Regulatory

This training package features an Adobe Flash training presentation with audio, which provides a strong tool for training a workforce in the fundamentals of current Good Documentation Practices.

This training package features an Adobe Flash training presentation with audio, which provides a strong tool for training a workforce in the fundamentals of cGMP manufacturing.

This training package features a training presentation which provides an overview of various regulations from the Quality System Regulation and the Global Harmonization Task Force which govern the Medical Device industry.

This package features a training presentation that outlines a standard procedure for aseptic gowning, as well as recommended cleanroom behavior for aseptic processing areas.

This package features a universal audit / inspection preparation checklist template which provides a comprehensive list of tasks and activities that should be performed by multiple departments in preparation for a regulatory inspection or audit.

This template package features a universal Training Attendance Sheet template that can be used to properly track and document the attendees of any training course.

This template package features a universal Certificate of Translation template that can be used to properly document and certify any documents that require translation.

This SOP package features a standard procedure that defines a fully compliant GMP documentation system for any GMP facility.

This SOP package features a standard procedure outlining a completely defined and cGMP compliant training system.