Tag Archives: problems

  • Best Practices of Smart Consultants

    … set of problems. You are the team’s fact-checker. And if that’s the case, your team may feel belittled by you. Instead of constantly fact-checking your team, have a little faith in their expertise. Of course, if you know that something looks off, question it, but realize that you were all put on the team to add different levels of insight. Trust in their knowledge and perhaps you may even learn something from them… Save the drama for another industry. Don’t be the drama king or queen of …

  • 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 in a Warning Letter or Consent Decree. The below excerpt can be found here: “ // // Seth’s Blog: The …

  • Bottlenecking Theory

    … Preparation and planning is key in any industry. The best researchers understand that problems or unforeseen issues happen and accounting for those in your team’s earliest stages distinguishes the most successful teams from the not-so-successful. We can’t discuss potential problems or issues without mentioning the four letter word that overwhelmingly plays a major factor in anyone’s research…C-O-S-T. Rid yourself of any potential economic woes by creating a pilot engineering study or a …

  • Risks in Lean Compliance

    … potential risks in lean biomanufacturing, one must follow these steps in order to be successful in your research: be proactive to assess probability and potential consequences, take action to reduce the probability of unfavorable consequences, use tools to try your best to predict likely problems and make sure to take predetermined measures/actions to minimize problems, should anything arise! It’s simple, to the point, and you may be telling yourself, “Hey, I knew that all along!” It never …

  • Fishbone Analysis

    … biopharmaceutical process. For anyone who is familiar with lean biomanufacturing, one may already know that lean is most commonly identified in the biopharmaceutical industry as a “holistic and sustainable approach that uses less of everything to produce more.” The financial burdens of today’s economy most certainly play a key role in this industry, which is why researchers utilize proactive methods of experimentation to best identify problems early on in their research. A standard …

  • Issues Connected with Device Combination Product Convenience Kits

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

  • Poka-Yoke as a Mechanism to Assure Reliable Production of Pharmaceuticals and Other Life Science Products.

    … of different sizes or even different connectors might solve this issue. 2. Failure systems that did not fail closed results in loss of product or contamination of product. 3. Mix ups in products due to transfer of product dust as a result of improper air flows between adjacent pressurized rooms. 4. Double mechanical agitator seals installed incorrectly in bioreactors causing lost batches due to contamination problems. 5. Steam traps on sterilized systems connected incorrectly or not opening at …

  • 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 …

  • Pharmaceutical Consultants Broaden the Scope

    … pharmaceutical consultants provide with respect to attitudes and the way people approach problems and solutions. Why is this important? Because the way we view a problem determines in large part whether or not we find a solution for said problem, and how effective it will be. On September 11, 2001, the unthinkable happened. Foreign terrorists attacked Americans on American soil, killing and maiming thousands. The terrorists, some of whom were living in this country and had been educated here, …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    … specialized knowledge and expertise in one or more areas of the industry. While most of them can get the job done to some degree or another, the trick is figuring out whether or not (and, of course, how well) a consultant can actually fill your particular gaps and solve your specific problems. After an initial assessment, good consultants will give you an honest assessment of exactly what – if anything – they can do for you. 2. Knowledge/Experience (Team/Personnel) Again, this may …

  • Avoiding the Pitfalls of Pharmaceutical Consulting

    … Before hiring a pharmaceutical consultant, you absolutely must do the necessary preliminary work. Neglect these important steps, and you could be courting disaster: Identify and define your needs. The first step prior to calling in a pharmaceutical consulting firm is to carefully analyze and define your goals for your company. What, exactly, do you want to accomplish? What specific problems do you need solutions for? Knowing where you are now and where you need to be will be immensely helpful …