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TRAINING

GLOBAL QUALITY AUDITS AND REGULATORY COMPLIANCE SERVICES

All quality management systems require (a) established and maintained written procedures that include internal and external requirements; (b) implemented written procedures by top management that are followed and documented by trained personnel; (c) a corrective actions and preventive actions system; and (d) continuous improvement.  However, problems occur whenever there is not a balance between internal goals and objectives and external industry and governmental laws, regulations, directives, standards, and/or guidance.  One way of meeting both internal and external requirements are to have properly trained and/or qualified personnel.

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Not only are iCAN GMP professionals equipped to oversee and/or perform any and all of your training operations but also act as your quality, regulatory, and operational managers and/or personnel until you have proper personnel and organizational resources to meet all quality management system requirements.

INSPECTION READINESS AND ON-SITE SUPPORT

Just like local cops and judges, state, regional, and federal governmental agencies assess whether you meet their applicable agency laws, regulations, directives, standards, and/or guidance. Except for FDA medical device and clinical inspections, all other FDA inspections (such as pertaining to foods, cosmetics, pharmaceuticals, biologics, and tobacco products) are currently unannounced.  Similarly, depending upon the product type and/or risk, other governmental health agencies and their approved agents (such as EU notified bodies) may also have unannounced audits as well.  The same is true for non-health agencies (such as U.S. Consumer Product Safety Commission pertaining to various cannabis products).

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Will you be ready when these governmental employees knock at your door to assess your quality system per the applicable agency laws, regulations, directives, standards, and/or guidance?  If not, not only will there be various enforcement actions (such as from warning letters to product seizures and prosecutions), but your company will also have:

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  • Loss of resources;

  • Loss of sales;

  • Loss of face;

  • Disgruntled and/or loss of employees (including whistleblowers);

  • Loss of suppliers and customers;

  • Decreased competitive advantages;

  • Lawsuits and other liabilities; and/or

  • Increased corrective action costs (including costs associated with recalls and product and/or process changes and the hiring of consultants).

Image by Ruchindra Gunasekara
Image by Dylan Gillis

Do you want to roll the dice and hope that you are never caught (which you eventually will be… thus it might be too late for you… have fun making license plates….) or take the high road and be preventive?  How to be preventive?

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Easy… have iCAN GMP professionals assist you and your team prior to, during, and after local, state, regional, and/or federal audits, inspections, and investigations.  Not only were we ex-governmental investigators (i.e. who know the secrets and tactics of your friendly governmental and industry approved auditors, inspectors, and investigators), but we have extensive indystry experienced too (such as worked as quality, regulatory, and operational managers for various U.S. and international companies).

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