Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

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 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.

This Quality compliance training provides an understanding of the concepts, intent and the application of the process approach to the ISO standards. This webinar provides an understanding of the concepts, intent and the application of the "process approach" to the ISO 9000 family of Quality Management System standards.

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.

In this Cleaning Validation training will discuss strategies that assure that cleaning validation is started at the optimal time of the product development cycle, current trends, and some of the challenges that must be addressed.

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.

In this ISO 9001:2000 Training Understand the ISO 9001:2000 standard requirements for 1st, 2nd and 3rd part audits.

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

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.

Get a detailed understanding of how to perform risk assessment as part of the 10-step risk based approach to CSV.