GlobalCompliancePanel

Drug companies face many challenges in pediatric clinical research. Pediatric trials come with a high level of complexity and cost.

In September of 2006, the FDA published the Quality System Approach to Pharmaceutical Good Manufacturing Practices which provided a quality orientation to the GMP's

This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.

This course provides the attendees with the tools needed to understand and implement acceptance sampling.

Overview: Pharmaceutical products are ultimately released to the consumer based on a certificate analysis generated by laboratory testing.

It's important to improve the dialogue between financial, quality, IT and environmental management systems.

Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

With the advent of the Sarbanes-Oxley Act, audit committees are under increased scrutiny for helping management set the tone at the top and ensuring internal controls are documented and tested.

Overview: This program will focus on the basics needed to perform an API audit. Performing an audit is not simply an act of visiting a firm and checking off a list of questions.

IEC 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology.