FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

The European Union has stated their requirements in Annex 13, while FDA has recently issued a controversial new phase 1 guidance Join us for a discussion of actual requirements, and both historic and current guidance document recommendations

This FDA Inspection will discuss FDA inspection readiness techniques and how to prepare your organization for a facility inspection.

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 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.

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.

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.

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.

This cGMP Documentation training will provide value to regulated companies required to follow strict documentation standards, whether GLP, GCP, or GMP.

In this Medical device training will show you how to make the DFMEA process work for you. How to use the process to help focus your testing matrix to target the most critical aspects of the product's design and function.

How a common COBIT-based IT control solution can satisfy multiple regulatory and business requirements. This seminar will show you that a common IT control solution should be available to satisfy multiple regulatory and business requirements.

This DOE (Design of experiments) training focuses on DOE strategies. It is not focused on statistical methods, analysis of variance, and other techniques, but rather the overall approach for successful DOEs.

This Validation training will guide attendees through the entire process from defining specifications, through developing and implementing validation experiments to FDA compliant documentation.

This Clinical Trial training will helps in implementing Metrics that can be used as clinical trial performance improvement indicators.