GlobalCompliancePanel

The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing.

The FDA generally defines combination products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product

This 3 hour Webinar is a primer and overview to the premarket notification process, i.e., a 510(k).

The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR)

New regulations modifying the HIPAA Privacy and Security Regulations have been proposed and/or finalized to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009.

Learn how to Use excel spreadsheet for GXP data and reduce validation cost and time. Configure Excel for audit trails, security features, and data entry verification.

This webinar will describe how to conduct a thorough drug safety and pharmacovigilance audit, including compliance with applicable worldwide laws, regulations and guidance. In addition,

As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly.

Within the next few weeks and months the FDA will conduct a series of Part 11 related inspections.

Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization approach,