Declaration Web-based Seminars

Residual Risk and Risk based Verification Learn how define the residual risk of your device and how to streamline the verification process by employing a risk based approach.  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ...ulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed. Why you should attend: Increasingly U. S. companies are going global and must meet different product design documentation. The cGMPs  more...

XML Training ...t is DTD? Why use DTD? Declaring a DTD Types of DTD Declaration Internal External Building blocks of XML 12. INTRODUCTION TO XML SCHEMA What is XML Schema? Example of XML Schema Comparison with DTD Why use XML Schema? Pre-requisites for XML Schema 13. USING SCHEMA WITH XML Sample XML file Sample Schema file Reference to XML schema Using Schema in XML file  more...

The DHF Technical File and Design Dossier - Similarities Differences and The Future - Webinar by GlobalCompliancePanel This webinar will examine the existing and proposed requiements for the FDA's DHF and the MDD's TF/ DD. Differing purposes / goals. Differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update. Similiarities and differences, and future trends. Typical DHF Table of Contents. Technical File or Design Dossier Table of Contents. The importance and  more...