Tag Archives: Plans

  • WHO Ebola Vaccine Meeting

    … many complex policy issues that surround eventual access to experimental Ebola vaccines. Ways to ensure the fair distribution and financing of these vaccines were discussed in an atmosphere characterized by a high sense of urgency. This sense of urgency was conveyed in many ways – from Plans for the different phases of clinical trials to be performed concurrently rather than consecutively, to suggested partnerships for expediting clinical trials, to proposals for getting all development …

  • Value Stream Mapping

    … wouldn’t begin sewing pieces of fabric together without first strategically designing what it is she Plans on making. In any process, it’s vital to understand what it is you are trying to achieve first and foremost. In lean biomanufacturing this is called the future state map. The future state map should identify the condition that is most ideal for your team within your process. Note: You must be able to achieve this condition, or in other words it should be realistically attainable. …

  • Kaizen Events

    … goals and understanding if they have been met, as well as stating the Kaizen implementation results and standardization Plans. These events are no easy feat, so when they are complete, be sure to celebrate and congratulate your fellow research team, while also running with the momentum of your success to help with your next round of developments. Good luck and happy researching! For more information on Kaizen events and lean biomanufacturing as a whole, refer to Dr. Nigel J. Smart’s …

  • Change Management; A Vital Part of the Lean Mechanism within the Life Sciences Industry.

    … and before any deployment Plans are finalized. Often this is best performed by an outside group such as a pharmaceutical consulting company, because this allows for a more objective assessment to be developed. One key point to address is to define for the workforce what the new “Desired State” for the company looks like. It’s very important that the management and workforce clearly understands what they are working towards and how they know when they have arrived at that point. Goals and …

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

    … this is the Risk Assessment of environmental  monitoring Plans to determine the appropriate level of sampling required to assure environmental control while staying within the requirements to operate an effective program. Studies indicate that savings for modern biotechnology production facilities can be in the millions of dollars per annum due to the reduction in testing materials, testing and labor required to collect and test the samples. Determining sample Plans using a simple Risk …

  • Management Responsibilities and Automation Techniques in Regulated Pharma Environments as Per a Suggested Quality System Model

    … technology that simplify the identification of Quality System deviations and nonconformance events, as well as sophisticated auditing capabilities, and should allow for the effortless creation of reports that show data trends. With good automation technology in place, management will still hold the major responsibilities in regards to Quality System maintenance, but timely and uninteresting administrative chores disappear from the picture. -Second responsibility: “Quality System Plans …

  • What You Need to Know About Vendor Audits

    … strategic imitative Plans in recent years.  This system of vendor auditing is being used by different companies, in different industries all over the world, but has really gained ground as a reliable business principle in the pharmaceutical industry. The FDA requires that all inherent systems used to support agency regulated activities need to be validated and compliant with FDA rules and regulations.  In more precise words, the system administrator is responsible for demonstrating that the …

  • 5 Important Factors to Measure in Your Lean Process Strategy

    … other successful quality improvement techniques that may not be found in the standard Lean list of quality procedures. 5.Develop and Initiate the Plans When you have a clear broad overview of your organization, as well as the proper procedures and quality improvement Plans you’re wishing to administer, you can begin to plan out your course of action.  When implementing your plan on sustaining Lean improvements you need to gain the management’s commitment, as well as identify the key …

  • What the New Health Care Overhaul Means To You

    … these new laws will affect your current health care plan.  While there is still no consensus on this matter, many in the pharmaceutical industry like manufactures, pharmaceutical consultants, even doctors do not feel this will affect your Plans in any way.  Many news reports about this health care bill, they feel, have been distorted in the way the spirit of the bill was intended. Many believe that , not only will this new health care reform not change your existing insurance, it will be a …

  • Key Elements of a Business Plan for a Pharmaceutical Business

    … out Intellectual Property Plan is also a basic requirement for any pharmaceutical business.. Plans for a strong patent position in addition to other strategies to protect critical intellectual property must be built into your business plan so that  investors can have a high level of confidence. Another critical element of your plan is your “Go-to-Market” section; this details how you are going to promote, sell, and distribute your new product to the world. You need to describe your …

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

    … identified, a plan to take advantage of them should be created. Threats could include clinical trials in this area by other competing companies, new regulations that would make it difficult to get approval, adverse press garnered by any preannouncements of what you are working on, or a loss of any type of funding for the project.  Threats may or may not be real – but contingency Plans to address them should be in place. A SWOT analysis of your main competitor’s position is an opportunity to …

  • REMS Risk Management Strategies

    REMS is a recent and emerging regulatory requirement for all pharmaceutical companies, whereby the FDA expects these companies to monitor, submit Plans, and proactively manage any and all safety risks in the sphere of their companies’ operations.  REMS stands for Risk Evaluation and Mitigation Strategy required for pharmaceutical and biotechnological companies.  Common REMS issues include drugs with abuse potential, risk of Qtc prolongation, drug-drug interactions, drugs with the risk of …