Tag Archives: conditions

  • 483 Audit Forms

    … should not go unnoticed. A 483 audit is issued after the conclusion of an FDA inspection. This form states that certain conditions were cited as “in violation” of FDA standards/regulations. The FDA investigator feels that the practices or conditions surrounding the product at hand is in question and therefore a change needs to be set forth, in order for operation to continue. A company must understand the problem at stake as well as the violations that are in play as a way to avoid an …

  • Pharmaceutical Consultants-The Key to a Rapidly Changing Industry

    When market conditions, and methods of manufacturing, testing, and technology remain virtually unchanged for long periods, companies within that industry generally manage quite well doing everything in-house. However, when an industry finds itself in the throes of rapid and unexpected change, outside experts are often needed to provide the knowledge and expertise necessary for corporate survival. That is exactly where the pharmaceutical industry is, and why the value of pharmaceutical …

  • Qualified Lean Manufacturing Consultants: Make or Break

    … companies have been reluctant to adopt and implement lean manufacturing techniques due to skepticism that production solutions coming from the auto industry can’t really be successfully applied to the special conditions of the pharmaceutical industry. This fear is both justified and unjustified – the difference usually boils down to the use of qualified lean manufacturing consultants with industry-specific knowledge and experience. Here’s an apt illustration from another sector …

  • Pharma Sales Reps Facing a Hostile World

    … indicator for the need of a more efficient sales model, where marketing efforts are adapted to local conditions.  In places where doctors are very unfriendly, it may be more beneficial to establish new strategies like online detailing, for example.  Doctors who want to see reps only once a month should be respected and contacted only within the time frame they consider acceptable. Your pharmaceutical consultancy firm will confirm it; the worse you can do, image, money, and employee …

  • Could a Shot of Tequila Be What People Suffering from Bone Loss Need?

    … Guanajuato, tested the agave fructans on mice bone growth.  The sample fed with agave fructans absorbed more calcium from food, expelled less calcium in their feces, and increased in 50% their levels of a protein associated with the development of new bone tissue, all three, conditions that were not observed in other mice. The natural conclusion is that by enriching the mice’s normal diet with agave fructans, bone loss was prevented and bone formation was enhanced.  This suggests that …

  • What the New Health Care Overhaul Means To You

    Now that  the year long, and oftentimes ugly journey towards health care reform is coming to an end, many are curious as well as concerned about what this health care overhaul means for them.  What we have heard is that this new landmark legislation will extend health care coverage to 32 million Americans who are currently uninsured, and stop insurance companies from discriminating from patients with pre-existing conditions. But what else will this milestone legislation cover? With so many …

  • How Will Obama Care Affect the Pharmaceutical Industry?

    The biggest health care reform act since Medicare was created in 1965 has just been signed by the President– amidst more controversy than any bill passed in the last twenty years.  How will this affect the pharmaceutical industry? This bill is estimated to carry a $940B price tag, but will insure an additional 32M Americans by 2019.  However, it does include hefty taxes – over $70B, and HMOs.   Insurance companies won’t be able to deny new customers based on pre-existing conditions, …

  • REMS Risk Management Strategies

    … There are a number of different conditions in which a risk evaluation may be required.  One of the most common circumstances is when new safety information becomes available about a drug that might result in further testing of the drug’s overall safety.  The FDA might also require that if a group of medications all have the same risk, then those from that same drug class be tested as well.  The FDA may also require a risk evaluation test on new medications if there is any concern about …

  • 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 …

  • CDER’s Small Business Assistance Bulletin

    … designation, for drug products intended to treat rare diseases. Orphan drugs are either drug or biologic products used to treat conditions affecting fewer than 200,000 people in the United States. Orphan drugs may be already-approved or experimental drugs. The workshops will be held Feb. 25-26, 2010, in Claremont, Calif., and Aug. 3-4, 2010, in Minneapolis. At the workshops, participants will propose a specific drug for a specific rare disease and work on an orphan designation application to …

  • Be Prepared When the FDA Knocks on Your Door

    … to see the top management person on site, and he will show his credentials and an FDA ‘Notice of Inspection’ to that person.  Afterwards, a thorough inspection of the facilities will begin, while one or more key employees tag along.  After a few days, the FDA will send an ‘Inspectional Observations form’ to the leadership team informing them about any unacceptable conditions they have found in regards to products, processes, or other violations to the FD&C Act. The results of such …

  • The 6 Crucial Principles in Pharmaceutical Leadership

    … conditions.  In order to synchronize global communication, there may have to be some compromise in terms of standard working practices. –    Awareness.  Some employees may not realize they are a part of a virtual team, requiring training in new ways to work. –    Project phases.  Employees have to be trained in which communication channels work best for different projects and their phases. –    Roles and responsibilities.  Team members must recognize the skills, …