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

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 New draft guidance from the ICH indicates that process development should include risk assessment, definition of ’design space’, and suitable designed experiments to define a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.

This will review how EO sterilizes, basic factors affecting sterilization, calculating the D value, Biological Indicators, the processing steps, EO residuals, and product release in a practical manner. Many companies are using EO to achieve product sterility. Whether EO sterilization is performed in-house or with a contract sterilizer the product manufacturer must be informed as to how the process works.

This Hazard Analysis training will show you how to make the Hazard Analysis process work for you, what value it has for the entire life cycle of your product and how to use the process to help focus your design and process development efforts.

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.

In this Sterilization training will review these requirements and practices for gamma and electron beam irradiation in a practical manner so the product manufacturer can better understand the application of the ANSI/AAMI/ISO 11137 and AAMI TIR 27.

This Supplier Quality Management training is targeted at intermediate-level quality managers who are looking to bring best practices discipline into their supplier quality management and environment. Supplier Quality Management is a critical business process for manufacturers who source components and parts from suppliers, whether the suppliers are just across the street or a continent away.

This HPLC theory (high performance liquid chromatography) training will cover the beginnings of HPLC through method validation and method development. Attention will be paid to understanding the thought process behind HPLC theory methods in the laboratory.