Medical Devices
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Using Metrics to Monitor and Improve Your Quality System
Description: Medical Device companies need effective metrics and dashboards to ensure they are proactively and consistently meeting the needs of all their stakeholders: Customers: It is critical to maintain metrics to ensure that your customers are receiving safe and... -
Transferring Medical Device Production to a Contract Manufacturer – Decision Making Process and Procedures
Description: This webinar on outsourcing medical device manufacturing will discuss practical decision making steps you can follow to analyze whether to transfer or invest in keeping production in-house. If you decide to transfer production, then this training will detail... -
FDA’s New eMDR Requirements
Description: Manufacturers and importers must report adverse events associated with a risk to health or death. Until now, the reports were submitted in hardcopy using MedWatch form 3500A. Managing the volume adverse event reports for industry and the FDA... -
IQ, OQ, PQ in the Verification and Validation Process
Description: This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and CGMP e-records / e-signatures. FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in... -
Medical Device Changes and the 510(k)
Description: This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S. FDA’s current K-97-1 Memo... -
CE Mark: Content and Format for a Technical File and Design Dossier
Description: This presentation is intended to help you get familiar with the European Union (EU) Directives governing medical devices including in vitro diagnostic and active implantable medical devices. This presentation is further intended to provide practical, actionable, and sustainable... -
510(k) Preparation, Submission and Clearance: Dos and Don’ts
Description: FDA recently issued final 510(k) guidance, providing FDA’s policy on the 510(k) program. This webinar will provide great opportunities to get familiar with how to best prepare for a 510(k) for a successful submission and clearance: in particular,... -
Implementing an Internal Audit Program of QMA, Persisting to ISO 13485 and 21 CFR Part 820
Description: This webinar is intended to help you adequately develop an internal audit program of a firm’s quality management system (QMS) as required by ISO 13485 or 21 CFR Part 820. 21 CFR 820.22 states “Each manufacturer shall establish... -
Risk Management – Principles of Lean Documents and Lean Configuration
Description: Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. During all phases of a project,... -
Design Inputs – Design Outputs Traceability Matrix – Principles of Lean Documents and Lean Configuration
Description: Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design... -
Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration
Description: The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems,... -
21 CFR Part 820 – Quality System Regulation – Applying Principles of Lean Documents and Lean Configuration
Description: All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21... -
Advanced Course on Lean Documents, Lean Configuration and Document Control for Medical Devices
Description: In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; Types of controlled documents; examples of lean and non-lean controlled documents; Pros and cons... -
Corrective and Preventive Action (CAPA) utilizing the Principles of Lean Documents and Lean Configuration
Description: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Corrective and Preventive Actions (CAPA) – which is often redundant, repetitive, and chained together in a cumbersome way? Do you find... -
Medical Device Single Audit Program (MDSAP)
Description: Every regulatory and quality professional working for a medical device company should attend this webinar to understand MDSAP objectives, MDSAP advantages and disadvantages and its implications for medical device companies. In 2017, all medical device companies operating globally... -
CAPA – Corrective Action Preventive Action
Description: How CAPA’s are executed and managed is crucial to maintaining a compliant organization. Inadequate failure investigations continue to be a major GMP deficiency and consistently make the FDA’s top five list for adverse observations. This course highlights the...
