Tag Archives: specific

  • 483 Audit Forms

    … escalation, like a Warning Letter, which is much more severe in nature. Yet, fear not. You will not be left in the dark after receiving this 483 audit form. The FDA will also provide a detailed written report, spelling out the specific reasons for the audit known as an Establishment Inspection Report, as well as all evidence or documentation that was extracted while the investigator was onsite. From there, depending on the severity of the case, the Agency will determine what kind of action will …

  • Risks in Lean Compliance

    … identify potential risks before embarking on any sort of endeavor, especially something that involves time and money for your research team. By ranking and understanding the probability of various occurrences, based on a specific action or step in your process, you will have an overall better grasp on what could potentially cause issues down the line. If you’ve read SCG’s blog on waste removal, some of these concepts may not be unfamiliar to you. When identifying and understanding …

  • Waste Removal

    … specific case, you’re not alone. Many researchers find that some components are just too vital to eliminate. Especially when it comes to raw materials, as it is vital that you deliver and check for defects before they are put to use. With that being said, you cannot always eliminate waste, but you can most certainly minimize it as much as possible. Now let’s get to it. It’s important to first eliminate components in your research that are most easily able to be eliminated, otherwise known …

  • NDC codes: National Drug Codes and How They are Assigned

    … material. The second section identifies the product code which includes the specific strength, dosage form and formulation for the company. The third section identifies the packaging code and this corresponds to the package size and type. This part together with the product code is provided by the company filing the NDC application. In practice NDC codes follow the following convention: 4-4-2, 5-3-2 or 5-4-1, where the second and third parts are determined by the operating convention within each …

  • Lean Philosophy and the Life Science Industry

    … for thorough and comprehensive documentation and independent quality verification. What is required in applying Lean to the Life Sciences Industry is a clear understanding of where regulations require commitments and specific actions even though a value stream analysis may show those actions to cause a bottleneck. Making pharmaceuticals and other Life Science products is a complex marriage of biology, chemistry, engineering and regulatory compliance. Get one of these out of balance and the …

  • Pharmaceutical Consultants-The Key to a Rapidly Changing Industry

    … to adopt pertinent changes so as to remain competitive when the trends are in full swing, thereby applying a type of preventive medicine. Make no mistake, quality pharmaceutical consultants can be an invaluable asset. From developing a relationship built on mutual trust and respect, to their vast industry specific knowledge and analytical skills, qualified pharmaceutical consultants provide the tools and support that enables their clients to successfully manage costs, improve business …

  • Pharmaceutical Consulting and BMI’s 4th Quarter Update

    … comprised of highly qualified pharmaceutical consultants with extensive industry-specific experience who can guide companies through the upcoming years of slowing market growth, and help them sustain profitability. Their goal is to “provide the competitive edge you need to be the market leader in medical products.” …

  • 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 …

  • 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 …

  • Making Relationships Count With Life Sciences Consulting

    … methods are often the same methods used 10 or 20 years ago. Consequently, this strategy very often falls short of achieving the maximum potential value for life sciences companies. Initially, the CMO-sponsor relationship was entered into chiefly as a tactical, specific solution. Later, owing mostly to quality issues that began to crop up, central governance was created. And more recently, in the effort to build global networks, emphasis has been on the supply chain. The dynamics between CMO and …

  • 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 …

  • 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 …