Tag Archives: 21st Century

  • Should we be using iPhone video procedures?

    … for the 1940-50’s. Other industries have long since moved on and so should the pharmaceutical industry. Use of modern video records, diaries and commands should become the new accepted practice bringing our industry into the 21st Century. Scientific studies prove that these types of tools are much more effective in assuring that processes are properly operated compared to written procedures which frequently collect dust on the shelves. Perhaps the time is right to be more interactive and …

  • Lean Product Change–Over in an FDA Regulated Environment

    … compliance functions, where as Lean requires similarly strict adherence to operating modalities that assure efficiency, repeatability and overall process capability. Where much of the conflict appears to reside is in relation to how that execution is achieved. However, with the advent of recent new guidance documents which include GMPs for 21st Century, ICH Q8, Q9 & Q10, we’re seeing a more pragmatic approach to compliance that is more systematic and which lends itself to fit naturally …

  • Lean Enterprising; A term coming of age in the Implementation of Lean in the Life Science Industry

    … As a result more integrated approaches now involve the inclusion if IT/IS systems and networks, production control systems, supply chain and supplier networks, compliance & regulatory systems and the use of the organization’s human resources.. Proper integration of these factors, where there is a focus on proper human resource development & their application to waste minimization, and an emphasis on customer driven production, is at the heart of the new 21st Century paradigm for the …

  • Counteracting Expanding FDA Reporting Requirements Through Lean Manufacturing

    The pharmaceutical industry faces ever higher hurdles in the 21st Century. With the recent rash of drug recalls – 2009 is the record year so far – one hurdle that is wreaking havoc with previous profit margins and just keeps growing is that of expanding regulatory compliance burdens and reporting requirements. And now the FDA appears to be raising the bar even higher with its proposed amendments to the Investigational New Drug Safety Reporting Requirements, which take effect 28 March …

  • Behind The Increasing Need for Pharmaceutical Consultants

    … still remaining competitive. One of the three main drivers in the push toward outsourcing is, of course, FDA regulations. A few of the major developments in the last few years are: August 2002: The FDA set in motion a new initiative entitled the Pharmaceutical Current Good Manufacturing Practices (cGMP) for the 21st Century: A Risk-Based Approach. This initiative focuses on the risks to public health that could result from flaws in manufacturing procedures. The stated purpose is to ensure that …

  • The Lean Laboratory of the 21st Century

    … effectiveness.  But what will the Lean approach be in the ever evolving pharmaceutical world of the 21st Century, and what innovative role will it play in directing companies towards less waste and more productivity? Lean manufacturing principles go hand in hand with the pharmaceutical industry because they both rely on the principle of manufacturing thousands of batches of product with minimal variation, at the lowest possible price.  By determining out the most cost-effective way to develop …

  • Is the Pharmaceutical Industry Going Green?

    … years that going green is more expensive, and it just wasn’t practical in these economic times.  But recent studies are starting to show that not only is going green often the cheaper option, but may help companies survive longer as the nature of business changes in the 21st Century. A key aspect to green chemistry is minimizing or eliminating the use of all unnatural or hazardous chemicals.  Many companies such as Pfizer are finding innumerable ways to cut down on harmful chemicals by …

  • How Bioscience Companies are Using Social Media to Reach Key Audiences

    … climate of the 21st Century.  Many pharmaceutical consulting experts are finding it more and more important for the pharmaceutical industry to enter into this realm of social media, and find it will be more common place in the next 5 years.  Because social media is an excellent place for drug companies to utilize online support groups, as well as discuss treatments and medications with patients online, this trend will only continue to grow.  Marketing through social media will help create not …

  • The Future Lies in Two Words – Emerging Markets

    … seems that whichever company figures out the best plan first to how to successfully tap into these emerging drug markets, will lead the global pharmaceutical marketplace well into the 21st Century. If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source). Don’t Forget to Subscribe by RSS or Email: …

  • Why the Pharmaceutical Industry Needs to Adapt to Emerging Markets

    … industry, the rest of the world is catching up fast.  With the economic downturn in the United States and Europe affecting the growth of these two previously booming economies, emerging economies like China and India are expected to be the beneficiaries in the long run.  With their two economies growing at a much faster pace than the US and Europe, there is no doubt that they will be major players in the pharmaceutical industry of the 21st Century.  Pharmaceutical consultants believe the two …

  • What is Pharmaceutical Outsourcing?

    … next level of improvement and innovation.  In order to meet the ever evolving market demands of the 21st Century large pharmaceutical companies are being forced to improve the way they operate, based on innovation and efficiency.  Outsourcing for these large companies can have many advantages, but there are many barriers in the process. One of these barriers to the global conflagration of outsourcing efficiency is that most outsourcing services are very specific to only one or two jobs.  …