FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.

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.

The FDA and ISO requirements for computer system validation and key methods for meeting those requirements. Many regulated companies are still using unvalidated computer systems. Computer system validation is required by the FDA as well as ISO 13485: 2003. Medical device companies must transition to the 2003 version of 13485:2003.

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.

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 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.

This GMP (Good Manufacturing Practice) training will discuss strategies to ensure that your resources are deployed to maximize risk reduction, sustain GMP compliance, and respond to exceptions appropriately. Raw materials used in GMP production must be qualified, sourced appropriately, and tested before release into use. Regulations regarding sampling and testing vary globally, creating business and compliance challenges.

This Computer system training will discuss strategies and provide tools for FDA compliance when managing change and version control of planned and unplanned changes.

This FDA compliance training will explain how to measure and reduce the FDA recordkeeping burden.

Validation and use of Microsoft Excel Spreadsheets, Good documentation practices, Using Styles in Microsoft Word, Reducing the cost of creating documents. This pack of four training courses provides 4 hours of traning on validation and use of Microsoft Excel Spreadsheets, good documentation practices, using Styles in Microsoft Word, and reducing the cost of creating documents in FDA Regulated Industries.

Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.

This webinar addresses the Computer Software Assurance guidance related to 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It details the evolution of industry practices that increase productivity and ensure compliance. Learn the latest validation models and fill-in-the-blank templates.

The following is a pack of 4 best-selling training CDs for sales, marketing & regulatory professionals in the Medical Device industry. These courses provide solutions for all critical challenges & questions faced by you and your team pertaining to regulations/compliance, best practices, etc.

This 90-minute webinar on laboratory OOS investigations will review the regulatory requirements for an OOS Investigation. You will learn common regulatory pitfalls and how to structure an Investigation report that satisfactorily documents the investigation.