IVT Active Product List
Toolkits and Compiled Sets
Member: $895.00/Non-member: $995.00

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.

Products in this Toolkit

Member: $895.00/Non-member: $995.00

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. .

Products in this Toolkit

Member: $499.00/Non-member: $595.00

This collection of IVT Computer and Software Validation Products will guarantee compliance in the ever-changing and evolving CSV environment. With two eBooks, conference compendia, and master plans, 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 integrity.

Products in this Toolkit

Member: $495.00/Non-member: $495.00

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.

Member: $376.00 / Non-member: $595.00

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!

Products in this Toolkit

Member: $199.00/Non-member: $299.00

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.

Products in this Toolkit

Member: $700.00/Non-member: $550.00

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.

Products in this Toolkit

Member: $175.00/Non-member: $295.00

The Medical Device Validation Bundle has all you need to be prepared for your next device inspection, with our best selling products sold together at a deep discount. Valued at $1,085, this bundle provides big savings across the board - especially when you are prepared to implement medical device best practices.

Products in this Toolkit

Member: $695.00/Non-member: $895.00

This bundle is packed with tools, tips and tactics on risk management and developing a risk-based approach to quality systems. From risk analysis to risk management strategies, to creating a risk aware culture, and prioritizing cGMP Inspections of pharmaceutical manufacturing sites, these articles, presentations and podcasts covering the topic will provide today's regulations, and the industry's most progressive best practices.

SOPs & Templates
Validation Master Plans
Protocols
Special Editions

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.

Item: IVTAMV

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

Item: IVTAMVII

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: Compa

Item: IVTAMVIII

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

Item: IVTAMVIV

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...

Item: IVTCLNVALIII

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...

Item: IVTCLNVALIV

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

Item: IVTCTPSV

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...

Item: IVTCPROCVER

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...

Item: IVTEMGXPC

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

Item: IVTPROCDES

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...

Item: IVTPROCQUAL

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

Item: IVTGMPCOMPI

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

Item: IVTGMPCOMPII
Conference Compendia

3rd Annual Medical Device Validation Week

Examine key consideration in the global regulatory landscapeTackle the complexities of supplier partnerships in validation Overcome challenges in TMV for diagnosticsBuild a strategic plan for facility validation Delve into risk management in change controlUtilize risk to optimize V&V sampling plansLearn more about risk management in change control Presenters included: CAPT Kimberly Lewandowski-Walker, Senior Regulatory Officer, Office of Compliance, Division of International Compliance Operations, Medical Device Single Audit Program, CDRH, U.S. FDAAdam E. Saltman, M.D.,...

Item: IVT3AMDVW

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.

Item: IVT6AMW
Videos