Tag Archives: level

  • Best Practices of Smart Consultants

    … go over well and we’re certain that your consulting career may take a turn for the worse if your work attitude does not change. There are so many different personalities out there. Perhaps you are the professor…Are you the person on the team who enjoys giving a brief lecture to nearly anyone and everyone around you? News flash: You’re working with many highly skilled, senior-level consultants… you can spare them the lecture. Yes, it’s great to show your interest and knowledge of the …

  • Consolidation Activity in the Generic Sector

    … developed to assume that products will remain available to consumers at the right price. As producers drop out, monopolies are developed and the Federal Trade Commission is obliged to step in to protect competition and consumer choice.  This involves its own level of management which can also put stress on the company to deliver products to the consumer. So beneath the economic/business surface news of an acquisition/there’s the underlying practical considerations which may be overlooked …

  • 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

    … obvious form of waste is much less than with the most technical waste removal processes that often come after. At the same token, it’s important to understand which components will take too much effort and time, as those are probably not worth your time due to little return of investment or other unavoidable factors. A decision tree process is helpful in deciding what can or cannot be eliminated, but still, a certain level of skill and experience will be necessary in order for this technique …

  • Leachables and Extractables in Biopharmaceutical Processing

    With the burgeoning interest in the use of disposables for the production of modern biopharmaceutical products, the level of scrutiny surrounding the topic of Leachables and Extractables has moved into a higher gear. It seems that there is an endless amount of attention being paid to this topic because of the potential impact on patients receiving biopharmaceutical based therapies. As a result there is a frantic level of regulatory activity as scientists attempt to predict and quantify whether …

  • Don’t keep failing, implement a LEAN Laboratory approach!

    … laboratory? Below is a short list of some of the more important features that you will need to build into the transformation plan. • A process to provide a consistent leveled supply of samples • A process that significantly reduces the lead times involved • A process that reduces the level of work in progress • A process that reduces the overall cycle-time for analysis • A process that streamlines data processing If these issues sound familiar to your situation and you want to …

  • Visual Factory Methodology to improve Lean Manufacturing in Life Science Product Companies

    …  – Providing the most appropriate mechanism to assure that this conveyance occurs effectively. To accomplish this objective then, it is very important that the factory operating team has a clear understanding of the “current state” situation at the plant as well as what level of performance they want to transition too. By knowing this information, the team can focus on the conveyance of that information which will bring about that change. Frequently this will be through the …

  • Risk Management as part of your Lean Compliance Strategy to enable you to meet your Compliance Obligations.

    … strategy is a must today. This type of approach helps to define exactly what’s required to provide the appropriate level of coverage to assure compliance and meet the needs of ICH/FDA and other international regulations & guidance’s as well as maintaining a competitive edge to assure your company’s leadership position in the market place. Through the application of Lean Compliance, you can meet your regulatory obligations and maintain your competitive edge! A good example to illustrate …

  • Lean Manufacturing for the Competitive Edge

    … manufacturing:  continuous flow in production, continuous improvement in production processes and quality, and a focus on value for the customer.  The results were impressive: Changeover time on certain production lines – 50% reduction Inventory costs related to production – 30% reduction Plant-level operating expenses – 20% reduction By implementing lean manufacturing’s pull system and using value-stream mapping as its main tool, Merck improved the efficiency and speed …

  • The Right Sequence for Lean Manufacturing Implementation

    … really over. [It] is a continuously ongoing journey that requires management attention on each level.” He further states, “To get buy-in on all levels in an operational excellence program it is mandatory that people understand the meaning and objectives of the program. . . . This will ensure that the program is seen as improving the survival and competitiveness of the plant.” Smart Consulting Group has qualified pharmaceutical consultants with extensive industry-specific …

  • The Drive Behind Lean Manufacturing Implementation

    … on this earlier experience and, having shed certain false assumptions, are again taking up lean manufacturing. Here are a few of the more common false assumptions: · That employees would readily, willingly, and fully accept lean practices, and from that would flow vastly improved production within a short time · That implementing lean manufacturing wouldn’t require the attention of top-level leadership, but could be turned over to plant managers · That lean manufacturing principles could be …

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

    … checking your files.  The inspector will fill a Notice of Inspection (FDA Form 482) and will hand it to you. 1.The inspector will begin by determining the nature of the investigator’s conduct of the study.  He may want to tour the facilities and talk to everyone who took part in the study. His intention is to establish the level of delegation of the investigator’s authority, where specific procedures were performed, where and how the data was gathered, and where the drug was accounted …