Design Control Web-based Seminars

Verification vs Validation in Regulated Industries - Webinar By GlobalCompliancePanel Overview: Attend this webinar to understand the differences and benefits of verification and validation. Learn about the risks and complications involved with the application of sound verification and validation principles. Thursday, March 1, 2012 10: 00 AM PST | 01: 00 PM EST  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ...different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier. Currently they serve different purposes, support different goals, but the TF/ DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of  more...

FMEA and Risk Management for Medical Devices - Webinar By GlobalCompliancePanel Overview: This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture. FMEA (Failure Mode & Effects Analysis) is only a segment of Risk Management, but quite valuable for assessing Risk as part of Risk Management. Now that EN 1441  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel Overview: ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: 2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to  more...

Bringing Compliance To Design Control For Older Products - Webinar By GlobalCompliancePanel ...design control after product release including: design change control, design validation, and the Design History File. The webinar is designed to help regulatory Affairs, Quality Engineers, and Design Engineers maintain released products within current regulatory requirements. As an attendee you will learn what the FDAs expectations for your released products are. You will also learn about  more...

Design Control for Medical Devices - Webinar By GlobalCompliancePanel ...ocess must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction. This webinar will cover the basics of design controls, and provide recommendations for implementation of a compliant design control system. Also discussed will be design control  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...trol * Regulatory / FDA 483 a Hot Buttonsa * Design Control * Document Control * Identifying changes * Preventing negative changes * Maintain a 'state of control' * Business needs and obtaining 'buy-in' Who Will Benefit: * Senior management in Drugs, Devices, Biologics, Dietary Supplements * QA * RA * R&D * Engineering *  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...ule 3: Management of Documentation and Records Module 4: Design Control Module 5: Facilities, Equipment & Environment Module 6: Material a Purchasing Controls-Specification, Qualification and Control of Suppliers, and controlling incoming materials Module 7: Technical and "Administrative" Process Controls Module 8: Introduction to Deviations & Quality Failures (0: 10) Module 9:  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...10(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820. 30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions.  more...

Managing the IDE Investigational Device Exemption Submission for Compliance Success - Webinar by GlobalCompliancePanel An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to  more...