These special editions discuss all three stage of process validation, design, qualification, and verification, outlined in the US Food and Drug Administration FDA Process Validation Guidance. These special editions will help professionals implement compliant process validation, cleaning validation, method validation, and equipment and facility qualification.
Products in this Toolkit
GMP - Qualification, Process Validation | Special Edition | SPEQ0017 | Jan 13, 2013 11:21 am PST
Design and Execution of a Shipping Qualification for a Vaccine Drug Substance
Jamison Tull and Brian K. NunnallyEngineering Runs: An Insider’s Perspective
Charlie Neal, Jr.Improving Validation Through the Use of Confidence Statements Based on Attributes Acceptance Sampling
John HauryOriginal Data Supporting PQ
Paul L. PlutaPQ Documentation-Three Simple Rules
Paul L. PlutaReduced Validation Effort—Approaches Used and Lessons Learned
Elaine Kelleher and
Design and Development, Process Validation | Special Edition | SPEQ0016 | Jan 13, 2013 12:04 pm PST
FDA Lifecycle Approach to Process Validation—What, Why, and How?
Paul L. PlutaFirst Steps in Experimental Design—The Screening Experiment
John A. WassFirst Steps in Experimental Design II: More on Screening Experiments
John A. WassA Further Step in Experimental Design (III): The Response Surface
John A. Wass
Post Monitoring, Process Validation | Special Edition | SPEQ0018 | Jan 13, 2013 1:11 pm PST
Compliance Case Study #5—Secondary Packages With Defective Glue Joints
D. Wylie McVay, Jr.Dos and Don’ts of Control Charting—Part I
John McConnell, Brian K. Nunnally, and Bernard McGarveyThe Dos and Don’ts of Control Charting—Part II
John McConnell, Brian Nunnally, and Bernard McGarveyGMP Monitoring—What, Why, Where, and How
Gamal AmerHaving It All
John McConnell, Brian K. Nunnally, and Bernard McGarvey
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
GMP, Multimedia | Video | VIDQ0007 | Oct 16, 2012 4:28 am PDT
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.
GMP | Special Edition | SPEQ0014 | Jan 8, 2013 2:50 pm PST
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
GMP - Training, GMP | Special Edition | SPEQ0015 | Jan 18, 2013 12:28 pm PST
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
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
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.
Products in this Toolkit
GMP - Method Development, Method Validation | Special Edition | SPEQ0002 | Jan 17, 2013 1:32 pm PST
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
GMP - Method Development, Method Validation | Special Edition | SPEQ0003 | Jan 17, 2013 1:47 pm PST
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
Method Validation | Conference Compendium | CNFQ0005 | Feb 28, 2013 11:38 am PST
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...
QbD, GMP - Method Development | Video | VIDQ0001 | Apr 23, 2013 11:11 am PDT
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"
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...
GMP - Method Development, Method Validation | Conference Compendium | CNFQ0034 | Aug 12, 2013 8:37 am PDT
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
GMP - Method Development, Method Validation | Special Edition | SPEQ0021 | Oct 7, 2013 12:02 pm PDT
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,...
QbD, Method Validation | Video | VIDQ0016 | Oct 7, 2013 12:16 pm PDT
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.
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
Products in this Toolkit
Computer & Software Validation | Special Edition | SPEQ0005 | Jan 11, 2013 7:54 am PST
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
Computer & Software Validation, Multimedia | Video | VIDQ0015 | Jan 23, 2013 12:38 pm PST
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.
Virtual Networks, Multimedia | Video | VIDQ0012 | Jan 24, 2013 1:35 pm PST
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
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
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Next year will mark 20 years since the first Validation Week. Since then, Validation Week has made its home in Philadelphia, San Diego, San Juan, Amsterdam, Copenhagen, Dublin, Singapore, and Toronto. Now, we ask you: where is the best place for Validation Week in 2014?
Northeast USA (Philadelphia/Washington D.C./Boston)
The Journal of Validation Technology and the Journal of GXP Compliance are the top peer-reviewed industry journals. The editorial staff includes a mixture of knowledgeable industry and publishing professionals.
IVT Network members are entitled to a discount to any of IVT's thought-provoking conferences. Furthemore, at the event, you recieve the complete compendium, as well as special networking opportunities!
BioPharm International magazine integrates the science and business of biopharmaceutical research, development and manufacturing. It provides practical peer-reviewed technical solutions to enable biopharmaceutical professionals to perform their jobs more effectively.
LCGC North America, LCGC Europe, and LCGC Asia-Pacific are the premier source of peer-reviewed technical information on the field of chromatography. They deliver practical information to help scientists and lab managers become more proficient in the use of chromatographic techniques.
CBI provides market-driven conferences for the pharmaceutical, biotechnology, medical device, and healthcare industries. It offers information presented in interactive formats from thought leaders and regulators and extensive opportunities for networking and discussion.
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