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

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.

Best practices in Quality Management System and management controls needed to meet US FDA and ISO 13485 requirements This pack of two training courses provides 2 hours of training on basic requirements and best practices of quality management system for non-Regulatory and Quality Assurance experts in the medical devices industry as well as principles and practices needed to effectively develop and implement the Management Controls necessary to ensure an effective Quality Management System (QMS) and to comply with the requirements of the FDA QS Regulation

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.

This presentation gets to the real intent of the HIPAA training requirements and gives practical advice both for regulatory compliance and for boosting privacy and security program effectiveness. Many healthcare organizations subject to HIPAA federal regulations fall short in their privacy and security training programs today. But people are the weakest link when it comes to good security. Security professionals and NIST Special Publications agree that effective and repeated training is necessary for employees and other staff to consistently follow good privacy and security practices and behavior.

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.