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

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".

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.

This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.

This Medical device training will explain the regulatory requirements including cleaning and sterilization methods & validations.

This presentation is the third of three presentations on the methodologies for the determiniation of the minimum sterilization dose.

In this Medical device training will provide an explanation of what a New Approach Directive is and what they all have in common from a compliance perspective. The placing of a CE mark on a medical device implies compliance with all European "New Approach" directives that apply and typically three or four directives will have to be considered.

This presentation will provide and insiders view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches In 2002, FDA announced a significant new initiative, Current Good Manufacturing Practices (cGMPs) for the 21st Century intended to modernize FDA’s regulation of pharmaceutical quality and established a new regulatory framework for manufacturing.

In this Biopharmaceuticals training learn how can this guidance be applied given the rapid pace of development, the difficulty of defining the process and the product early in development, and the ever-changing regulatory environment. New draft guidance from the ICH indicates that process development should include risk assessment, definition of ’design space’, and suitable designed experiments to define a safe operating range.

In this design Input training we will define design input, review robust requirements development, assess the impact of user needs vs. patient needs and discuss options for timing your design reviews.

This Validation training describes logical approaches to efficiently develop assays that will deliver quality data. The main body of the talk reviews current industry guidelines with a goal to preparing a scientific validation protocol and method. The seminar also analyzes critical validation parameters, describes common technical pitfalls between various technologies and suggests solutions

In this Quality Risk Management training develop and implement a policy for a Quality Risk Management Program and determine how to select the direct-impact systems and processes to apply your policy - formal QRM.

This Internal Audit Training will discuss the tools and techniques to design, implement and maintain the internal audit system to prevent audit system problems. The internal audit system must be successful for the business to be successful.

Essential elements of tort law, product liability and defensive strategies to protect your company In this Training, essential elements of tort law, product liability and defensive strategies to protect your company will be outlined in detail.

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.

Modifications in the EU law governing authorization of pharmaceutical products - The Cyprus clause, the new position of the innovative products and changes for the generic industry. The EU law governing authorization of pharmaceutical products has been substantially modified. The periods of market and data protection for innovative products have been clarified.

This CAPA session will discuss these common pitfalls and share best practices, strategies and techniques on how to deal with CAPA system in relation to Warning Letters and 483 citations. In 2005 greater than 50% of FDA Warning Letters and 483 citations were CAPA related.

In this CAPA training learn how to utilizing multiple data sources to detect actual and potential nonconformities.

Key areas that the FDA is likely to cover and what FDA’s expectations are This presentation will focus on those areas that the FDA is likely to cover and what FDA’s expectations are.