Compliance & Validation Training

A compliant  Quality System is based on staff training: education represents one of the best way to obtain the so called "Continuous Improvement" of company compliant processes.

K2C training courses include but are not limited to:


*       Pharmaceutical Quality System

*       GMP regulations: basics and application

*       Risk Analysis and Risk Management: methodologies and applications

*       21 CFR part 11: interpretation, application and remediation plans

*       Standard Operating Procedures in a GxP environment

*       IT Security in a GxP environment

*       Project Management: methodologies and tools

*       Supplier Selection and Qualification

*       Validation Lifecycle (processes, cleaning methods, computerized systems, equipment, infrastructure)

*       Knowledge, training and skills mapping

*       Requirements for identification and labeling

*       Validation in a specific regulatory environment (GMP, GCP, GLP, GCLP etc.)

*       Development and Validation of Electronic Document Management Systems

*       Implementation and Validation of PAT (Process Analytical Technologies)

Contact us for more information or to ask for the full list of K2C training courses.