ComplianceOnline training

This System Based Inspections training will give you a comprehensive overview of all aspects of systems based inspections covering Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling and Laboratory Control. Development and launch of a new drug product is a time consuming and expensive undertaking. Countless man-hours and multiple millions of dollars are invested in design, construction, equipment, commissioning, validation, and testing. To protect your investment, preparation for the Pre-Approval Inspection (PAI) must be a key part of any drug launch strategy. The entire course is designed to provide you an understanding of how the FDA conducts systems based inspections, and will review examples of FDA 483 observations, so you can better prepare for your Pre-Approval Inspection.

This comprehensive FDA inspection training package consists of five training webinar recordings covering everything from preparing for FDA inspections to responding to FDA Form 483s and warning letters. Are you sure you`re prepared for an FDA inspection in the new future? Do you think your personnel have received enough training to properly get through an FDA inspection? To help FDA regulated companies prepare for agency inspections, we have created a comprehensive training webinar recording CD package covering areas such as the ground rules for handling and FDA inspection; what to expect during an inspection; tough cGMP inspections; the FDA’s new Part 11 inspection program; and responding to FDA Form 483s and warning letters.

Validation and use of Microsoft Excel Spreadsheets, Good documentation practices, Using Styles in Microsoft Word, Reducing the cost of creating documents.