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

This 510(k) Training covers the content requirements of a traditional 510(k) application and covers in detail the recommended 20 sections. This 510(k) Training deals only with those medical devices that require a 510(k) application. All Manufacturers introducing Class II medical devices to the US market must submit a FDA 510(k). It is also required for manufacturers that are changing the intended use of the medical device, or changing the technology of a cleared device such a way that it may significantly affect its safety or effectiveness.

This webinar will provide valuable assistance and guidance to medical device companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC.

This webinar describes the importance of and the key elements in a test method validation, including an understanding of its adequacy, range of detection, accuracy, the precision of measurements, and ultimately its robustness and reliability.

This Medical Device training will describe the information needed to write such protocols, and the basic contents of those protocols. This webinar will provide valuable assistance to all regulated companies that need to validate their manufacturing processes.

This CAPA training provides a process to overcome challenges for Documentation and Conducting CAPA Investigations and integrates FDA requirements and guidelines. "Failure to employ effective CAPA systems can lead to FDA Warning Letters and worse. Accurate documentation is a must – but capturing information from a diverse workforce can be very difficult. Do you have what it takes to meet these challenges?".

Fact: The FDA has noted that 76% of all Warning Letters have CAPA-related issues. This is a significantly large percentage – the results of companies doing a bad job of identifying corrective and preventive actions as well as not validating plan effectiveness.

This session will highlight typical manufacturer pitfalls in designing user studies and usability tests as well as common mistakes and omissions regarding use error in PMA and 510K submissions. This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device.

This training course will concentrate on how to prepare for the audit, from language and culture to technical requirements and auditor expectations. Due to the 2005 revisions in the Japanese Pharmaceutical Affairs Law (PAL), the PMDA - Pharmaceuticals and Medical Devices Agency - is beginning to step up its scheduling of on-site audits of foreign medical device manufacturers.

This Sampling training will answer all your questions about acceptance sampling for defectives.

The process is critical for device manufacturers to effectively evaluate and select suppliers and subsequently implement agreements ensuring consistent material quality and/or services provided. This webinar will provide a valuable and informative overview and guidance to manufacturers, especially medical device companies that are preparing to establish or have established supplier/vendor management qualification programs.

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.

In this course, we will introduce you to a new method of managing your CAPA system, The Gateway: A Risk-based Filter. This webinar is geared toward professionals in the QA/AC and CAPA discipline and is appropriate for individuals who are regularly called upon to resolve problems, or whose input would aid in preventing problems.

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

This webinar will provide valuable assistance to all regulated companies that need to validate their systems In this session we will introduce basic control charting and statistical methods to determine if a process is capable of consistently producing product within specifications and how to make it capable if it is not

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.

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.

Learn the appropriate and expected regulatory strategies and guidelines for your IDE. This webinar will provide valuable assistance and guidance to medical device firms that are currently preparing or will prepare for IDE submissions.