Medical Device Regulatory Compliance Training - Live Webinars, Recordings & CDs

This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.

This webinar will help attendees to understand the quality issues and methodologies that are relevant in current supply chain management to improve your customer satisfaction.

This webinar on dose audit test failure for medical device will discuss the various items that should be investigated to determine the root cause, what are the immediate actions that are required and steps to be taken to evaluate product in the field.

In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.

This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.

This webinar will define human factors engineering and its role in the success of new product development. The session will use real world examples to demonstrate how human factors engineering makes a significant.

This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to controlled document system for a life sciences manufacturing plant.

This webinar on verification vs. validation will help you to understand the differences between, and benefits of, verification and validation in both design and process operations in regulated industries. Learn about the risks and complications involved with the application of sound verification and validation principles.

This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for managing your suppliers. You’ll learn about the essential elements of purchasing control and supplier audit. We’ll discuss the process steps for supplier control and how it relates to other parts of your QMS including receiving and acceptance activities. Also attendees will learn how to prevent quality and compliance problems by having a strong system for supplier audit and management! A well-designed supplier audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk.

A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.

This quality management system webinar will discuss how to implement effectively a Cost of Quality System (Data collection, Analysis and Metrics) using the mechanism of 6Sigma DMAIC. Also this presentation will address costs of failure and costs of appraisal.

This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.

This medical device reporting webinar will guide you to understand best practices to assess your current MDR efforts and implement changes to match the FDA's new guidance recommendations. Attendees will learn the current regulations that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for any device-related adverse events and certain malfunctions (investigational study reporting).

This webinar will help understand data analysis requirements for QSR, the techniques to identify problems, analyze cause and action plan preparation to avoid FDA inspection and MDSAP audits. It will help you understand how to pick right data analysis techniques from ISO/TR 10017:2003 and how to analyze data in excel.

This webinar will highlight the changing circumstances with respect to software regulations and FDA’s approach from a regulation to voluntary standard. How to understand the qualifications and terms of participation to clear its software for marketing, what to do in case of cybersecurity intrusion and how to update regulatory program as mobile apps are removed from FDA’s regulatory oversight.

This webinar will give an understanding of various processes and compliance requirements for US market entry by non-US medical device manufacturer. It will teach how to comply with pre-market requirements, how to get submission & product clearance/approval, what are various activities to be done post market entry of products (surveillance, reporting, audit, correction & removal).

This webinar covers the central role of CAPA for the FDA, challenges in building an effective CAPA system, gives a comprehensive understanding of a CAPA process which is highly effective and sustainable, becoming a tool for continuous improvement. It will discuss capturing and assessing potential CAPA’s, using risk-based assessment, documentation, determining true root cause, how to take preemptive preventive action and using metrics for long-term improvement. The course will also discuss potential changes as FDA considers integration with ISO 13485.

This Water system compliance training cover all these issues and more so that the attendee can have a better appreciation of the endotoxin test, a better understanding of what can go wrong in WFI systems to allow endotoxin into the finished water.

The management responsibility section of the QMS is one of the most important parts because it sets the tone for other sections. If you are involved in any aspect of management responsibility, then you need to understand how to set up the system as well as what can go wrong. This presentation provides you with an explanation of the issues, implementation tools, and illustrations of problems that could arise.

The objective of the Webinar is to teach participants how to use ISO 10993-1 and FDA guidance to establish a proper biological safety evaluation plan, including how to document and implement their plan. It will also cover how to properly complete your biological evaluation report including biological safety assessment as required by domestic and foreign regulatory submissions.