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The US Food and Drug Administration (FDA) conducts inspections of regulated facilities to determine compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act as well as related Acts. Such inspections extend to foreign manufacturing and processing sites for FDA-regulated products that are sold in the United States.
 
These inspections can either be a pre-approval inspection pursuant to an application to market a new product, or a routine inspection, or “for-cause”. Inspection observations may result in Warning Letters which could further escalate in automatic detention or even facility deregistration. It is therefore imperative that besides being consistently in compliance & ready for an inspection at any time, facility personnel must know what they are allowed & not allowed to answer; when they should defer questions to their supervisor; and which locations & information they are obliged to allow access to the FDA investigator.
 
Participants will be led by an experienced trainer whom, in addition to being a CE Marking auditor, technical file reviewer and a trained MDSAP auditor, has nearly 3 decades of assessment, training and quality assurance as well as management system development experience. The trainer has also performed Regulatory Authority Inspections in addition to FDA Mock Inspections. Participants will be in a position to gauge the readiness of the plant and to plan for & manage the FDA inspection.

Outline

  • US FDA Inspection Program and Quality Systems Inspection Technique
  • Types of FDA Inspections
  • Preparing & Passing FDA Inspections
  • Proper manner to interact with FDA Investigator
  • Roles & Responsibilities
  • Post inspectional correspondences & other activities
  • FDA Warning Letters Trends
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Ampro believes that the key to a successful and rewarding career is continuous professional development.  We have a flexible approach to your training needs with regardless of whatever your requirements, we promise you a high level of service with packages that meet the needs of your business.

As a forward thinking company we deliver training at all levels, thereby supporting your company at every stage of its development. Courses can be delivered onsite at a location of your choice, costs dependent upon location and numbers, or at hotel.

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We are determined in developing new programmes and staying on-point with industry's trend, while maintaining exceptional quality standards.

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Our trainers and consultants are quality assure and have been tested on their ability to deliver top-quality programmes. ...
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