Tag Archives: *Check

  • 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 resolutions might be in full swing or could have possibly even been forgotten by now. A major question people ask themselves each New Year is: Who do I want to be in 2015? As a pharmaceutical …

  • WHO Ebola Vaccine Meeting

    So what’s with all of the buzz on Ebola vaccines and how will it impact the future of this outbreak? The overwhelmingly and ever increasingly amount of buzz surrounding Ebola is undeniable. Although this is not a new concept or topic of discussion in the news room, there seems to be no letting up as the continuous circulation of news coverage wavers on.   News of a high-level World Health Organization (WHO) meeting was announced weeks ago and from that point the speculation and discussion …

  • 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 team’s overall biomanufacturing goals. Yes, sometimes various components of your research cannot be eliminated. And if that is found to be true within your …

  • Avoiding the Pitfalls of Pharmaceutical Consulting

      In an effort to remain competitive in an industry impeded by increasing R&D, production, and marketing costs, as well as growing generic competition, regulatory compliance burdens, and government intervention, more and more pharmaceutical companies are looking outward for assistance. The right pharmaceutical consultant can be a valuable asset, providing a competitive edge and a healthy return on investment, but there are pitfalls that must be avoided. 1. Not Doing the Preliminary Work …

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

    Although FDA inspections of clinical sites are not an indictment of something being wrong with a clinical site, it can nevertheless still be a scary experience, especially if you are not properly prepared. An FDA inspection is basically a quality assurance process that is used to confirm clinical data management/integrity and regulatory compliance.  Here we show you how to make it a piece of cake for your site and your nerves. Kinds of inspections -The most common FDA inspection is the …

  • Guilty as Charged: The Premature Stop of Clinical Trials Exaggerates the Effects of Treatment

    A study of almost 100 clinical trials that were stopped prematurely because they showed positive treatment effects has shown that a large number of those effects were exaggerated. The study was published in the Journal of the American Medical Association and recommends that researchers do not fall for the temptation to end clinical trials prematurely but rather continue with them for longer periods of time before thinking about ending them. Victor Montori, M.D., Mayo Clinic endocrinologist and …

  • Failing an FDA Inspection

    Although your company may prepare itself sufficiently, even going over and above the necessary steps in preparing for your FDA audit inspection, there is still a chance that your company may not pass the test.  So what then?  So what happens if all your pre-inspection preparation is all for nothing, and you failed your inspection anyway?  Well it doesn’t exactly mean that you’ll get thrown in jail, or have your company wiped off the books anytime soon, but it may cause serious …

  • Be Prepared When the FDA Knocks on Your Door

    This is the drug manufacturer’s nightmare: the phone rings and an FDA official announces an upcoming inspection.  Even though they are clearly necessary, FDA inspections are a weight on pharmaceutical companies’ shoulders.  Without these inspections, pharma companies cannot keep the FDA’s approval to sell their products. It is the FDA’s duty to call in advance to announce an inspection, its purpose, duration, and number of people involved.  On inspection day, the FDA official will ask …

  • How to Prepare for the New Structure for Approval of Follow-on Biologics

    Under the Hatch-Waxman Act, every generic candidate has to give the holder of the approved New Drug Application (NDA) notice of the filing of the ANDA.  As soon as they receive it, in turn it files a patent infringement lawsuit that starts a thirty-month stay, making it impossible for the FDA to approve the ANDA without a final court judgment favoring the generic candidate. With the proposed HR 1427 and HR 1548, the generic candidate has to notify the Biologic License Application (BLA) holder …

  • Ensuring QC for Laboratory Operations

    In order to assure that a company has a well functioning organizational structure executive management needs to be very proactive. No where is this more the case than in the QC laboratory environment. Audits and warning letters are very common within the pharmaceutical industry, and issues connected with both of these are very common in dealing with  laboratory operations. Given the complexity of QC operations, situations where this is under control is impressive given the criticality relative …

  • Tips For Effective Process Mapping

    Process mapping can be an excellent way for your pharmaceutical company to improve and monitor specific processes to ensure that your operations are running smoothly and efficiently.  Because the day to day work of businesses, specifically pharmaceutical companies, usually involve a multitude of different processes, mapping them out in specific charts and graphs can help to make the work look more visible and increase understanding among employees.  It also helps employees who are working on …