Tag Archives: hand

  • Best Practices of Smart Consultants

    … your project. No one likes gossip. If this sounds like you, you might be the team Gossiper. Focus on the task at hand and do not complain about your fellow consultants to each other. Not only is it unprofessional, but it’s not nice. Why not be a better you this 2015?  Disclaimer: This piece wasn’t meant to poke fun at stereotypes, but rather shed light on personalities that practically anyone, no matter what the industry, can all agree are not acceptable work practices to ensure success! …

  • 483 Audit Forms

    … should not go unnoticed. A 483 audit is issued after the conclusion of an FDA inspection. This form states that certain conditions were cited as “in violation” of FDA standards/regulations. The FDA investigator feels that the practices or conditions surrounding the product at hand is in question and therefore a change needs to be set forth, in order for operation to continue. A company must understand the problem at stake as well as the violations that are in play as a way to avoid an …

  • Lean Manufacturing Solves Drug Recalls and Bad Press

    … new blockbuster drugs, and the cost of bringing new drugs to market running in the neighborhood of $1.5 billion, drug companies are struggling. The opportunity for them to benefit from a new image and from lean manufacturing implementation is at hand. Lean manufacturing techniques do work, but effective implementation in the pharmaceutical industry requires knowledge of the special circumstances that exist in the industry, i.e. the difficulties involved in altering batch sizes, the fact that …

  • The Smart Road to Pharmaceutical Consulting

    … development, managed markets, medical affairs, sales, and trade and distribution. On the other hand, Maxim Group has more of an IT slant, and offers services such as IT strategic roadmap, IT utilization/value assessment, software package selection, software package implementation, and system integration. Then there are the pharmaceutical consulting firms, such as Smart Consulting Group, that fall somewhere in the middle, with their own niche areas of specialization owing to specific training and …

  • 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 …

  • Key Factors in Third Party Testing on Combination Products

    … operation, each FDA product is first assigned to a particular center within the FDA that will have primary jurisdiction over the product.  Combination products, on the other hand are assigned to different centers, based on their “Primary mode of action”, which means their primary purpose.  However, making this determination can sometimes be difficult and confusing. Before these products can be tested either by the government, or a third party testing group, it has to be decided …

  • 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 …

  • New Stem Cell Technology Better Helping Bone Fracture Patients

    Until recently, standard treatment methods for serious bone loss due to bone fractures and bone disorders, have been limited at best.  Standard treatments for serious bone fractures would encompass basically two treatment options: either face amputation, or face long periods of disability.  While prosthetic implants, on the other hand, have proven equally as frustrating over recent years, and are proving more inefficient in the long term.  Because of these problems, something needed to be …

  • Important Information about Lab Ergonomics

    … biological safety cabinets. Here we show you several ways to control some of these risk factors and to ensure your personnel is working in a comfortable, productive, and safe lab environment. 1.    Pipetting This task involves various ergonomic strains like thumb force, repetitive movements, and awkward postures of the wrists, arms, and shoulders.  In order to alleviate these hazards follow these tips: –    Use pipettes that fit comfortably in the user’s hand and that have …

  • Comparative Effectiveness and Health Care Reform

    … power of the public sector.  The big pharmaceutical companies have been attacking this for years, as they fear head-to-head studies would favor the lower-cost treatments over typical, more expensive branded medicine.  While the government, on the other hand, simply sees this as just another way of cutting cost.  The large pharmaceutical companies don’t want these research mandates being the final decider in treatment guidelines and insurance coverage, while the government sees this as …