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

This Steam Sterilization training will review the general requirements for performing a steam sterilizer validation via the “overkill” half-cycle method as described in ISO 17665 (supersedes ISO 11134). For decades, steam sterilization (autoclaving) has been an integral part in the manufacturing and laboratory processes in the medical device, pharmaceutical, and HCT/P industries.

This webinar will provide valuable assistance to all FDA and EMEA regulated companies that need to validate their cleaning and disinfection programs.

This class reviews the modular option of filing a PMA and the benefits it offers all companies having to negotiate through the PMA process.

This webinar will provide valuable assistance and guidance to all medical device companies that are preparing and submitting 510(k)s to FDA for review and approval.

The presentation will use examples taken from warning letters to illustrate some of these problems, and discuss possible solutions. As an example, we will discuss the process for accepting raw material.

This program will cover the remaining regulations excluding the QSR which was covered in Part 1. This webinar is especially helpful for new startup companies that are entering the medical device field for the first time.

Emphasis is placed on conducting effective process auditing through an internal audit program within a company’s quality management system. This webinar is intended to review the requirements for determining if a company has its processes under control, with reviews of the requirements and description of the methods to determine which processes are expected to be audited.

How do you create and blend the Risk Management File findings into your annual audit plan? How is it established, maintained, formally updated, and documented? Structured, defined and scheduled internal CGMP compliance audits are a specific requirement of US FDA 21 CFR 820 and ISO 13485 (devices), implied in 21 CFR 210, 211 (pharma)

This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device as well as track post market risks. Participants in this webinar will learn about techniques that will be useful in analysis of post market human factors design problems and in preventing these problems through pro-active use of post-market surveillance techniques and customer support data.

This webinar will provide valuable assistance to all device manufacturers who wish to have a better understanding of the requirements of ISO 13485. This webinar reviews the requirements of ISO 13485 in a straightforward manner, and includes suggestions for development of a compliant system.

This program will introduce the Quality System Regulation which defines the responsibilities for those who design, manufacture and distribute medical devices. This webinar is especially helpful for new startup companies that are entering the medical device field for the first time.

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.

Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report. The US FDA is increasingly stating that many regulated activities should be "risk-based". Major resource-consuming activities such as product and process / equipment / facility, and software validation, CAPA investigations, vendor audits can all be tailored to a risk based approach.

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.