Tag Archives: things

  • The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

    … things in a certain way. The whys, the where’s and the how’s of the situation are examples of where a Lean consultant to can play a significant role in your program. As an experienced extension of your team the consultant can quickly run a diagnostic assessment of key processes, gaps and weaknesses associated with your Current State and can get you tracking quickly. Deciding what tools to use and how to use them and provide the largest bang for your buck is also not always immediately …

  • Lean Manufacturing and PAT – The Next Level For Pharma

    … The highly compartmentalized nature of the industry fosters a manufacturing process composed of many individual parts rather than one continuous, integrated flow. Improving a process that isn’t quite a process yet can be very challenging. Additionally, there’s a reluctance to make the necessary changes – batch size,for instance – when those changes result in the added burden of extensive documentation and testing. As with PAT, the very things that need improvement are …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    … microbial/fermentation technology, as well as biochemical engineering, and Denise with training and experience in the legal arena. 3. Flexibility (Vision/Perspective) One of the worst things that can happen when you engage the services of a pharmaceutical consulting firm is that the consultants come in with a preconceived and mostly solidified idea of what needs to be done. This outlook and attitude leads to proposed solutions that probably are not going to be optimum for your specific …

  • The Smart Road to Pharmaceutical Consulting

    … industry experience. Smart Consulting offers a broad range of services in several areas—vaccines, lean manufacturing, quality and compliance, drug/device combination products, FDA regulations, and FTC concerns—with special expertise and interest in quality compliance, quality audits, laboratory strategies, and manufacturing solutions. While many of these same consulting services can be found in many other consulting firms, two things set Smart Consulting apart from the others: 1) their …

  • Transforming the Traditional Approach with Lean Manufacturing Techniques

    … along with eliminating waste, improving efficiency, creating customer value, and striving for continuous improvement, also aims to change culture. One of the main things lean manufacturing techniques can accomplish is the elimination, or at least reduction, of waste. For pharmaceutical manufacturer’s, waste most often comes in the form of excess inventory and waiting – both of which are primarily due to long lead times resulting from the historical batch orientation, as well as …

  • The Future of Regenerative Medicine

    … bioengineers picture a material system in which the embedded cells emit a signal so that deeper cells form bone white cells close to the surface form cartilage. Regenerative medicine anticipates several things: -A rising impact of cell-based therapies in clinical medicine -Methods that make it easy to regenerate skin, bone, cartilage, bladder, and trachea from bone marrow stem cells, and also the regeneration of blood vessels and heart valves -The restoration of function in complex tissues like …

  • The Benefits of Using Pharmaceutical Consultants

    Today in the pharmaceutical industry things are tough, and getting tougher – especially for smaller companies. Companies are faced with the daunting task of buckling down and finding ways to operate much more efficiently. Every penny has to be squeezed out of each dollar invested in R&D, production, distribution, marketing, and sales. This is where pharmaceutical consultants can help. Up until a few years ago, the pharmaceutical industry enjoyed healthy profit margins. Now, however, …

  • The Drive Behind Lean Manufacturing Implementation

    For many years not a lot of thought was given to production and the supply chain within the pharmaceutical industry. As long as market demand was met with quality, compliant products, production was generally ignored as an area that could lend itself to gaining a competitive advantage, and things rocked along pretty much as they always had. Today the growing cost, along with compliance and competitive pressures, are changing that attitude and executives are increasingly looking to apply lean …

  • How a Pharmaceutical Consultant Can Improve Business Health

    No doubt, things are tough—and getting tougher—for the pharmaceutical industry today, especially for the smaller companies. They now have to buckle down and find ways to operate far more efficiently than in easier times. Every drop of value has to be squeezed out of every dollar invested in R&D, production, distribution, marketing, and sales. And this is where pharmaceutical consultants can help.

  • The Future of Regenerative Medicine

    … In the end, bioengineers picture a material system in which the embedded cells emit a signal so that deeper cells form bone white cells close to the surface form cartilage. Regenerative medicine anticipates several things: -A rising impact of cell-based therapies in clinical medicine -Methods that make it easy to regenerate skin, bone, cartilage, bladder, and trachea from bone marrow stem cells, and also the regeneration of blood vessels and heart valves -The restoration of function in complex …

  • FDA Inspection Wizard: What’s Scary Can Turn Out to Be a Piece of Cake

    … for and stored. These things are normally checked: -Communication capability with the IRB, including the initial submission document, adverse event reporting, and progress reports -Totality of accountability documentation for the receipt, storage, administration, and return of test article (drug, device, etc.) -Compliance with the study protocol and documentation that each deviation/amendment received the approval of the IRB and the sponsor -Aptness of the informed consent process -Timely and …

  • What You Need to Know About Vendor Audits

    … making lists of good or bad things.  It should be looked at more as an overall assessment of finding, from which you can draw your own conclusion.  A vendor audit should be conducted to help your organization make quality decisions about services, products, vendors, and quality practices.  It will provide your company a means to verify that third party vendors meet the applicable FDA laws and regulations, while reducing liability and effort on your part. When done correctly a vendor audit can …