Process Validation Toolkit

A collection of IVT's knowledge of process validation, this toolkit is composed of two years of Validation Week presentations, the Process Validation Lifecycle e-Book Series, a recorded validation seminar, a sampling instruction and a process validation whitepaper, and two validation master plans. These materials will guide process validation practitioners in effectively implementing a lifecycle approach to process validation and, thereby, achieving compliance with global regulatory agencies.




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Products in this Toolkit

| Validation Master Plan | December 17, 2012 - 4:31 am EST

Site Validation Master Plan

The Site Validation Master Plan will help you lay out the validation program for your company. It incorporates the validation activities related to your company's manufacturing facility for the manufacturing, storage and distribution of your products.Download the Site Validation Master Plan Download the accompanying presentation "Developing a Validation Master Plan (VMP) that Survives the Life Cycle," presented at IVT's Annual Validation Week EU, Amsterdam, Netherlands, March 2011.

| Regulatory & Industry Guidance | Product Code: RIGQ011 | January 6, 2013 - 7:02 pm EST

Process Validation

The fundamental principle of process validation is to ensure products are manufactured in accordance with the intended use, quality, safety, and efficacy are designed or built into the product, quality cannot be tested or inspected into the final product, and each step in a manufacturing process is controlled to assure that the finished product meets all design characteristics and quality attributed including specifications. This guidance will provide a pathway for navigating the major regulatory process qualification requirements and discuss current regulatory submission feedback to meet compliance...

| Special Edition | Product Code: SPEQ0017 | January 13, 2013 - 2:21 pm EST

Process Qualification

This is Part II to IVT's three-part special edition series on process validation. This special edition is a collection of articles and papers from the Journal of Validation Technology and the Journal of GXP Compliance and focuses on equipment qualification, process qualification documentation, quality risk management, and compliant sampling. Introduction to FDA Stage 2: Process Qualification The testing performed in this process validation stage confirms that the process design is capable of manufacturing drug product at commercial scale in accordance with the process...

| Special Edition | Product Code: SPEQ0016 | January 13, 2013 - 3:04 pm EST

Process Design

This special edition is a collection of articles and papers from the Journal of Validation Technology and the Journal of GXP Compliance that expound such topics as knowledge building with probability distributions, a step-by-step process for design-of-experiment, quality-by-design, and hypothesis testing, this e-Book will firmly establish the scientific foundations of a manufacturing process.Table of Contents

| Special Edition | Product Code: SPEQ0018 | January 13, 2013 - 4:11 pm EST

Continuing Process Verification

This is Part III of IVT's special edition series on process validation. A collection of papers and articles from the Journal of Validation Technology and the Journal of GXP Compliance, this e-Book covers controlling and reducing variation, revalidation, managing analytical error, and the process nonconformity concept Introduction to FDA Stage 3: Continuing Process Verification This stage may be simply described as “maintaining validation” or “maintaining the validated state.” Maintenance activities of Stage 3 should be commensurate with the risk identified for the...

| White Paper | Product Code: WHTQ0001 | January 16, 2013 - 4:46 pm EST

A Pocket Guide to cGMP Sampling

Sampling is a key current good manufacturing practice (cGMP) activity that impacts nearly every activity of manufacturing pharmaceutical products. Sampling is used during the assessment of raw materials, labeling, and components prior to release, validation of equipment, processes, systems, and products; products during production; finished products prior to release; products during stability studies; and data before, during, and after productionThe appropriate knowledge and application of cGMP requirements for sampling is critical to the development of a scientifically sound quality...

| Product Code: IVTQ1234 | October 31, 2016 - 3:00 am EDT

Validation Essentials

This webinar will discuss the fundamentals of effective and US Food and Drug Administration-compliant process validation. The background to FDA's Process Validation: General Principles and Practices will be discussed, and the requirements will be analyzed. Attendees will learn how to apply and implement this guidance into cleaning and method validation, equipment and facility qualification, and quality systems.

| Conference Compendium | Product Code: IVTO6083 | November 15, 2016 - 3:00 am EST

22nd Annual Validation Week

22st Annual Validation Week Highlights include:Over 40 Sessions All Dedicated to Validation and GMP Practice  Explore the practical and advanced presentations on validation execution which Include both “nuts-and-bolts” and “advanced” materials.Presentations by the“Crème de la Crème” of Validation Experts in the FDA Regulated IndustryThe speaking faculty for the 22nd Annual Val Week included the most experienced validation and compliance professionals from regulatory agencies, pharmaceutical, biotech and medical device industries, and selected technology and software providers....

Conference Compendium | Product Code: IVTQ7083 | October 27, 2017 - 12:35 pm EDT

23rd Annual Validation Week Compendia

"I gained the knowledge and literature necessary to bring back to my workplace to convince all departments that validation is a lifecycle and team effort." - Process Development Associate, AgillentWhen you download this compendia, you have access to the hundreds of slides from the best and brightest in the industry, right at your fingertips!Migration to Pharma 4.0 — Navigate Emerging Quality Compliance Challenges and Preview the Validation Road AheadChinmoy Roy, Genentech Inc.Explore the Parallels between Process Validation and Design VerificationRoberta Goode, MSBE, CQE, Goode...

| Master Validation Plans | Product Code: IVTQ2018 | November 17, 2017 - 1:52 pm EST

Master Validation Plan SOP and Approval Template

The attached comprises three documents providing fundamental aspects of the VMP.  These include an overview description of VMP and applications implemented by various organizations, an actual VMP form that would be approved by relevant groups in the organization, and an SOP providing directions to create the VMP.Validation Master Plan (VMP), Part 1.  Differences in Terminology, Content, and Applications provides basic considerations associated with the topic of the Validation Master Plan (VMP).  This discussion identifies four different VMP types commonly used in pharma and related...

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