GlobalCompliancePanel

This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data.

As a quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms to the appropriate quality standards to meet customer and user needs.

Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology

This program will provide the content for pharmaceutical manufacturing sites to establish sound quality management system procedures for the disposition of intermediates, API, drug substances, medical devices, finished product

This webinar will cover several recommendations to improve the hospital's Due Diligence when dispensing Schedules II through V controlled substances in a hospital setting and what steps that can be taken to detect and prevent the illicit use

When existing or legacy computer systems are used in FDA or equivalent international environments they should be validated, a process sometimes called retrospective validation.

HIPAA Business Associate rules have changed in fundamental ways, with new responsibilities and obligations for HIPAA BAs.

The new HIPAA Breach Notification Rule required by the HITECH Act within the American Recovery and Reinvestment Act of 2009 went into effect September 23, 2009,

The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion.

The webinar examines critical parts of design control after product release including: design change control, design validation, and the Design History File.