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

Using a reliable process to meet current quality standards to determine the verifiable causes of problems. Root cause analysis is a systematic method to determine the causes of non-conformances. To meet current quality standards, medical device companies must use a reliable process to determine the verifiable causes of problems.

This webinar discusses the use of risk analysis techniques applied to medical device software including discussions of pitfalls in the process of risk analysis. This webinar will provide guidance to medical device companies that need to perform risk analysis on their software products and internal systems.

This risk-based software V&V training will guide you through 11 "must have" elements of software validation and how to use your Risk Management Tools (per ISO 14971:2007).

The following webinar will cover common CAPA problems across industries and how to avoid them. This webinar will provide valuable assistance to all regulated companies that need to have CAPA systems as mandated by the FDA.

This Corrective and Preventive Action (CAPA) webinar will teach how the risk based approaches be implemented under CAPA.

This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device.

This presentation will review the general requirements for performing EO validations via the "overkill" half-cycle method as described in ISO 11135.

Usability testing on medical device labeling can help avoid these consequences and improve your return on the investment (ROI). Usability testing is a ’Best Practice’ method for assessing the efficacy of your labeling and enhancing its value to your users.

This webinar will provide valuable assistance to all regulated companies, a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. This session will discuss the importance, requirements, and elements of a root cause-based CAPA program, as well as detailing the most effective ways to determine root cause and describing the uses of CAPA data.

This webinar will provide valuable assistance to regulated companies which employ regulatory affairs associates, clinical specialists, internal auditors, audit managers and personnel of JPAL-regulated medical device or IVD companies. A comprehensive audit of relevant clinical investigations is now expected to determine if the clinical trials and clinical trial systems are effectively documented and implemented.

In this webinar, we will review basic FDA expectations for evidence of adequate analysis and testing to identify the severity and likelihood of use errors, and validation of risk mitigations through usability testing with representative users. As applied to the overall Design Controls process phases, will be presented.

This webinar will provide valuable assistance to internal auditors, audit managers and personnel of regulated medical device or IVD companies. This presentation will provide an understanding of the tools of risk management and how to integrate risk management into an effective internal audit program.

The workshop will provide guidance on the roles and responsibilities of each functional area in the company and how they relate to each other. Each company must demonstrate full implementation of the quality system by providing appropriate training and re-training when necessary, for its employees.

In this webinar, essential tactical tools will be discussed in detail with examples of when to apply one and not another The tactical tools will be presented in the framework of an overall regulatory strategy so you can see the “forest for the trees” and effectively communicate your plan to senior management, the development team, and most importantly, to government regulators

This session will introduce advanced control charting for multiple stream processes. We will also introduce control chart analysis and how to select the correct control chart and interpretation and reaction to control chart signals.

The presentation will review the complete requirements for Risk Analysis and give an example of how a company can easily create a Risk Analysis in full compliance with the standard. The information will assist in meeting various national and global regulatory requirements for medical devices.

An overview of the new ISO 14971:2007 standard with emphasis on changes from the 2001 version. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry.

Detailed analyses of the sections of the QSR design control regulations that have requirements not present in the ISO 13485:2003 standard. Many companies are confidant that their ISO 13485:2003 design control system is compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 design control cites are written and warning Letters, seizures or worse ensue.

This Management Controls Under QSR and ISO 13485 training/webinar will discuss the requirements for Management Controls, including organizational structure, internal audits, establishment of a quality policy and confirmation it is being followed, establishment and contents of a quality system and quality plan, and of course all aspects of management reviews.

This Residual Risk and Risk Acceptability webinar/training in medical devices will discuss how to meet this requirement and also how to determine what disclosures of risk need to be made in the instructions for use of the medical device and Proper evaluation of overall residual risk and the acceptability of this risk.