FDA Validation Requirements Regulatory Compliance Training - Live Webinars, Recordings & CDs

In this presentation, we will look at these documents from the investigator’s point of view, reviewing the FDA training manual and actual FDA warning letters and responses. This will reveal what the investigator is trained to look for and what types of problems are actually being discovered in the field offices.

This session describes how to use the GAMP® standard to determine what has to be validated and explains how to create documentation that will meet regulatory requirements worldwide.

This presentation explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.

While simple to describe many companies fall into the trap of territoriality, and confusion of roles and responsibilities. This webinar will walk through the elements of a process validation program for biological products with an emphasis on the involvement of all functions especially process development.

Understand why the VMP is a project management tool and why it’s a living, breathing document. This webinar will provide valuable assistance and guidance to all life sciences manufacturers that are preparing to use or are currently using validation master plans to bullet-proof their validation programs.

Companies are unsure on what exactly to qualify or re-qualify test and document. The main reason is that unlike for analytical methods there are no clear standards for equipment qualification. The USP has developed a new standard for analytical instrument qualification (AIQ). It will be official by August 1, 2008.

The webinar will address each audit item and train the participants how to determine the compliance status. We will use common examples of non-compliance observations from actual audits and suggest remediation plans that are compliant, efficient and economical.

This will teach part 1 of defining and refining objectives and selecting the best of alternative courses of action.

This webinar will provide valuable assistance to all regulated companies that need to validate their systems The series will deal with Operational Qualification (OQ), Performance Qualification (PQ), and maintaining a state of validation using statistical methods associated with Six Sigma

The mutually exclusive roles for Quality Assurance and Quality Control in validation will also be discussed. Across 20+ years of global regulations and guidance related to computer systems, there are four common themes that provide the foundation for auditable validation efforts.

This Part 11 - Electronic Records webinar will provide an insider’s view FDA’s current thinking regarding the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).

This FDA compliance training will review the FDA Software Standard "General Principles of Software Validation". The process that FDA investigators use relative to software failure investigations will also be discussed.

This Validation training will provide guidance in overcoming inherent variability in bioassays. Performing good optimization studies will lead to a well-defined method for future qualification and validation of the assay

This Validation training will provide valuable assistance to all regulated companies that need to validate their systems. Project management is the application of knowledge, skills, tools, and techniques to manage project activities to meet project requirements

In this Risk Based Validation training we will go through various scenarios and recommend actions for validation and other controls.

This Validation training will provide valuable assistance to all regulated companies that need to validate their systems and will introduce measurement validation using Gauge R&R. Will introduce measurement validation using Gauge R&R. R&R standing for Repeatability and Reproducibility

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.

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

Understand the 10-step risk based approach to validation, explore methods to decrease resource requirements, and learn how to make documentation more manageable and understandable.

This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.