Tag Archives: staff

  • Lean Approaches in Bioprocessing to Help Minimize Variability in Production Yields

    … often hard in practice! At the downstream chromatographic separations part of the process there are many areas which introduce variability into a process. Here we provide some guidance on 7 key areas which are important for a successful Lean bioprocessing strategy. 1. Standardize the packing of the columns using a very tight and monitored procedure. Only use experienced staff to perform this function. 2. Make sure that the system suitability is established and running in a stable mode before …

  • Pharmaceutical Consultants Broaden the Scope

    … Finally, all of the Administration’s efforts to improve the Nation’s capacity to respond quickly and effectively to the next influenza pandemic should be closely monitored by the White House, especially by the staff of the National Security Council. (xii) This passage evokes images of high-ranking generals and government officials huddled closely together, brandies at their elbows and cigar smoke hanging heavily in the air, hammering out strategies, tactics, and counter-measures. Now, is …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    … situation. Instead, what is needed is for your consultants to look at the problem(s) from every possible angle and perspective, analyze and test ideas, and then develop multiple potential solutions. Then, together, you can decide which solution will be the best one – not only now, but also in the long run. Flexibility doesn’t end there, however. For example, the project associates with Smart Consulting can even work as substitute staff and as temporary team members if need be. 4. …

  • 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 …

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

    … systems model proposed by the FDA is divided into four major categories: 1.Management responsibilities 2.Resources 3.Manufacturing operations 4.Evaluation activities Here, we’ll discuss the first category, Management Responsibilities, and how many administrative chores related to pharmaceutical Quality Systems management could be automated. According to the Quality System model proposed by the FDA, management staff in pharmaceutical environments has two main responsibilities: -First …

  • How to Get Through a Successful Pre-Approval Inspection

    … more difficult questions, as well as cause them to look into areas they may have overlooked. This is why any personnel staff that could potentially come in contact with an inspector, should be thoroughly trained and briefed well ahead of time, to avoid any possible problems.  Your personnel should be instructed on how to conduct themselves around inspectors appropriately, as well as how to appropriately answer questions.  Phrases like “I guess”, “normally”, …

  • 5 Important Factors to Measure in Your Lean Process Strategy

    … gathering data about the different aspects of your company, make sure to take precise notes on all company information and material flow. 2.Determine Your Future State Workflow Your future state workflow is dependant on your product, as well as your process layout.  For many organizations, developing the most efficient workflow strategy possible is the best way to organize your staff efficiently.  For many organizations having a streamlined workflow makes the whole process easier.  What you …

  • What You Should Know About Your cGMP Inspection

    … inspection.  They will be ready to instruct you on the best inspection readiness strategies, as well all the cGMP guidelines and restrictions you should be aware of.  They will also help to train your staff, so that they are better suited to answer questions effectively during your cGMP inspection.  Adequate preparation cannot be delayed until the last minute when preparing for your cGMP inspection. Your company will need at least 6-12 months of preparatory planning. It is important to …

  • CDER’s Small Business Assistance Bulletin

    … submit to the FDA at the conclusion of the workshop. To help participants develop strong applications, FDA staff will provide one-on-one regulatory help. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm195343.htm 7. FDA/DIA 5th Workshop in a Series on Pharmacogenomics: Generating and Weighing Evidence in Drug Development and Regulatory Decision Making, February 2-4, 2010, 5701 Marinelli Road, Bethesda, MD. Meeting Information and registration/ 8. DIA/FDA CDER/CBER Computational …

  • What a Life Sciences Consulting Firm Can Offer Your Business

    Oftentimes, one of the hardest tasks for a pharmaceutical or life sciences firm to achieve is not necessarily starting a successful business, but maintaining a successful business.  This is mainly because the life sciences market is extremely competitive, and so much depends on the efficient use of resources, as well as staying current with the newest technologies and methods of production. For a smaller pharmaceutical company, this task can be even more daunting, as budget and staff …

  • FDA Resolves Compliance Issues with Drug/Device Combination Products

    … applications for combination products usually work for clearance. Dependent upon the combination product, the FDA may recommend two separate marketing applications. The FDA advises applicants to contact the OCP to discuss the appropriate marketing application based upon their drug/device combination. Pharmaceutical consultants agree that the FDA’s OCP has made great strides over the past few years with compliance issues for drug/device products. The OCP conducts trainings for both staff and …

  • Preparing Your Company For an REM Evaluation

    … that optimum quality for all drugs released or they will not go into post production.  Most REMS programs use web-based technology, augmented by printed materials and a very informative call center staff that can help you with any problems you might be having.  These new systems allow the FDA to amass incredible amounts of information from which FDA reports are generated, tracking product usage rates, as well as educating participants and giving them timely reminder notices. If you are …