Conformity Web-based Seminars

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ...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 mandate Design  more...

Medical Device Classification - Webinar by GlobalCompliancePanel ...I). The risk class of the device determines the available conformity paths the manufacturer may use to affix the CE mark. This webinar explains the risk classification and conformity paths using the MDD version in effect after March 2010. The Canadian Medical Device Regulations (CMDR) classifies devices into four risk categories (I, II, III, and IV). Classification follows a rule based  more...

Outsourced processes and ISO 90012008 - Webinar by GlobalCompliancePanel ...The changes clarify the organization's responsibility for conformity to all customer, regulatory, and statutory requirements. The changes reinforce the need for control over outsourced processes and recommend using the methods found in the ISO 9001 Purchasing clause. These changes also include suppliers who are part of the same parent organization, such as a separate department or division.  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...