Compliance Training Webinars for Regulated Industries

In this Auditing IT training learn how to assess an IT initiative’s implementation “preparedness” and how to reduce your IT risk.

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.

Many small or virtual companies make one of two common mistakes: their Quality Management System (QMS) is either too cumbersome for their operation or they don’t have a quality management system at all Quality management issues facing small, startup or "virtual" companies and identifying all required quality management system elements.

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.

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.

This Radiation Sterilization training will review all the changes included in the new standard and how they will affect the device manufacturer.

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 SAS 70 training will provide a Process of SAS 70 Audit, frequency & formatting of documenting controls in COSO and COBIT and SAS 70 Report types and impact of Sarbanes-Oxley to create the demand for SAS 70 audits.

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 Product safety training examines how product safety can fit into a stage gate new product development process, and provides recommendations and examples on how to make product safety become an integral part of the new product development process