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

This FDA compliance training will review the FDA Software Standard "General Principles of Software Validation". The process that FDA investigators use relative to software failure investigations will also be discussed.

This statistical process control training will provide an overview of statistical process control (SPC) describe various types of control charts and how they can be used for trend analysis, defect reduction, product capability assessment. Quality, safety and efficacy must be designed into a product. Quality cannot be inspected or tested in the finished product.

This FMEA (Failure mode and effects analysis) training will cover the Joint Commission requirements for conducting a proactive risk assessment using the FMEA methodology.

This 510(k) Clearances training/webinar will provide valuable assistance to all regulated companies that need to validate their systems.

This presentation will review methods for finding predicates, using guidance documents and interacting with the agency. Participants will learn about the different types of 510(k) submissions and the benefits and drawback of using the 3rd party.

This Validation training will provide guidance in overcoming inherent variability in bioassays. Performing good optimization studies will lead to a well-defined method for future qualification and validation of the assay

This Management control training will provide the principles and practices needed to effectively develop and implement the Management Controls to ensure an effective Quality Management System and to comply with the FDA QS Regulation.

This Complaint Handling training will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback.

This training will identify and review the key planning documents, including team assignments, management and conduct of the project, project phases, and regulatory requirements and scheduling.

This Quality training will help you look holistically at your quality systems and embrace a continuous improvement approach that will drive quantifiable business benefits. A quick review of your log of corrective and preventive actions can be quite revealing. Many executives have found that their past improvement initiatives only addressed problem areas regarding individual products.

This program is designed for the medical device, IVD, and combination product industries This webinar will provide the core principles and practices needed to implement an effective and efficient CAPA process

In this Medical device training will provide valuable assistance to regulated companies on how to drive regulatory compliance for IT based medical devices.

This Medical device training will talk about recent developments in the European Commission’s approach towards the parallel distribution of medicines. In the past the European Commission has taken a strong stance against restrictions imposed by pharmaceutical companies on wholesalers and distributors of medicines, preventing them from parallel importing the contract products within the European Union ("EU").

In this Risk management training we will review the concept of Risk Management, its various elements, what is required, and its benefits. How are you meeting the FDA and ISO risk management requirements? Hazard Analysis? FMECA? dFMEA/pFMEA? The concept of Risk Management and the difference between risk analysis, evaluation, assessment, and management.

The principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485. This medical Device training will provide the principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485.

In this Medical device training understand the expectations of FDA and the EU in applying risk analysis to medical devices. Risk Management is required by ISO 13485 and risk analysis by the FDA’s Quality System Regulations (QSR) and by of the EU medical device regulations. Using practical examples, this course look at the regulatory and reporting requirements of EN ISO 14971, "Medical devices - application of risk management to medical devices".

This Pharmaceutical training examines the system its benefits and its drawbacks and how effective is the system established between the EMEA and the FDA. The authorization of medical products by the FDA is not recognized in the EU. Neither is authorization by the EMEA Recognized by the FDA.

Key insights to the background of the revision for medical device manufacturers with products in Europe. The Medical Devices Directive 93/42/EEC (MDD) is the key European Directive for regulatory compliance and placing of a CE mark on a medical device.

This Internal audit training will guide on how to set up an ISO 14971 audit program with specific auditor guidelines.