Product Toolkits

GMP Compliance Toolkit

This product toolkit will guarantee regulatory compliance with FDA and global regulatory agencies. Consisting of two special editions, two pre-recorded webinars, and a specialized IVT conference compendium, this product collection covers GMP Training, investigations and inspections, documentation, quality agreements, HACCP, and utilizing statistics.

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| Video | VIDQ0007 | Oct 16, 2012 4:28 am PDT

Best Practices for Creating Quality Agreements

This webinar discusses the basic principles of a quality agreement, as well as the responsibilites, best practices, and FDA suggestions. Download the presentation here.
| Video | VIDQ0009 | Nov 9, 2012 7:12 am PST

Hazard Analysis and Critical Control Points (HACCP)

This pre-recorded webinar discusses the essential aspects and principles of Hazard Analysis and Critical Control Points (HACCP) including critical limits, monitoring, corrective action, and decision trees. Download the presentation here.
| Special Edition | SPEQ0014 | Jan 8, 2013 2:50 pm PST

Roadmap to GMP Compliance Part I

Implementing the Tools of Process Quality — A Policy Statement Lynn TorbeckData Culture Lynn TorbeckAn Example of Absence of a Data Culture Lynn TorbeckUpsizing Compliance in a Downsizing Environment: Strategies for Ensuring GXP Compliance in the Face of Cost Reductions Eldon Henson
| Special Edition | SPEQ0015 | Jan 18, 2013 12:28 pm PST

Roadmap to GMP Compliance Part II

Preparation, Preparation, and More Preparation Ballard Graham, Richard Poska, Robert Ertmann, and Paul L. PlutaIt’s All About Trust David MarkovitzImproved Utilization of Self-Inspection Programs within the GMP Environment–A Quality Risk Management Approach Barbara JeroncicGXP Compliance–Start with the Basics David MarkovitzFirst Impressions—The Plant Tour Paul L. PlutaFDA 483 Responses—Compliance Considerations Richard Poska and Ballard Graham
| Conference Compendium | IVTQ6108 | Nov 15, 2016 12:00 am PST

Validation and GMP Week Puerto Rico 2016

Professionals Working in the GMP and Validation Environments met to:Understand FDA’s Quality Metrics Draft Guidance Learn how to use statistics in validationMaintain a robust cleaning and computer/software programsDevelop a Validation Master Plan (VMP) in critical environmentsConduct a gap analysis of your validation and GMP programs

Analytical Method Validation Toolkit

This toolkit highlights the most comprehensive information on analytical method validation and method development. With four robust volumes of thought leadership from the Journal of Validation Technology and the Journal of GXP Compliance, and thousands of slides from IVT's Laboratory Week conferences, this educational toolkit will ensure you keep abreast of ongoing method strategies and global regulatory trends.

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| | SPEQ0002 | Jan 17, 2013 1:32 pm PST

Analytical Method Validation

Validating Immunoassays Using the Fluorescence Polarization Assay for the Diagnosis of Brucellosis David Gall and Klaus NielsenStep-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry Ghulam A. ShabirGood Analytical Method Validation Practice: Setting Up for Compliance and Efficiency: Part I Stephan O. Krause, Ph.D.Good Analytical Method Validation Practice: Deriving Acceptance Criteria for the AMV Protocol: Part II Stephan O. Krause, Ph.D. 
| | SPEQ0003 | Jan 17, 2013 1:47 pm PST

Analytical Method Validation Volume II

Biological Method Validation A Practical Approach Cindy GreenDefining a Master Plan for the Validation of Analytical Methods Paul A. Winslow, Ph.D. and Richard F. Meyer, Ph.D.FDA and Industry Address Analytical Validation Issues for the Pharmaceutical Industry Jerry Lanese, Ph.D.Guidance for Industry Bioanalytical Methods Validation for Human Studies US Food and Drug Adminstration
| | SPEQ0021 | Oct 7, 2013 12:02 pm PDT

Analytical Method Validation Volume III

Method Validation Studies: How GLP Interacts with Guidance Documents Steven S. Kuwahara, Ph.D.Reduction of Analytical Method Variability in an R&D Laboratory: A Case Study Briank K. Nunnally, Andre Johnson, and Raymond KaiseMethod Validation (for Medical Devices) Laure LarkinUse of Monte Carlo Simulation to Address CMC Issues Harry Yang, Ph.D.Validation of Dissolution Methods Gregory P. Martin and Vivian GrayUSP <1010> Analytical Data-Interpretaion and Treatment Appendix E: Comparison of Methods Lynn TorbeckAddressing Compliance Concerns During Dissolution Method Development, Validation,...
| SPEQ1705 | Jun 2, 2017 7:30 am PDT

Analytical Method Validation Vol. IV

Table of ContentsFDA SIgnals a New Approach for Analytical Method Validation by Tim SandleAligning with the New Guidance: FDA Analytical Procedures and Method Validation by Ivan SotoLifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Validation by a USP Validation and Verification Expert Panel The Use of the Analytical Target Profile in the Lifecycle of an Analytical Procedure: with an Example for an HPLC Procedure by Jane Weitzel, Robert A. Forbes, & Ronald D. SneeStatistical Analytical in Analytical Method Validation...
Conference Compendium | IVTQ7097 | Jul 6, 2017 10:48 am PDT

Stability Testing Europe

-User Requirements and Implementations of a Risk-Based, Compliant Stability Management System that is Aligned with FDA's New Data Integrity Draft Guidance- Novel Approaches Involving Lean Stability Processes and Outsourcing- Risk-Based Processes to Enhance Stability Programmes- OOT and OOS in Stability Studies- Moisture and its Control in Stability- Theory and Practical Design of Forced Degradation StudiesPlus! Benefit from materials from 6 breakout sessions. Download the compendia.
Conference Compendium | IVTQ7081 | Dec 14, 2017 8:09 am PST

Analytical Procedures & Methods Validation 2017

Our compendia features new content, tailored directly from industry feedback, on the most pressing needs and successful solutions for method validation today. Featured conference highlights include:Practical Applications for Critical Method Validation ProceduresIndustry Pulse on Emerging Regulatory Trends and Waring Letters – FDA, MHRA, USP and BeyondValidation and Transfer of Analytical Methods for Biologics to Enable Commercial Launch
Conference Compendium | IVTQ8097 | Jul 12, 2018 8:35 am PDT

Laboratory Week Europe

Analytical Methods for Biological Products by Lokesh Bhattacharyya, U.S. Food and Drug Administration (FDA)EU GMP Guide - Recent Challenges for the Quality Control Laboratory by Michael Zwitkovits, Austrian Federal Office for Safety in Health Care (AGES)Lessons Learned from FDA Warning Letters to Strengthen Your Programme and Mitigate Risk by Karen Ginsbury, PCI Pharma Ltd.Click here to download the agenda for Stability Testing. Click here to download the agenda for Analytical Procedures & Methods Validation.Download the conference compendium.&nb

Computer and Software Validation Toolkit

This collection of IVT Computer and Software Validation Products will guarantee compliance in the ever-changing and evolving CSV environment. With two ebooks, five conference compendiums, and two conference presentations, this toolkit offers strategies for electronic records and signatures management, the emergence of cloud computing and virtualized environments, international regulations and guidances, risk management and change control integration, automated testing tools, building software, data integrit

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| Special Edition | SPEQ0005 | Jan 11, 2013 7:54 am PST

Computer and Software Validation

Computer System Design Robert Smith System Design and Control Robert H. SmithThe Nine Most Common Computer Validation Problems: Identify Frequent Deficiencies to Accelerate Your Validation Projects Frank HoustonAccurately Identifying Your Requirements—Will Any Computer System be Right for You? Janis V. Olson
| Video | VIDQ0015 | Jan 23, 2013 12:38 pm PST

Business Owners, Users or Stakeholders…Who is Accountable for Data Quality, Integrity and Confidentiality?

Download the presentation, "Business Owners, Users  or Stakeholders…Who is Accountable for Data Quality, Integrity and  Confidentiality?", presented at IVT's Qualifying and Validating Cloud and Virtualized IT Infrastructures, Philadelphia, PA, August 2012.
| Video | VIDQ0012 | Jan 24, 2013 1:35 pm PST

SOPs for Managing Application Service Providers

Download the presentation here.
| Special Edition | SPEQ0022 | Nov 6, 2013 2:22 pm PST

Computer and Software Validation Volume II

Software Validation: Can an FDA-Regulated Company Use Automated Testing Tools? Janis OlsonConsiderations for Validation of Manufacturing Execution Systems Chris Wubbolt and John PattersonLifecycle Considerations for Device Software John E. LincolnStorm Clouds? Cloud Computing in a Regulated Environment Robert H. SmithBuilding High Quality Software Robert H. SmithComputer System Compliance and Quality Planning Benard T. O'ConnorValidation of Software "In-Product" or "As-Product" John E. LincolnRequirement Management Orlando LopezIntegrating Risk Management into Computer System Validation Timothy...
| Conference Compendium | CONF0426 | Aug 3, 2016 8:41 am PDT

2016 Computer and Software Validation

Sessions include:Qualification of Cloud Infrastructures and Vendor On-Boarding Processes Securing and Validating Excel Spreadsheets Network Infrastructure Qualification Data Migration and Verification Validation of Mobile Devices and Software Applications Development of a Risk-based Impact AssessmentReducing Costs while Maximizing ProductivityIdentifying and Overcoming Data Integrity ChallengesCreation of a Global CSV Gap Analysis Program — Track, Report and RemediateImplementation of a Risk-based Approach to Audit Trailsand much more!Download compendium here
| Conference Compendium | IVTQ7005 | May 1, 2017 2:01 pm PDT

18th Annual Computer & Software Validation - 2017

On April 25-27 in San Diego, CA, computer and software validation experts convened to build robust, compliant,and agile CSV systems. There were 24 plenary and expanded sessions including: Manage changes to GxP computer systems and IT infrastructure Reduce costs in computer and software validation Implement a risk-based approach to electronic data integrity compliance Audit and monitor vendors for CSV compliance Qualification of cloud infrastructures Validation of GxP Spreadsheets Two in-conference workshops: Develop a Roadmap for Implementation of a Global CSV Program and Validation of...

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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| Validation Master Plan | Dec 17, 2012 1:31 am PST

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 | RIGQ011 | Jan 6, 2013 4:02 pm PST

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 | SPEQ0017 | Jan 13, 2013 11:21 am PST

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 | SPEQ0016 | Jan 13, 2013 12:04 pm PST

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 | SPEQ0018 | Jan 13, 2013 1:11 pm PST

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 | WHTQ0001 | Jan 16, 2013 1:46 pm PST

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...
| Video | IVTQ1234 | Oct 31, 2016 12:00 am PDT

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 | IVTO6083 | Nov 15, 2016 12:00 am PST

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 | IVTQ7083 | Oct 27, 2017 9:35 am PDT

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 Compliance InternationalFDA...
| Master Validation Plans | IVTQ2018 | Nov 17, 2017 10:52 am PST

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...

Analytical Method Validation Vol. I-IV - The Complete Collection

This four-volume, 265-page set from the Institute of Validation Technology offers detailed discussions on achieving compliant analytical method validation as well as specific case studies that demonstrate best practices. This is a downloadable PDF product — start applying its lessons immediately!

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| Special Edition | SPEQ0002 | Jan 17, 2013 1:32 pm PST

Analytical Method Validation

Validating Immunoassays Using the Fluorescence Polarization Assay for the Diagnosis of Brucellosis David Gall and Klaus NielsenStep-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry Ghulam A. ShabirGood Analytical Method Validation Practice: Setting Up for Compliance and Efficiency: Part I Stephan O. Krause, Ph.D.Good Analytical Method Validation Practice: Deriving Acceptance Criteria for the AMV Protocol: Part II Stephan O. Krause, Ph.D. 
| Special Edition | SPEQ0003 | Jan 17, 2013 1:47 pm PST

Analytical Method Validation Volume II

Biological Method Validation A Practical Approach Cindy GreenDefining a Master Plan for the Validation of Analytical Methods Paul A. Winslow, Ph.D. and Richard F. Meyer, Ph.D.FDA and Industry Address Analytical Validation Issues for the Pharmaceutical Industry Jerry Lanese, Ph.D.Guidance for Industry Bioanalytical Methods Validation for Human Studies US Food and Drug Adminstration
| Special Edition | SPEQ0021 | Oct 7, 2013 12:02 pm PDT

Analytical Method Validation Volume III

Method Validation Studies: How GLP Interacts with Guidance Documents Steven S. Kuwahara, Ph.D.Reduction of Analytical Method Variability in an R&D Laboratory: A Case Study Briank K. Nunnally, Andre Johnson, and Raymond KaiseMethod Validation (for Medical Devices) Laure LarkinUse of Monte Carlo Simulation to Address CMC Issues Harry Yang, Ph.D.Validation of Dissolution Methods Gregory P. Martin and Vivian GrayUSP <1010> Analytical Data-Interpretaion and Treatment Appendix E: Comparison of Methods Lynn TorbeckAddressing Compliance Concerns During Dissolution Method Development, Validation,...
Special Edition | SPEQ1705 | Jun 2, 2017 7:30 am PDT

Analytical Method Validation Vol. IV

Table of ContentsFDA SIgnals a New Approach for Analytical Method Validation by Tim SandleAligning with the New Guidance: FDA Analytical Procedures and Method Validation by Ivan SotoLifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Validation by a USP Validation and Verification Expert Panel The Use of the Analytical Target Profile in the Lifecycle of an Analytical Procedure: with an Example for an HPLC Procedure by Jane Weitzel, Robert A. Forbes, & Ronald D. SneeStatistical Analytical in Analytical Method Validation...

Cleaning Validation Toolkit

Cleaning remains the backbone of validation and scholarship, practices, and regulations continue to change, adapting to new technologies and markets. Gathered from the best and most recent cleaning articles from The Journal of Validation Technology and The Journal of GXP Compliance, IVT Network presents a compilation of their multi-volume books series.

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| Special Edition | SPEQ9999 | Apr 3, 2014 11:09 am PDT

Cleaning Validation Volume III

Table of ContentsEquipment Cleaning Validation: Microbial Control Issues Destin LeBlancCleaning Validation: Maximum Allowable Residue: Question and Answer William E. Hall, Ph.D.Development of Total Organic Carbon (TOC) Analysis For Detergent Residue Verification James G. Jin and Cheryl WoodwardTotal Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing Karen A. ClarkDetergent Selection – A First Critical Step in Developing a Validated Cleaning Program Mark AltierAnalysis Cleaning Validation Samples: What Method? Hebert J. Kaiser and Maria MinowitzControl and Monitoring...
| Special Edition | SPEQ1601 | Feb 3, 2016 1:43 pm PST

Cleaning Validation Volume IV

Delving into topics as diverse as dilution of process fluids, aseptic transfers, autoclave sterility, and medical devices, this full-length volume is a perfect introduction to cleaning for new additions to the lab, and it offers dense, new scholarship to validation managers looking to update their VMPs.______________________________________Table of Contents:Validation Case Study: Erroneous Negative Cleaning Validation Results Paul Pluta, Ph.D. Experimental Parameters for Small-scale Cleaning Characterization Part I:Dilution of Process Fluids During Cleaning Rizwan Sharnez, Ph.D., Angela...

Pharmaceutical Microbiology Toolkit

Some of the finest in pharmaceutical microbiology thought leadership is found in this comprehensive new toolkit. This toolkit features: Essential Microbiology for GXP Compliance, a test protocol to assist with low endotoxin recovery, and the past two compendia from our annual Microbiology Week events (40 presentations total!). Purchasing this toolkit unlocks all of these tools at a discount.

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| Conference Compendium | IVTQ7056 | Jun 29, 2017 8:45 am PDT

5th Annual Microbiology Week

- Use of Quality Tools to Enhance Prevention and Investigation of a Sterility Failure- Evaluation of Microbial Impact Using a Risk-Based Approach- Compare USP 71 Sterility Test Methods to Alternative Methods- Considerations in using alternative preservatives in personal care products- Move Toward a New Paradigm in Sterility Testing- Manage Contract Microbiological Testing Laboratories  And others!Download the conference compendia.
Conference Compendium | IVTQ8056 | Jun 14, 2018 10:54 am PDT

6th Annual Microbiology Week

Establish a Risk-Based Environmental Program – What Does it Entail?Ziva Abraham and Morgan Polen of Microrite, IncMicrobial Test Failure Laboratory InvestigationsTony Cundell of Microbiological Consulting, LLCHow to Recruit, Train and Retain MicrobiologistsEd Balkovic of University of Rhode Island (formerly Sanofi Genzyme)Click here to download the complete brochure. The event was sponsored by Novatek International, Millipore Sigma, Biomerieux, and Rapid Micro Biosystems.Click here to download the compendium. 
Protocol | PROQ7056 | Aug 2, 2018 7:37 am PDT

Low Endotoxin Recovery (LER) Test Protocol

Download Cheryl Platco's LER presentation  and download the LER Protocol by clicking here.  
Special Edition | SPEQ1801 | Aug 7, 2018 6:56 am PDT

Essential Microbiology for GXP Compliance

MODERN MICROBIOLOGY LABORATORY PRACTICESModern QC Microbiology Laboratory Design and Layout Considerations by Ratul SahaApproaching the Selection of Rapid Microbiological Methods by Tim SandleValidation of the Growth Direct System to Perform Pharmaceutical In-process Bioburden Analysis by Aleshia Samson, Ashley Durusky, Bill Carpenter, David L. Jones, Theresa Intinarelli  Data Integrity Considerations for the Pharmaceutical Microbiology Laboratory by Tim SandleMicrobiological Identification with MALDI-TOF MS by Tim SandleMICROBIOLOGICAL CONTROLS IN PHARMACEUTICAL MANUFACTURINGMicrobiological...

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