Tag Archives: type

  • Fall Networking Event, a Success!

    … 25-30 attendees! It was an amazing way to connect with business professionals from a wide array of industries, opening up the SCG network beyond the life sciences industry. We’re excited to announce that this is just the start of happy hour/networking events of this type for SCG. We are already in the works of planning our next networking event in the borough, so stay tuned! We appreciate all of the support we get from the local community and we only hope to expand our community reach with the …

  • Kaizen Events

    … concept to take away is that each person involved in these events plays a key role in its process. In the pharmaceutical industry one accomplishment is only the next “go ahead” to the next big idea and so on and so forth. Although time consuming, high-detail follow-up work is a must in order to best monitor and fine-tune each method. It is with this type of work that you will see adequate success with Kaizen events. Let’s first just rewind a bit and explain what is involved with a Kaizen …

  • Venturing into the Bold World of Combination Products

    – By Michael Hemenway For a traditional medical device company contemplating a decision to develop a combination drug-device product, the question of whether or not to pursue this type of product should be weighed carefully.  While there might be a benefit to the patient from such a product, the benefit should be compelling and perhaps more importantly from a business perspective, the profit uplift from having a drug associated with the product should be large enough to more than offset …

  • 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 …

  • Metrics and their Importance in Lean Biomanufacturing

    There is no doubt that metrics are an important component of any well run pharmaceutical process. Without knowledge derived from the data that details the critical process parameters, it is like running blind into a storm without a compass or GPS with which to navigate. Modern biopharmaceutical processes are extremely complex and require synchronization of many process parameters. Without this attention to detail, it is impossible to generate the type of operating capability that produces a …

  • 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 …

  • 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 …

  • Diabetes Trends Until 2025

    Diabetes is a chronic metabolic disorder that develops because the body is not able to produce the hormone insulin and/or is unable to respond effectively to the insulin that is produced. There are two types of diabetes: -type 1, which accounts for 5 to 10% of worldwide diagnosed diabetes cases. -type 2, which accounts for 90 to 95% of the totality of diagnosed cases. The treatment for type 1 diabetes depends on diabetic medical supplies, above all, diabetes drugs and insulin, while type 2 …

  • How to Perform a Mock Audit

    After you have defined the educational programs and standard operating procedures (SOPs) for government inspections, it is wise to choose several studies to apply to a mock audit. You can base your selection on the criteria established by the FDA and on the type of work your company does; for example, a good option would be a crucial Phase 3 study that was recently completed and includes a good number of subjects, and it is also important to consider the accessibility of the data and the staff …

  • How to Do a SWOT Analysis as Part of a Business Plan or Business Process Strategy

    There are many types of analyses that help to illuminate potential issues as well as areas of opportunity for a new business – one is known as a SWOT or Strengths – Weaknesses – Opportunities and Threats analysis.   This type of analysis forces the executive team of any pharmaceutical company to brainstorm these critical items before launching a new company, new division or new product – which may help decide whether or not to venture into this new direction. Strengths are attributes …

  • Building an Optimal Quality System

    … the heaviest burden, mainly steps 2 and 3, managers need to address all stages with appropriate time and energy. Any life sciences consulting firm will tell you that a quality system, regardless of its type or complexity, is never fully an entity unto itself.  For any quality system to work correctly it needs to have managers on site that are not only familiar with the system, but are dedicated to its maintenance and ongoing success.  This is why it is critical that any quality system plans …

  • How to Prepare Your Company for an FDA Inspection

    … advance and can be a great advantage to your company when preparing for the inspection.  Also, doing some preparation on the FDA inspection procedures will enable you to feel more confident when the inspection comes around, as well as give you an element of control over the situation.  Whatever type of questions may be asked, you’ll be ready for them. Another smart thing to do is to have a trusted note taker alongside of you during the entire length of the inspection.  This is important …