Tag Archives: report

  • 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 …

  • New Data on the Inspection of Human Cell & Tissue Products by the FDA

    A recent report charting inspectional information by the FDA for human cell/tissue therapeutic products shows a marked increase in inspection activity. The period covered is 2003-2010 and reports an increase in the number of inspections by about 250%, with an average duration of each inspection of 40-45 hours. During that period, voluntary compliance actions taken by companies as a result of inspections has increased 255% and official action taken has increased 240%. This is against a background …

  • Pharmaceutical Consultants Broaden the Scope

    … this deadly attack. Still, because we lacked adequate preparedness at the time, the terrorists were able to transform our pork chops into lethal weapons and take the lives of many Americans. Today, however, we are ready for another terrorist attack by the H1N1 virus. Does that sound ludicrous or far-fetched? Really? The August 2010 report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza, professes to provide …

  • Qualified Lean Manufacturing Consultants: Make or Break

    … that closely parallels the final segment of drug manufacturing. In an article titled “Lean Manufacturing for High-Speed Production” (AutomationWorld.com), Wes Iverson underscored the necessity of using qualified consultants. First, he cited some startling statistics: 25% of companies that have implemented a lean manufacturing process (or Six Sigma) report “some progress”, but only a slim 2% report anything close to outstanding results—which means that almost 75% fall …

  • Pharma Sales Reps Facing a Hostile World

    The medical world is showing its ugly, hostile face to pharma sales reps.  The number of doctors that are willing to meet with pharma sales reps on a regular basis is dropping alarmingly, and the group that doesn’t want to meet with them at all is growing even faster. ZS Associates, a marketing consulting firm, has issued a report showing that just 58% of doctors are open to reps, meaning that they meet with 70% of the sales people who visit them.  This percentage shows a drop of 18% …

  • How to Perform a Mock Audit

    … team and others who witnessed the activity. -Input from the participants about what happened during the audit and about the value of the activity. -The creation of an action plan to take care of compliance issues and organizational deficiencies that surfaced during the exercise. -A follow-up report to make sure the action plan is put into practice. Take advantage of the debriefing process to ask the participants about any negative feelings that came up during the mock audit.  A mock inspection …

  • REMS Risk Management Strategies

    … hepatotoxictiy, just to name a few.  These risk management programs may also include elements to assure safe use, a proper implementation strategy, assessment tools, and a clear timetable for the submission of assessments. A REMS report is required for any pharmaceutical and biotechnological company that has been notified during an FDA review, that their products will require preliminary safety testings, because of stricter FDA safety concerns.  Simply stated, REMS testing is the method in …

  • Building an Optimal Quality System

    … reliable quality system breaks down into the following 5 steps: observation of the quality system, identification of deviations and nonconformance events, report, proper analysis, and taking the appropriate action.  It is vital that management have clear responsibilities when covering all aspects of system maintenance including data analysis and reporting any irregularities in the system.  While it is common for quality system managers to spend most of their time and energy on the stages with …

  • Failing an FDA Inspection

    … closely scrutinized than it would have been during the first inspection.  They will also want to verify any new data you may have, including any revised procedures, and may even visit the clinical investigators working for you.  They will want to check, and double check all the company information and data registered by your clinical investigators very closely, and make sure there is no discrepancy in either report.  Failing an even more scrutinized inspection can further lead to more …

  • FTC Commissioner Rosch Will Speak at ACI’s Pharmaceutical Antitrust Forum

    … General’s Pharmaceutical Sector Inquiry report adds a more global scope to this dense field. The Director of the FTC’s Bureau of Competition, Richard Feinstein, along with FTC attorneys Markus Meier, Assistant Director of the Health Care Division, and Michael Moiseyev, Assistant Director of the Mergers l Division, will speak at this event, which is recognized as the place where the leading antitrust authorities meet every year to discuss their upcoming enforcement plans.  Also participating …

  • The Global Vaccines Market, 2008-2023

    From 2008 until 2023 there will be an improvement in vaccines, and their sale and use will experience a rebirth.  Vaccines will be one of the fastest growing areas of the pharmaceutical industry, and their profits will increase by the hundreds in percentage terms during this period. The Global Vaccines Market, 2008-2023, is a report that describes the market trends in a qualitative and quantitative manner.  Vaccines have grown in importance in developed as well as developing countries because …