Tag Archives: questions

  • Best Practices of Smart Consultants

    … assignment, but we advise against the long-winded lectures. What to do if this sounds like you: Be the action maker, the one who raises the questions that no one else may think of right off the bat. Take your love of the industry and channel it into thought-provoking suggestions to better move your team forward. Your team and client, for that matter, will thank you! If you’re not the professor of your squad, but have a secret desire to constantly fact-check your team you run into a whole new …

  • Value Stream Mapping

    … When it comes to optimizing the value stream map, one must analyze “the map for waste wherever the flow is less than ideal/perfect.” Asking better questions throughout your research process will help to more easily identify the non-value-added functions and extract it out to produce more immediate results. Evaluating the Current State through value stream mapping and questioning the major steps will be of most benefit to you and your team’s research. For a more in-depth look at value …

  • Fishbone Analysis

    … otherwise known as the ‘5 Whys’ Analysis. Create a list of “Why 1, Why 2, Why 3, etc.” Then next to each item, identify the problem and then describe why that particular result occurred. Asking sequential questions, while filling out additional bones of the fish structure for each sub-reason, provide a fantastic “checks and balances” system for researchers. For additional information, including case studies on fishbone analysis, refer to Lean Biomanufacturing by Dr. Nigel J. Smart. …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    … together to achieve goals. Asking questions, requiring solid references, and carefully examining track records can go a long way toward ensuring the fit that ensures success. 7. Willingness to Build Relationships Consultants are not just contractors who are called in to do a job, and then disappear when the job is finished. Good consultants have to be willing to establish long-term relationships. The right pharmaceutical consultant for your company is the one willing to establish a relationship …

  • Avoiding the Pitfalls of Pharmaceutical Consulting

    … in finding the right consultant to move your organization from the starting point to the desired goal. Make sure the knowledge and experience are there. Another important step is to make sure the prospective consultant has the necessary expertise – in the form of knowledge, experience, and qualified personnel – to do what you need them to do. Read their publications, check references, and scrutinize track records. Ask lots of questions. Ask yourself and the prospective …

  • FDA Inspection Wizard: What’s Scary Can Turn Out to Be a Piece of Cake

    … -Laboratory certification documents -Drug accountability records -Each subject’s signed informed consent -Assess support areas, like pharmacy or lab, to make sure they are properly prepared.  The FDA may tour the facility Be ready to answer these questions: –    Where was the study done? –    What special equipment was used? –    Who assisted in doing the study? –    What were each person’s specific responsibilities? –    Describe the …

  • How to Perform a Mock Audit

    … that will participate in a specific study. First, choose a location and a study, and later develop a plan for your mock audit based on your SOPs and on the right FDA compliance program manual. This plan should clearly state: -The audit’s goals -The project and location you chose -The participants -The time frames for completing the audit Be very diligent when addressing the requests for information that the mock inspector will issue, taking into account the significant questions about …

  • 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”, …

  • Guilty as Charged: The Premature Stop of Clinical Trials Exaggerates the Effects of Treatment

    … earlier, since it would reach the market faster. Dr. Montori explained that almost everyone doctors, researchers, investors, pharmaceutical firms, scientific journals, and even reporters benefits from the premature stop of a clinical trial; the only one that is affected is the patient, because he or she may wind up being treated with a therapy that is based on deceptive data in regards to its benefits. The study investigated 63 medical questions about 91 trials that were stopped and compared …

  • What the New Health Care Overhaul Means To You

    … individuals competitive health policies for businesses or individuals that don’t have coverage.  Lifetime and annual limits on coverage will also be eliminated at this time.  Other stipulations include, starting 2014, that any persons who do not obtain coverage will have to pay a penalty of either $95 or 1% of their income, whichever one is the highest. While many of these stipulations are real positive steps toward true health care reform, one of the main questions being asked is how …

  • 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 …

  • Compliance Tips For cGMP Inspections

    … recent complaints, production records, and possibly storage and shipping records as well.  All employees should cooperate with the investigation in any way they can, while assuring that their conditions meet your proper code of conduct that you have set forth.  Your company representative must accompany the investigator at all times during his investigation, as well as keep detailed notes, including record of dates, times, areas inspected, questions or remarks from the investigator, and any …