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

This training program will dispel mistaken paradigms regarding the risk based approach to water system lifecycle. It will detail how to eliminate variability – the cause of most deviations. Attendees will learn how to capitalize on the advantages of online analytical instrumentation (chemical and microbiological rapid methods).

This course will detail various sterilization methods and various approaches for the validation of a sterilization process.

This training program will discuss each of the critical aspects of freeze drying and the related effects of variables. The course will also discuss sublimation rate variability, heat transfer, loss of protein activity, and freezing effects on primary drying.

This webinar will teach attendees how to prepare for, manage, and follow up on FDA inspections. It will discuss common pitfalls to avoid during an inspection.

This CAPA program provides the framework for avoiding an FDA warning letter and increasing quality standards for your organization while keeping production levels high.

This FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls.

This course will instruct attendees on establishing an approach to process control within each unit of operation to generate overall process control needed for validation. The webinar instructor, an FDA expert, will enumerate the importance of variation in enhancing a validated means of operation and the parameters that can cause variability. The Randomized Block statistical model will also be analyzed for effective validation.

This webinar will explain how to incorporate a quality system into the validation process to reduce cost and ensure compliance. It will cover the analysis, design and initiation phases, including full implementation of the incorporation.

This training on FDA software validation related warning letters will discuss what to do to avoid additional software related compliance issues along with the response steps where the citations that directly or indirectly include automated system.

This FDA software validation training will discuss how to approach strategic software validation planning so as to satisfy FDA by complying to new enforcement initiatives by FDA.

This 90-minute webinar will provide a clear understanding of the concepts of computerized system validation, and describe the steps to be taken by a project team for a well-controlled and successful computerized system validation.

This Software Verification and Validation training will help you understand and recognize the most common software V&V failings and their fixes. You will learn how to develop and use a repeatable software V&V template for all software validation projects.

This Water system validation training will guide you on how validation should be customized to your particular water system design and maintenance practices, what operational elements should be included in the microbial testing during validation and which ones need not be. Understanding the purpose of water system validation will allow you to see the fallacies of many standard protocol templates bred by tradition and do only what is appropriate for YOUR water system.

This FDA validation training will describe methods for planning and executing spreadsheet validations that satisfy FDA requirements.

This training will provide a practical methodology for creating and applying Risk-Based Equipment Validation. It will show an example of how this process may be integrated into a facility Master Validation Plan.

This 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records.

This webinar on validating legacy computer systems will give a good understanding of FDA and EU regulatory requirements for validation (retrospective validation) and provide tools for effective implementation.

This 21CFR Part 11 training will clarify the relationship between predicate rules and 21 CFR part 11 compliance, allowing companies to satisfy FDA with a minimum of effort.

This 3-hr virtual seminar on the Electronic Common Technical Document will help you understand the background, technical aspects, document structure, and use of the electronic Common Technical Document.

This Spreadsheet validation training will cover the use of spreadsheets to report data from the inception of the spreadsheet (user requirement specification), through the development process, validation, and use.