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
GMP - Compliance & Regulations, GMP | Conference Compendium | IVTQ6108 | Nov 15, 2016 12:00 am PST
Professionals Working in the GMP and Validation Environments met to:Understand FDA’s Quality Metrics Draft Guidance Learn how to use statistics in validationMaintain a robust cleaning and computer/software programsDevelop a Validation Master Plan (VMP) in critical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
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
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
GMP - Computer & Software | Conference Compendium | CONF0426 | Aug 3, 2016 8:41 am PDT
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
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.
Products in this Toolkit
Process Validation | Validation Master Plan | Dec 17, 2012 1:31 am PST
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.
Process Validation, Regulatory & Industry Guidance | Regulatory & Industry Guidance | RIGQ011 | Jan 6, 2013 4:02 pm PST
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...
Documentation, Process Validation | Validation Master Plan | MVPQ001 | Jan 9, 2013 8:33 am PST
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...
GMP - Qualification, Process Validation | Special Edition | SPEQ0017 | Jan 13, 2013 11:21 am PST
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...
Design and Development, Process Validation | Special Edition | SPEQ0016 | Jan 13, 2013 12:04 pm PST
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
Post Monitoring, Process Validation | Special Edition | SPEQ0018 | Jan 13, 2013 1:11 pm PST
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...
Cleaning Validation, GMP - Stability Testing | White Paper | WHTQ0001 | Jan 16, 2013 1:46 pm PST
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...
Multimedia, Process Validation | Video | IVTQ1234 | Oct 31, 2016 12:00 am PDT
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.
Sessions include:Process Validation—A Lifecycle Approach that Overcomes the Top Ten Validation ChallengesIntroduction to Statistics in Lifecycle Process ValidationImplement Quality Risk Managment (QRM) into GMP and Validation Environments Enterprise-wideLifecycle Managment of Qualification and Validation—Implement EU's Annex 15 while Harmonizing with U.S. GMPs and GuidelinesUnderstand the FDA's Quality Metrics 2015 Guidance and the Effect on Validation—What You Need to Know!Validation Sampling Plans and Acceptance CriteriaChallenges, Opportunities, and Strategies, for Green (Paperless) ValidationUnderstandDocumentation...
Cleaning Validation | Conference Compendium | IVTO6083 | Nov 15, 2016 12:00 am PST
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....
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This paper presents an overview of the validation of microbiological methods, considering some of the limitations and...
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