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 | CNFQ0029 | Jul 23, 2013 2:22 pm PDT

GMP Week

Addressing industry’s top inspectional findings and enforcement trendsUtilizing key quality risk management methods and toolsImplementing an effective change control programMaintaining product quality monitoring and continual improvementImplementing a corrective and preventive action (CAPA) program that impresses a regulatory investigatorReducing the risk of product recalls through supply chain control and integrityDownload the GMP Week AgendaDownload the GMP Week Compendium 

Analytical Method Validation Toolkit

This toolkit highlights the most comprehensive information on analytical method validation and method development. With over 150 pages from the Journal of Validation Technology and the Journal of GXP Compliance, two hours of pre-recorded webinars, and thousands of slides from IVT's annual method validation conference, these products will ensure you keep abreast of ongoing method strategies and global regulatory trends.

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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.Download the entire 
| 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
| Conference Compendium | CNFQ0005 | Feb 28, 2013 11:38 am PST

7th Annual Method Validation

FDA’s New Process Validation Guidance: How Can It Impact Test Method Validation? Jerry Lanese, Ph.D., President, The Lanese Group LLCEnsure Method Validation Compliance through Review of FDA Warning Letters David T. Lin, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.  Enhancing Analytical Quality Through the Use of UPLC: One Method in Place of Two Corinne Mounier-Lee, Ph.D, Principal Scientist, Catalent Pharma SolutionsApplying QbD Based on Risk Assessment to Achieve a Fundamental & Practical Understanding of Method Validation Sue Mecham, Ph.D., Director of Laboratory...
| Video | VIDQ0001 | Apr 23, 2013 11:11 am PDT

Understanding the Challenges Behind QbD

In this 2009 webinar, Sam Venugopal discusses the results of CRADA's FDA-sponsored study on identifying the bottlenecks for implementation of quality by design (Qbd) in manufacturing facilities and opportunities for improvement.  Download "Understanding the Challenges Behind QbD – A Review of Leading Practices"
| Conference Compendium | CNFQ0018 | Jul 11, 2013 7:49 am PDT

8th Annual Method Validation

Establish good documentation practices and acceptance criteriafor method validationOptimize methods and effectively communicate experimental resultsHandle deviations and variations during method validationDevelop change control processes during method validationReport your validation results—Streamline the processDevelop and validate of NIR/supervised principal component analysis methodsDiscover a new experimental approach for robustness experimentsDevelop and validate of chromatographic methodsValidate and verifiy of compendial methodsDownload the 8th Annual Method Validation AgendaDownload...
| Conference Compendium | CNFQ0034 | Aug 12, 2013 8:37 am PDT

9th Annual Method Validation and Development

Hear directly from FDA and USP to Stay Abreast of Evolving Guidelines and RegulationsApply a QbD and Risk Management Approach to Method ValidationsLearn What is Needed to Update Your Methods to Today’s StandardExamine Different High Throughput Method Development StrategiesQualify Analytical InstrumentsDownload the 9th Annual Method Validation and Development AgendaDownload the 9th Annual Method Validation and Development Compendium
| 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,...
| Video | VIDQ0016 | Oct 7, 2013 12:16 pm PDT

Establishing a Valuable QbD Programme

Understand the regulators' expectations for QbDMake the business case for a QbD programUnderstand what new / additional expertise will be needed to:Establish a design spaceDescribe a design space in the submission.

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.
| Conference Compendium | CNFQ0028 | Jul 23, 2013 1:54 pm PDT

13th Annual Computer & Software Validation

Download the 13th Annual Computer & Software Validation Compendium
| Conference Compendium | CNFQ0042 | Aug 12, 2013 9:08 am PDT

14th Annual Computer and Software Validation

Deep Dive into Global Regulations–21 CFR Part 11 and Annex 11Implications of Social Media and Increased Usage of Mobile Devices on CSVNetwork Virtualization and Cloud ComputingImplementation of Exploratory TestingIncorporate flexibility into a Risk-Based Approach to CSV Company-WideMeasure the ROI that the CSV function brings to your organizationDownload the 14th Annual Computer and Software Validation AgendaDownload the 14th Annual Computer and Software Validation Compendium
| 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...

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...
| Validation Master Plan | MVPQ001 | Jan 9, 2013 8:33 am PST

Example Validation Master Plan

The purpose of the validation plan is to demonstrate that the critical equipment, systems, and processes perform as designed and intended.  All validation will be conducted prospectively following written and approved protocols.  Change control and qualification of equipment and systems will be conducted in a manner consistent with a company's policies and procedures.  Specific equipment, systems, and processes to be validated will be determined based on a documented risk assessment.  Download the example Validation Master Plan.Download the accompanying presentation "Writing...
| 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 | RECQ0001 | Nov 5, 2013 1:31 pm PST

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 | CNFQ0045 | Nov 7, 2013 10:34 am PST

19th Annual Validation Week

Validation Week is the forefront of promoting good validation practice for the last three decades. Today, new global regulations, technology advances and industry case models have shaped how to develop, implement and deploy validation procedures company-wide. Validation Week is a three-day event covering validation from A to Z, including; process, computer, equipment, method, facility, cleaning, and much more. Topics included in the 19th Annual Validation Week compendium include outlining global regulations, including FDA’s Process Validation Guidance; methodologies for streamlining the validation...
| Conference Compendium | CNFQ0035 | Feb 19, 2014 12:07 pm PST

18th Annual Validation Week

IVT's 18th Validation Week was a four-day event that covered such topics as the application of the lifecycle approach to process validation, the use of statistical analysis in process validation, global regulatory guidance for process validation, analytical instrumentation qualification, managing risk in validation, utilizing the tools and techniques of auditing, conducting gap analyses, and application of quality-by-design..Download the 18th Annual Validation Week CompendiumShort CoursesValidation Week BootcampQuality Control Lab Statistics for the Process Validation GuidanceGeneral SessionsKeep...

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