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

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.

This Quality compliance training will helps in methodologies of Six Sigma and CAPA converging and how to recognize which methodology is best to use for a problem.

This FDA compliance training offers pragmatic approach to dealing with FDA mandated quality systems. The approach offered emphasizes function over form. Anyone subject to 21 CFR Parts 210, 211 and 820 will benefit from this seminar.

This Radiation dose training is the second of three presentations on the methodologies for the determination of the minimum sterilization dose.

This Change Control training will helps in change control implementation and management to ensure that documentation reviewed years later correctly reflects how product was designed, produced, tested, and released years earlier.

This Risk Analysis training guide you through the methodologies of and distinctions between Hazard Analyses, dFMEAs, and pFMEAs and step beyond performing Risk Analyses and documenting mitigations to the practical and proactive application. Did you know that you can use your existing Risk Analyses to help you do more than manage risk? Risk Analyses can be used to prioritize and streamline Design Input, Design Output, Design V&V, and both Pre-Production.

This HIPPA compliance training will give Practical tips on how to perform compliance audit in a manner that will protect the organization from legal challenge while also furthering security protections for patient-identifiable data.

This Product Safety training will guide you on how metrics can be used to analyze and improve the process for product safety. To meet regulatory requirements and to protect public health, pharmaceutical and biotech companies must collect, review, report, and assess product safety information to the highest standards.

This FDA compliance training will guide attendees through the entire process from establishing trainings, through developing and implementing training plans to FDA compliant documentation of effectiveness.

The steps for conducting Method 1 and identifying typical issues that might arise when conducting the test method. This presentation is the first of three presentations on the methodologies for the determiniation of the minimum sterilization dose.

This Risk Analysis training will be helped to see how to develop a compliant Hazard Analysis/Risk Management File and Report, as outlined in ISO 14971:2001, a standard recognized by the FDA and rapidly being adopted by industry.

This SOX compliance training will provide a uniquely effective road map to documenting and assessing risks at Pharma/Bio/Life Science companies.

This OOS (out of specification) training will guide you through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations.

This regulatory compliance training will help in frame working and Leveraging best-practices in the way of the business in a cost effective manner. Organizations face complex and rapidly evolving regulatory requirements, which have to be met within an equally fast-changing information threat environment.

This Computer System Validation training will guide you through Master Planning process.