local business …

  • 483 Audit Forms

    … need to take place. If you receive a 483 Citation and are not sure what to do next, make sure to reach out to experts in FDA consulting services…a group you can trust. The professional team at smart consulting group  has many decades of experience in remediating FDA compliance issues. Give our team a call today. We look forward to helping your company reach a positive solution!   * The above facts noted, regarding 483 citations, were referenced from the FDA’s website. For more …

  • Lean Biomanufacturing: Keeping Your Eye on the Quality Goal

    By Nigel J Smart PhD, smart consulting group To some, Lean Manufacturing is a meaningless concept when one is considering medical therapies or medical products. Often there is confusion in common English language, where the emphasis is on the Lean & Mean interpretation associated with just being efficient. As we all know this is a big misconception associated with our terminology and unless we pay attention then there is a real danger that we will miss the boat and create something that’s …

  • The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

    By Nigel J Smart PhD; smart consulting group. So you’ve decided to run a Lean Manufacturing Program at your site, and you’re thinking how best to organize and operate the program. One useful option is to enlist the assistance of an experienced Lean Consultant. Here are a few areas where a consultant can play a useful role in your program: As a sensei, the consultant can provide an objective overview of the situation and Mentor the Lean team and workforce into why it’s important to do …

  • Critical factors in Filing NDC numbers with the FDA

    There are three essential factors that need to be considered when deciding whether a new NDC number needs to be filed for a product: 1. Whether the label is different 2. Whether the formulation is different 3. Whether the packaging is different If any of these three elements changes, then this will trigger the need for new NDC numbering codes for a given product. Simply put, if the same product formulation is put into several different packaging sizes then this will trigger a new number. If …

  • Issues for Device Combination Products

    The development of medical device combination products convenience packages continues to present interesting technical and regulatory issues. Inclusion of pre-sterilized syringes and applicators as part of these products poses problems for manufacturers and distributors due to the opportunity for post sterilization residual contamination and/or plastic leachables/extractables. Most device convenience kits are ETO sterilized and this can leave ETO residuals on applicators and syringes if …

  • BARDA and their Countermeasures Initiative

    Last month was the PHEMCE conference in Washington DC which translated the governments approach to countermeasures production for the next decade or so. From the discussions it appears that BARDA will be placing a greater focus on CBRN (Chemical, Biological, Radiological & Nuclear) countermeasures issues in the future than it has in the preceding 5 years when there’s been a heavy emphasis on flu related countermeasures, H1N1, for example. In addressing these issues there would appear to …

  • Pharmaceutical Consultants-The Key to a Rapidly Changing Industry

    … performance, and enhance the quality of pharmaceutical products. Consultants can also provide solutions for the manifold certification and approval processes required by the government and other official entities for healthcare products and services. smart consulting group operates on the understanding that the client-consultant relationship is a partnership that promotes finding the best solutions to achieve the desired business objectives. With Smart Consulting, “you will have access …

  • Lean Manufacturing and PAT – The Next Level For Pharma

    In 2003 the FDA announced the Process Analytical Technology (PAT) initiative to “encourage the voluntary development and implementation of innovative pharmaceutical manufacturing and quality assurance.” This initiative was designed to improve process efficiency of both manufacturing and regulatory phases, and is comprised of four components: data analysis, process analytical tools, process monitoring, and continuous feedback. The quality-by-design aspect of PAT will reduce cycle time thus …

  • Lean Manufacturing Solves Drug Recalls and Bad Press

    … 75% of drug recalls can be attributed to manufacturing defects, the compartmentalized nature of the departments within the process, and burdensome regulatory compliance concerns among others. Further complicating the situation is the growing use of contract manufacturing organization’s (CMOs) which require companies to manage increasingly complex external relationships without compromising quality. According to Nigel Smart, Managing Partner of smart consulting group, “With so much …