Tag Archives: letter

  • SCG’s thoughts on the last 10%

    For the Pharmaceutical industry, it is difficult for consumers to tell the difference between an excellent, acceptable or poor quality product.  For this reason, safety, quality and reliability problems can go undetected  until the FDA detects them during an inspection or after investigation for a product recall.  By then, the problems can be out of control and can result in a Warning letter or Consent Decree. The below excerpt can be found here: “ // // Seth’s Blog: The …

  • 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 …

  • Bottlenecking Theory

    … Preparation and planning is key in any industry. The best researchers understand that problems or unforeseen issues happen and accounting for those in your team’s earliest stages distinguishes the most successful teams from the not-so-successful. We can’t discuss potential problems or issues without mentioning the four letter word that overwhelmingly plays a major factor in anyone’s research…C-O-S-T. Rid yourself of any potential economic woes by creating a pilot engineering study or a …

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

    … the subject had the medical condition under treatment and that excluded medications were not given to him or her during the study period. 3.After finishing the audit, the inspector will meet with the investigator to talk about the results.  Any inconsistencies will be registered on FDA Form 483, of which you will receive a copy. 4.The inspector will write an Establishment Inspection Report (EIR) that will be sent to the FDA for evaluation.  You will receive a letter after this evaluation is …

  • AAI, CONSUMER GROUPS ENCOURAGE CONGRESS TO BAN PATENT SETTLEMENTS AND RESTORE COMPETITION IN MARKET FOR GENERIC DRUGS

    … PATENT SETTLEMENTS AND RESTORE COMPETITION IN MARKET FOR GENERIC DRUGS FOR IMMEDIATE RELEASE CONTACT:    Bert Foer, 202-276-6002 bfoer@antitrustinstitute.org (WASHINGTON, DC)  The American Antitrust Institute (AAI), along with Consumers Union, Families USA, The National Legislative Association on Prescription Drug Prices, Consumer Federation of America, US PIRG and Community Catalyst, sent a letter to Speaker Pelosi and Majority Leader Reid today urging Congress to include a ban on exclusion …

  • Careers at Smart Consulting Group

    We are always looking for talented experienced people to join our consulting team. At Smart Consulting Group our goal is to attract the right blend of talent & experience to meet the needs of our customers. If you feel you’d like to be part of a winning team and want to consult in the Life Sciences, then please direct your inquiry together with a resume and contact letter to us at inquiries@Smartconsultinggrp.com, alternatively, applications can be mailed to the Human Resources Manager, …