Learn From Others

This segment contains a directory of, and links to, publications related to aspects of the Medical Product Stability Function.

The authors provide findings of research we may not have the resources to undertake, or they have explored a complex process (application of a new guidance, new statistical analysis method, mapping a stability chamber, etc.) and save us from not-so-obvious pitfalls when we embark on the same or similar process.

Note that some of these materials reside in commercial collections and may require membership in that organization for full access.
Topic
Title
Publication
Authors
Date
Link
Accelerated StabilityRisk-Based Predictive Stability–An Industry PerspectivePharmaceutical TechnologyHelen Williams, Dennis Stephens, Megan McMahon, Elke Debie, Fenghe Qiu, Cherokee Hoaglund Hyzer, Lois Sechler, Rachel Orr, Debra Webb, Yan Wu, David Hahn5/2/2017http://www.pharmtech.com/risk-based-predictive-stability-industry-perspective
Accelerated StabilityAn Introduction to the Accelerated Stability Assessment ProgramAmerican Pharmaceutical ReviewChristian Rack8/15/2017http://www.americanpharmaceuticalreview.com/Featured-Articles/341253-An-Introduction-to-the-Accelerated-Stability-Assessment-Program-ASAP/
Accelerated StabilityRisk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplatePharmaceutical Technology 42(8):42–47 Dennis Stephens, Helen Williams, Megan McMahon, Fenghe Qiu, Cherokee Hoaglund Hyzer, Elke Debie, Yan Wu, Hanlin Li, Jin Wang8/2/2018http://www.pharmtech.com/risk-based-predictive-stability-pharmaceutical-development-proposed-regulatory-template
Accelerated Stability Utilization of risk-based predictive stability within regulatory submissions; industry’s experienceAAPS Open 6:1Megan McMahon, Helen Williams, Elke Debie, Mingkun Fu, Robert Bujalski, Fenghe Qiu, Yan Wu, Hanlin Li, Jin Wang, Cherokee Hoaglund-Hyzer and Donnie Pulliam5/11/2020https://aapsopen.springeropen.com/articles/10.1186/s41120-020-00034-7
Accelerated StabilityAccelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry PracticesGoodReadsedited by Fenghe Qiu, Garry Scrivens5/16/2018https://www.goodreads.com/book/show/34640770-accelerated-predictive-stability-aps
Accelerated StabilityIntroducing ASAP into a new company41(3):52–57Sara Vrielynck8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
Accelerated StabilityEvaluation of Accelerated Predictive Stability: Risks and MitigationsSci of Stability ConferenceHana Prokopcova8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
Accelerated StabilityASAP for parenteral formulation development – solution and lyophilisatesSci of Stability ConferenceSabine Thielges8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
Accelerated StabilityRisk-Based Predictive Stability: Feedback from IQ Working Group Regulatory Sub-TeamSci of Stability ConferenceElke Debie8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
Accelerated StabilityAccelerated stability modeling for difficult cases: when nothing happens and when degradants degradeSci of Stability ConferenceKenneth Waterman8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
Accelerated StabilityLean Stability Case Studies: IQ Lean Stability Working GroupSci of Stability ConferenceSusan Smith8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
Accelerated StabilityApplying Arrhenius modeling to complex vaccinesSci of Stability ConferenceEls van Deventer-Troost8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
Accelerated StabilityPhysical Stability of an Amorphous Spray Dried DispersionSci of Stability ConferenceGraeme Horne,8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
Audits/InspectionsAuditing and Assessing The Quality Control LaboratoryIVT Jr GXP Compliance Vol 23 Issue 4Tim Sandle7/24/2019http://www.ivtnetwork.com/article/auditing-and-assessing-quality-control-laboratory
Audits/InspectionsAuditing Stability ProgramsCfPA WebinarJohn O'Neill6/3/2018https://www.cfpa.com/CourseDescription/CourseDescription/1802903O2801A/2801
Audits/InspectionsLaboratory Controls: Anticipate the Systems Based FDA InspectionCfPA WebinarDanielle DeLucyUnknownhttps://www.cfpa.com/CourseDescription/CourseDescription/1801902O2792A/2792
Audits/InspectionsEffective Audits in Medical DevicesIVT Jr GXP Compliance Vol 23 Issue 4Alan Golden12/22/2020https://www.ivtnetwork.com/article/effective-audits-medical-devices
Audits/InspectionsDigitization Of Validation For Effective Off-Site Regulatory “Review” and “Inspection”IVT Jr GXP Compliance Vol 23 Issue 4Siva Samy, Ajaz Hussain and Alton Johnson1/26/2021https://www.ivtnetwork.com/article/digitization-validation-effective-site-regulatory-%E2%80%9Creview%E2%80%9D-and-%E2%80%9Cinspection%E2%80%9D
Audits/InspectionsAudit Forum #1: Preparing For Remote GMP and GDP AuditsIVT Jr JVT V27I2Jeanne Moldenhauer4/27/2021https://www.ivtnetwork.com/article/audit-forum-1-preparing-remote-gmp-and-gdp-audits
Beyond Use DatingBUDs for Sterile Preparations and Stability in Compounding PharmaciesIVT Jr Val TechRick Rhoades2/23/2021https://www.ivtnetwork.com/article/buds-sterile-preparations-and-stability-compounding-pharmacies-podcast-recording
Beyond Use DatingUSP Beyond-Use Date (BUD) Provisions in General Chapters <795> and <797>USP ForumAbby Dilley9/15/2020file:///C:/Users/Stability1/Downloads/USP_Stakeholder_Engagment_Open_Forum_Presentation.pdf
Biologics/Biotech StabilityCharacterization Methods for the Physical Stability of BiopharmaceuticalsPDA Journal of Pharmaceutical Science and TechnologyDanielle DeLucy3/1/2019https://www.ncbi.nlm.nih.gov/pubmed/14765559
Biologics/Biotech Stability (new)CSL Behring Eval:New System For Cryogenic Transportation & Short-Term StorageCell & Gene art.Cytiva6/11/2021https://www.cellandgene.com/doc/csl-behring-evaluation-new-system-for-cryogenic-transportation-and-short-term-storage-0001?vm_tId=2312957&vm_nId=66130&user=b0b5fe6b-ff29-4063-822b-eda8c334f354&gdpr=0&vm_alias=Consider%20Temporary%20Cryogenic%20Storage%20Requirements&utm_source=mkt_CELL&utm_medium=email&utm_campaign=CELL_06-28-2021-Cytiva&utm_term=b0b5fe6b-ff29-4063-822b-eda8c334f354&utm_content=Consider%20Temporary%20Cryogenic%20Storage%20Requirements&mkt_tok=MDc1LU5WQy0wODYAAAF98YTS6WqM8YTuvc3qDLuD1XXrRz0wjLwwOM8GAxljCPkClb8k2dk5yZzw6kAxa1pn67jIrTmQvZEYu2dFTmpOs3RAjnp4RAzkAPTNB97MX9Y
Climate ZonesStorage Conditions for Stability Testing of Pharmaceuticals in Hot and Humid RegionsDrug Development and Industrial Pharmacy 33(4):393-401 Rubiana F Bott, Wanderley Pereira Oliveira 5/1/2017https://www.ncbi.nlm.nih.gov/pubmed/17523004
Climate ZonesClimatic Zones for Stability StudiesPharmaceutical GuidelinesAnkur Choudhary7/12/2008https://www.pharmaguideline.com/2010/12/different-climatic-zones-for-stability.html
ComplianceTechnical Writing for Compliance Part 1IVT Jr GXP Compliance Vol 23 Issue 4Paul L. Pluta, Richard Poska7/24/2019http://www.ivtnetwork.com/article/technical-writing-compliance-part-1-overview
ComplianceA Holistic Approach to Quality in the Pharmaceutical QC LaboratoryIVT Jr GXP Compliance Vol 23 Issue 3Karen Ginsbury5/23/2019http://www.ivtnetwork.com/article/holistic-approach-quality-pharmaceutical-qc-laboratory
ComplianceApplication of GMP in the Cannabis IndustryIVT Jr GXP Compliance Vol 23 Issue 3Karina Lahnakoski3/28/2019http://www.ivtnetwork.com/article/application-gmp-cannabis-industry#32hioqz
ContractorsRegulatory Impact on the Management of Pharmaceutical Contract Manufacturers (CMO’s)CfPA WebinarFrank CarrollUnknownhttps://www.cfpa.com/CourseDescription/CourseDescription/1802902O2797AF/2797
CosmeticsStability Testing Guidance for Product Safety and Shelf Life InsightCosmetics & ToiletriesKen Edwards1/3/2019https://humiditycontrol.com/stability-testing-cosmetics-shelf-life/
Data IntegrityIntroduction to Data QualityIVT Jr GXP Compliance Vol 26 Issue 2Orlando Lopez4/27/2020https://www.ivtnetwork.com/article/introduction-data-quality
Data IntegrityWhat is Data Integrity and Why is it Important?IVT Jr GXP Compliance Vol 22 Issue 5John E Lincoln2/16/2017http://www.ivtnetwork.com/article/what-data-integrity-and-why-it-important
Data IntegrityAudit Trails And Data Integrity In Pharmaceuticals And Life SciencesIVT Jr GXP Compliance Vol 24 Issue 3Ivan Soto5/26/2020https://www.ivtnetwork.com/article/audit-trails-and-data-integrity-pharmaceuticals-and-life-sciences
Data IntegrityContemporaneous Data Recording: How Does It Impact The Analytical Laboratory?IVT Jr GXP Compliance Vol 25 Iss 2Greg Vanderstel and Kim Huynh-Ba 3/24/2021https://www.ivtnetwork.com/article/contemporaneous-data-recording-how-does-it-impact-analytical-laboratory
Data IntegrityData Integrity Background and Frequently Asked QuestionsIVT Jr GXP Compliance Vol 22 Issue 5Karen Ginsbury5/30/2017http://www.ivtnetwork.com/article/data-integrity-background-and-frequently-asked-questions
Data IntegrityStability Data Integrity: Building a Governance ProgramKENX LibraryEmily S. D. Trubee6/17/20`9Request from info@kenx.org
Data Integrity Identification and Management of Critical DataIVT PodcastChris Wubbolt1/12/2021https://www.ivtnetwork.com/article/identification-and-management-critical-data
Data IntegrityMHRA Data Integrity Guidance: Implementation ApproachIVT Jr GXP Compliance Vol 22 Issue 5Ivan Soto5/30/2017https://www.ivtnetwork.com/article/mhra-data-integrity-guidance-implementation-approach
Data IntegrityClosing the Gap on Data IntegrityIVT Jr GXP Compliance Vol 22 Issue 5Scott A. Davis9/24/2018http://www.ivtnetwork.com/article/closing-gap-data-integrity
Data IntegrityData Integrity Mock Inspection - Mitigating RiskIVT Labweek Dec 2020Alyce Deegan1/13/2020https://www.ivtnetwork.com/article/data-integrity-mock-inspection-mitigating-risk
Data Integrity21 CFR Part 11 Compliance: Facts & MythsIVT webinarIvan Soto4/6/2018http://www.ivtnetwork.com/video/21-cfr-part-11-compliance-facts-myths
Data Integrity (New 10/2021)The Top Five Data Integrity Issues in GXP EnvironmentsIVT PodcastChris Wubbolt10/12/2021https://www.ivtnetwork.com/article/top-five-data-integrity-issues-gxp-environments
Data IntegrityCGMP E-Records Risk AssessmentsIVT Jr GXP Compliance Vol 22 Issue 5Orlando Lopez9/24/2018http://www.ivtnetwork.com/article/cgmp-e-records-risk-assessments
Data IntegritySpreadsheets and Data IntegrityIVT Jr GXP Compliance Vol 22 Issue 5Ivan Soto9/24/2018http://www.ivtnetwork.com/article/spreadsheets-and-data-integrity
Data IntegrityThe 5P Model for Data IntegrityIVT Jr GXP Compliance Vol 22 Issue 5Chinmoy Roy9/24/2018http://www.ivtnetwork.com/article/5p-model-data-integrity
Data IntegrityData Integrity for Your Laboratory Computerized SystemsIVT Jr GXP Compliance Vol 22 Issue 5Lynn Archambault6/7/2017http://www.ivtnetwork.com/article/data-integrity-your-laboratory-computerized-systems
Data IntegrityData Integrity Strategies for Migrating Data from Legacy SystemsIVT Jr GXP Compliance Vol 22 Issue 5Ivan Soto9/26,2017http://www.ivtnetwork.com/article/data-integrity-strategies-migrating-data-legacy-systems
DevicesLetter to FDA on Tech Considerations For Demonstrating Reliability Of Emergency-Use Injectors Submitted Under a BLA, NDA or ANDAIVT Jr GXP Compliance Vol 26, Issue 3Paul L. Pluta ,Richard Poska6/25/2020https://www.ivtnetwork.com/article/letter-fda-technical-considerations-demonstrating-reliability-emergency-use-injectors-submit
DevicesTech Considerations for Demonstrating Reliability Of Emergency-Use Injectors: A Review Of Draft FDA Guidance For IndustryIVT Jr GXP Compliance Vol 26, Issue 3Richard Poska6/25/2020file:///C:/Users/Stability1/Downloads/IVT%20Network%20-%20Technical%20Considerations%20for%20Demonstrating%20Reliability%20%20Of%20Emergency-Use%20Injectors_%20A%20Review%20Of%20Draft%20%20FDA%20Guidance%20For%20Industry%20-%202020-06-25.pdf
Disaster Planning (New 8/21)Placing Patient Safety First: Developing A Disaster Plan To Reduce Risks From Covid-19 Stability Program ImpactsIVT Jr Val TechK Huynh-ba, Laure Larkin8/26/2020https://www.ivtnetwork.com/article/placing-patient-safety-first-developing-disaster-plan-reduce-risks-covid-19-stability-progra
Electronic SystemsTransitioning from Manual to Electronic SystemsKENX LibrarySheba Zaman7/8/2019https://www.kenx.org/wp-content/uploads/2019/08/1Sheba_KENX-June-2019-transition-to-electronic-2-1.pdf
ExcursionsExcursions and In-Use: Stability Beyond ICHKENX LibraryRichard Poska6/17/2019https://www.kenx.org/wp-content/uploads/2019/08/18_MKrischKENX.FreeThink.MJK_.Talk2_.Final-1-1.pdf
ExcursionsEnvironmental Excursions and Drug Product StabilityIVT Jr GXP Compliance Vol 22 Issue 5Karen R Zimm9/19/2019http://www.ivtnetwork.com/article/environmental-excursions-and-drug-product-stability
ExcursionsChamber Excursions; Dealing with Your Chamber's VacationStabilityHubJohn O'Neill3/30/2021https://1drv.ms/p/s!AnCQXwcJJPzZjgl6Drp0BU2V6zdO?e=B7Jc0D
Field AlertsRegulatory 101 Field Alert ReportsIVT Jr GXPKaren R Zimm3/20/2020https://www.ivtnetwork.com/article/regulatory-101-field-alert-reports
Forced Degradation Pharmaceutical Stress Testing (2nd Edition)Pharmaceutical Stress Testing (Informa Healthcare)Steven W. Baertschi, Karen M. Alsante and Robert A. Reed, Editors12/31/2011https://www.taylorfrancis.com/books/e/9780429136085
Forced DegradationConducting Forced Degradation StudiesKENX LibraryGeoff Carr6/17/2019https://www.kenx.org/wp-content/uploads/2019/08/28_GCarrForced-Degradation-Studies-Handouts-9th-May-20191-1.pdf
Forced DegradationAdvanced Stability Testing and Program Management: Forced Degradation and Impurity Monitoring KENX LibraryKim Huynh-Ba6/17/2019https://www.kenx.org/wp-content/uploads/2019/08/2018_10_23_Stability-Day-2_Advanced-compressed-1.pdf
Forced DegradationZeneth: A knowledge-based system for the prediction of forced degradation of organic compoundsSci of Stability ConferenceAsh Ali8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
Forced DegradationThe Use of Safety Based Arguments to Support Degradation Product LimitsSci of Stability ConferenceDavid P. Elder8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
Forced DegradationEnrichment of Relevant Oxidative Degradation Products in Pharmaceuticals with Targeted Chemoselective OxidationSci of Stability ConferenceKausik Nanda8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
Forced DegradationAnalytical method development for the determination of drug degradation: case studiesSci of Stability ConferenceClaudio Brunelli8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
Forced DegradationDrug Photostability: The Science and Application of Photo-Produced Reactive Oxygen SpeciesSci of Stability ConferenceSteve Baertschi8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
General Stability ReferenceHandbook of Stability Testing in Pharm Dev: Regulations, Methodologies, & Best Practices Handbook of Stability Testing in Pharm Dev: Regulations, Methodologies, & Best Practices Kim Huynh-Ba, Editor1/1/2009https://www.springer.com/gp/book/9780387856261
General Stability ReferencePharmaceutical Stability Testing to Support Global Markets Pharmaceutical Stability Testing to Support Global Markets Kim Huynh-Ba, Editor1/1/2010https://www.springer.com/gp/book/9781441908889
General Stability ReferenceMethods for Stability Testing of PharmaceuticalsHumana PressSanjay Bajaj and Saranjit Singh, Editors12/31/2018https://www.springer.com/gp/book/9781493976850
General Stability ReferenceEvaluation of Stability DataHandbook of Stability Testing in Pharm Dev: Regulations, Methodologies, & Best Practices Nanda Subbarao, Kim Huynh-Bahttps://link.springer.com/chapter/10.1007%2F978-0-387-85627-8_13
Herbal Stability StudiesMPA 204T: Herbal and Cosmetic Analysis Research GateSumanta Mondal7/10/2021https://www.researchgate.net/publication/353067882_MPA_204T_HERBAL_AND_COSMETIC_ANALYSIS
In UseExcursions and In-Use: Stability Beyond ICHKENX LibraryMaria Krisch6/17/2019https://www.kenx.org/wp-content/uploads/2019/08/18_MKrischKENX.FreeThink.MJK_.Talk2_.Final-1-1.pdf
In Use Prevalence of tablet splitting in a Brazilian tertiary care hospitalPharmacy Practice 18(2):1910Vivianne Melo, Gessyka Pereira, Amanda Soares, Izabel Silva, Stephania Taveira, Marcílio Cunha-Filho, Ricardo Marreto6/1/2020https://www.researchgate.net/publication/341833291_Prevalence_of_tablet_splitting_in_a_Brazilian_tertiary_care_hospital
In Use (new 8/21)Shelf Life Assessment of Drug Product after opening Container for the first timeIJSDR1808013V3I8Bawazir et al8/1/2018https://www.ijsdr.org/papers/IJSDR1808013.pdf
Investigations Investigation of Deviations: Why Are They So Painful?IVT Jr GXP Compliance Vol. 24, Issue 4Ivan Soto7/28/2020https://www.ivtnetwork.com/article/investigation-deviations-why-are-they-so-painful
InvestigationsRoot Cause Analysis- A Systemic ApproachIVT Jr GXP Compliance Vol 22 Issue 5Ronald Snee1/23/2018http://www.ivtnetwork.com/article/root-cause-analysis-%E2%80%93-systematic-approach
InvestigationsDeviation Management - Why Have We Not Solved the Problem?IVT Jr GXP Compliance Vol 22 Issue 5David Husman1/23/2018http://www.ivtnetwork.com/article/deviation-management-why-have-we-not-solved-problem
Investigations (New 10/21)Critical Thinking #1: Why Pharmaceuticals & Healthcare Needs More Critical ThinkersIVT Jr GXP Compliance Vol 22 Issue 5Tim Sandle9/24/2021https://www.ivtnetwork.com/article/critical-thinking-1-why-pharmaceuticals-and-healthcare-needs-more-critical-thinkers-ivt-blog
Laboratory Facilitating The Lean Laboratory: A Case Study Using The 5S ApproachIVT Jr GXP Compliance Vol. 24, Issue 4Tim Sandle7/28/2020https://www.ivtnetwork.com/article/facilitating-lean-laboratory-case-study-using-5s-approach
Laboratory Laboratory sample stability. Is it possible to define a consensus stability function?De GruyterRubén Gómez Rioja ORCID logo, Débora Martínez Espartosa, Marta Segovia, Mercedes Ibarz ORCID logo, María Antonia Llopis, Josep Miquel Bauça, Itziar Marzana, Nuria Barba, Monserrat Ventura, Isabel García del Pino, Juan José Puente, Andrea Caballero, Carolina Gómez, Ana García Álvarez, María Jesús Alsina and Virtudes Álvarez5/5/2018https://www.degruyter.com/document/doi/10.1515/cclm-2017-1189/html
LaboratoryWhen Sample Temperature Matters: How to Keep Your Cool in the LabLabRootsLabCon3/15/2021https://www.labroots.com/trending/cell-and-molecular-biology/19985/sample-temperature-matters-cool-lab
Laboratory (New 7/21)Changes To Analytical Equipment/Instrumentation That Are Deemed EquivalentIVT Quality & ValidationEmma Ramnarine, Richard Rolke7/15/2021https://www.ivtnetwork.com/article/changes-analytical-equipmentinstrumentation-are-deemed-equivalent-0
LIMSStability LIMS-Selection, Implementation and ValidationKENX LibraryChris Latoz6/27/2018https://s3-us-east-2.amazonaws.com/cavettek-sites/stabilityhub/wp-content/uploads/20191108202241/KENX-Stability-Conference-June-2018-Final.pdf
MappingPlanning a Successful Warehouse Mapping StudyIVT Network.comAlex Debreceni7/23/2019http://ivtnetwork.com/article/planning-successful-warehouse-mapping-study
MethodsAnalytical Method Validation for Biopharmaceuticals, Part 1: Intro & System SuitabilityIVT Jr Val Tech Vol 22 Issue 6Drew Kelner, Ira Krull, Robert Duff, Tamer Eris12/12/2016https://www.ivtnetwork.com/article/analytical-method-validation-biopharmaceuticals-part-1-introduction-and-system-suitability
MethodsAnalytical Method Validation for Biopharmaceuticals, Part 2: Intro & System SuitabilityIVT Jr Val Tech Vol 23 Issue 1Drew Kelner, Ira Krull, Robert Duff, Tamer Eris2/12/2017https://www.ivtnetwork.com/article/analytical-method-validation-biopharmaceuticals-part-2
MethodsAnalytical Methods Validation for FDA ComplianceCFPA CourseJ. Mark Green, David E WigginsUnknownhttps://www.cfpa.com/CourseDescription/CourseDescription?Offering=0&CourseID=1887
MethodsHPLC (High Performance Liquid Chromatography): Method DevelopmentCfPA WebinarRachel MonsefUnknownhttps://www.cfpa.com/CourseDescription/CourseDescription/17119022680A/2680
MethodsHPLC (High Performance Liquid Chromatography): Method Development of Peptides and ProteinsCfPA WebinarRachel MonsefUnknownhttps://www.cfpa.com/CourseDescription/CourseDescription?Offering=17119032681A&CourseID=2681
MethodsBiopharmaceutical Analytics: Regulations and ValidationsCfPA WebinarRachel MonsefUnknownhttps://www.cfpa.com/CourseDescription/CourseDescription/1907901OP2863A/2863
MethodsCurrent Analytical Testing Methods for Cannabis and Hemp Based ProductsCFPA CourseRaghvendra SahaiUnknownhttps://www.cfpa.com/CourseDescription/CourseDescription/1907904OL2865A/2865
MethodsTest Method Selection & Spec Setting in Stability Testing for Comb Med Dev ProductsIVT Jr GXP Compliance Vol 22 Issue 6 Jian Liu, Thomas Chiesl Marika Kamberi11/1/2018http://www.ivtnetwork.com/article/test-method-selection-and-specification-setting-stability-testing-combination-medical-devi-0
MethodsSolid-State NMR to Understand Pharmaceutical StabilitySci of Stability ConferenceSteven Brown8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
MethodsIsothermal Microcalorimetry for Pharmaceutical Stability AssessmentSci of Stability ConferenceMalin Suurkuusk8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
MetricsImplimenting Quality Metrics for ValidationIVT PodcastIvan Soto4/14/2020https://www.ivtnetwork.com/article/implementing-quality-metrics-validation-0
Microbial TestingMicrobial Identification strategy for pharmaceutical microbiologyIVT Jr GXP ComplianceTim Sandle7/25/2017https://www.ivtnetwork.com/article/microbial-identification-strategy-pharmaceutical-microbiology
Microbial TestingBasic Requirement of the Bacterial Endotoxin Testing (BET) or LAL ProgramCfPA WebinarCharity Ogunsanya9/24/2019https://www.cfpa.com/CourseDescription/CourseDescription/1909903OL2567L/2567
Microbial TestingVariability and the LAL Assay for Bacterial Endotoxin DetectionIVT Jr GXP Compliance Vol 22 Issue 6 Tim Sandle9/19/2019http://www.ivtnetwork.com/article/variability-and-lal-assay-bacterial-endotoxin-detection
Microbial TestingRegulatory 101: Preservative Efficacy TestIVT Jr GXP Compliance Vol. 25, Issue 1 Karen R. Zimm1/26/2021https://www.ivtnetwork.com/article/regulatory-101-preservative-efficacy-test
Out of Specs, Trend, ExpectationOut-of-Specification & Out-ofTrend Investigations for Analytical TestingKENX LibraryEmily S. D. Trubee6/17/2019https://www.kenx.org/wp-content/uploads/2019/08/15_ETrubee_OOSOOT-Investigations-1-1.pdf
Out of Specs, Trend, ExpectationOut-of-Specification Laboratory Investigations: New Look at an Old IssueIVT Jr GXP Compliance Vol 22 Issue 6 Tim Sandle11/20/2018http://www.ivtnetwork.com/article/out-specification-laboratory-investigations-new-look-old-issue
Out of Specs, Trend, ExpectationPerforming an Effective Sterility Failure InvestigationCfPA WebinarCharity OgunsanyaUnknownhttps://www.cfpa.com/CourseDescription/CourseDescription?Offering=1709905O2766A&CourseID=2766
Out of Specs, Trend, ExpectationOut-of-Specification (OOS) Result InvestigationCfPA WebinarCharity OgunsanyaUnknownhttps://www.cfpa.com/CourseDescription/CourseDescription/1906902OL2581A/2581
PackagingUsing finite element analysis to determine blister permeability from tooling designSci of Stability ConferenceDaniel Stagnaro8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
PackagingProtective Blister Packaging Materials: Aclar®Sci of Stability ConferenceThomas Dries8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
PackagingContainer Closure Integrity Overview and USP 1207 Guidance2/1/2021https://higherlogicdownload.s3.amazonaws.com/AAPS/bfc3a388-f31c-452f-88fd-941c2a445a10/UploadedImages/Discussion_Groups_/2021AAPSCaliforniaChapter_Zecchin.pdf
PandemicStability and infectivity of coronaviruses in inanimate environmentsWorld J Clin Cases. 2020 Apr 26; 8(8): 1391–1399Shi-Yan Ren, Wen-Biao Wang, Ya-Guang Hao, Hao-Ran Zhang, Zhi-Chao Wang, Ye-Lin Chen, and Rong-Ding Gao4/26/2020https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7190947/
PharmacopoeiaPharmacopoeias: Basics for Compendial ComplianceCfPA WebinarJ. Mark WigginsUnknownhttps://www.cfpa.com/CourseDescription/CourseDescription/1707910O2773AF/2773
PharmacopoeiaPharmacopoeias: A Global Perspective for Compendial ComplianceCfPA WebinarJ. Mark WigginsUnknownhttps://www.cfpa.com/CourseDescription/CourseDescription/180727OP2728A/2728
PhotostabilityIn-Use Photostability Practice and Regulatory Evaluation for Pharmaceutical Products in an Age of Light-Emitting Diode Light Sources.J Pharm Sci.Leonardo R. Allain Brittany C. Pierce, W. Peter Wuelfing, Allen C. Templeton, Roy Helmy10/10/2018https://jpharmsci.org/article/S0022-3549(18)30600-2/pdf
PhotostabilityImplications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 3. Oral Drug ProductsJournal of Pharmaceutical Sciences May 2016 Volume 105, Issue 5, Pages 1586–1594Leonardo Allain, Steven W. Baertschi, David Clapham, Chris Foti, Wendy M. Lantaff, Robert A. Reed, Allen C. Templeton, Hanne Hjorth Tønnesen5/1/2016https://jpharmsci.org/article/S0022-3549(16)00403-2/abstract
PhotostabilityImplications of Photostability on the Mfging, Pkging, Storage & Testing of Formulated Pharmaceutical ProductsPharmaceutical Technology MARCH 2005 p. 68Allen C. Templeton, Hui Xu, Jiri Placek, and Robert A. Reed3/1/2005https://www.researchgate.net/publication/289140712_Implications_of_photos
Post ApprovalPost Approval Changes for Test Methods & Specifications in Stability Testing for Combination Products Jian LiuKENX LibraryJian Liu6/17/2019https://www.kenx.org/wp-content/uploads/2019/08/7_JLiu_1_Post-approval-changes-for-test-methods-Specifications-for-combination-products_V2_Jian-Liu_final_0531191-1-1.pdf
Process ImprovementImplement an Enjoyable Continuous Improvement Process for Your Stability FunctionKENX LibraryJohn O'Neill6/17/2019https://www.kenx.org/wp-content/uploads/2019/08/17_JOneil_-2_Implement-Enjoyable-CI-1-1.pdf
Protocols and Study DesignsDesigning Phase-Appropriate Stability Study Programs for Drug Substances and Drug ProductsPharmaceutical OutsourcingWei Pan8/9/2018https://www.pharmoutsourcing.com/Featured-Articles/352619-Designing-Phase-Appropriate-Stability-Study-Programs-for-Drug-Substances-and-Drug-Products/
Protocols and Study DesignsReduced Study Designs for Registration Stability ProgramsKENX LibraryGeoff Carr6/17/2019https://www.kenx.org/wp-content/uploads/2019/08/10_GCarr_Reduced-Study-Designs-Handouts-8th-May-20191-1-1.pdf
Protocols and Study DesignsOTC Stability Program for FDA ComplianceCFPA CourseDavid E. WigginsUnknownhttps://www.cfpa.com/CourseDescription/CourseDescription?Offering=0&CourseID=2650
Protocols and Study DesignsStability Testing for Protein Drug Products & SubstancesCFPA CoursePardeep K. GuptaUnknownhttps://www.cfpa.com/CourseDescription/CourseDescription?Offering=0&CourseID=2594
Regulations and GuidancesStability Regulations and GuidancesKENX LibraryJohn O'Neill6/17/2019https://www.kenx.org/wp-content/uploads/2019/08/2_JOneil_Stability-Regulations-and-Guidance-1-1.pdf
Regulations and GuidancesThe Eleventh Conference of the Chinese Pharmacopoeia Commission Executive Committee Held in Beijing — Review and Approve the Draft of ChP 2020 EditionNational Medical Products Administration1/1/2021http://english.nmpa.gov.cn/2020-04/13/c_500127.htm
Regulatory SubmissionsCMC Writing and Submission Strategies: A Global Regulatory ApproachCFPA CourseShrinivas (Cheenu) Murti10/10/2019https://www.cfpa.com/CourseDescription/CourseDescription/191010NJ1989/1989
Regulatory SubmissionsCMC Simulation: A Hands-on Approach to Global Marketing ApplicationsCFPA CourseShrinivas (Cheenu) Murti10/9/2019https://www.cfpa.com/CourseDescription/CourseDescription/191009NJ2634/2634
Regulatory SubmissionsFDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological ProductsCell & GeneMark Durivage7/14/2021https://www.cellandgene.com/doc/fda-releases-guidance-on-cmc-changes-to-an-approved-application-certain-biological-products-0001?vm_tId=2325790&vm_nId=66743&user=b0b5fe6b-ff29-4063-822b-eda8c334f354&gdpr=0&vm_alias=FDA%20Releases%20Guidance%20On%20Chemistry,%20Manufacturing,%20And%20Controls%20(CMC)%20Changes%20To%20An%20Approved%20Application%3A%20Certain%20Biological%20Products&utm_source=mkt_CELL&utm_medium=email&utm_campaign=CELL_08-12-2021&utm_term=b0b5fe6b-ff29-4063-822b-eda8c334f354&utm_content=FDA%20Releases%20Guidance%20On%20Chemistry,%20Manufacturing,%20And%20Controls%20(CMC)%20Changes%20To%20An%20Approved%20Application%3A%20Certain%20Biological%20Products&mkt_tok=MDc1LU5WQy0wODYAAAF-2VIlqgi6RG9BJ817h7PRqJ7fCBTpQTJJs8g0uVjg6AyeK38kRsKKeN2b2KcRMVyXHqQTF1kSUmT32KQKVkDeJ6UN9CQdx6f3PMeQR96hWPQ
Risk AssessmentRisk Assessment and Lifecycle Management in Stability TestingIVT Jr GXP Compliance Vol 22 Issue 6 Naotaka Hata9/26/2017http://www.ivtnetwork.com/article/risk-assessment-and-lifecycle-management-stability-testing
Risk Assessment Error Risk Reduction: Concept and Case StudyIVT Jr GXPTim Sandle12/16/2020https://www.ivtnetwork.com/article/error-risk-reduction-concept-and-case-study
Risk AssessmentUnderstanding the Concept of Formality In Quality Risk ManagementIVT Jr GXP Compliance Vol 26 Issue 3 Kevin O’Donnell, Deidre Tobin, Stephanie Butler, Ghada Haddad, and Donal Kelleher6/25/2020https://www.ivtnetwork.com/article/understanding-concept-formality-quality-risk-management
Risk AssessmentThe Benefits Of Utilizing A Spectrum Of Importance In IndustryIVT Jr GXP Compliance Vol 26, Issue 3Daniel O'Regan and Cliff Campbell6/25/2020https://www.ivtnetwork.com/article/benefits-utilizing-spectrum-importance-industry
Risk AssessmentICH Q( (R1) Quality Risk Management Revision IVT Jr GXPPaul L Pluta11/30/2020https://www.ivtnetwork.com/article/ich-q9-r1-quality-risk-management-revision
Risk AssessmentRisk Assessing The Risks: Deliberations On Risk PrioritizationIVT Jr GXPTim Sandle8/9/2021https://www.ivtnetwork.com/article/risk-assessing-risks-deliberations-risk-prioritization
Shelf Life Shelf-Life Extensions For Pharmaceutical Products IVT Jr GXP Compliance Vol 25, Issue 1Kevin Lombardi, Nasir Egal1/26/2021https://www.ivtnetwork.com/article/shelf-life-extensions-pharmaceutical-products-0
ShippingGood Distribution Practice For Clinical Trial MaterialsIVT Jr GXP Compliance Vol. 24, Issue 3 Andrea Zobel5/29/2020https://www.ivtnetwork.com/article/good-distribution-practice-clinical-trial-materials
ShippingStability studies needed to define the handling and transport conditions of sensitive pharmaceutical or biotechnological products.AAPS PharmSciTech. 2011 Dec;12(4):1264-75. doi: 10.1208/s12249-011-9684-0. Epub 2011 Sep 27C. Ammann9/27/2011https://www.ncbi.nlm.nih.gov/pubmed/21948319
ShippingShocking Data on Parcel Shipments of Protein Solutions.J Pharm Sci. 2020 Jan;109(1):690-695Siska C, Harber P, Kerwin BA.1/2/2020https://www.ncbi.nlm.nih.gov/pubmed/31689428
ShippingEvaluating & Qualifying Temperature Managed ShippersThermoFisher ScientificFisher Clinical Services7/1/2019https://vertassets.blob.core.windows.net/download/a8e43846/a8e43846-1647-430b-a4c3-0a387df13424/ebook_ctd_cold_chain_evaluating___qualifying_temperature_managed_shippers.pdf
ShippingQualification Versus Validation and Good Cold Chain Management PracticesPharmaceutical Manufacturing and Packing Sourcer, Autumn 2005 issue, pages 102, 104, 106. © 2005 Samedan LtdRafik H. Bishara9/1/2005https://www.semanticscholar.org/paper/Qualification-Versus-Validation-and-Good-Cold-Chain-Bishara/ec361b2c0183806848d124e9baa483344a5b0e0b
ShippingA Stability Program for the Distribution of Drug ProductsPharmaceutical Technology JULY 2004Teresa I. Lucas, Rafik H. Bishara, and Robert H. Seevers7/1/2004https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.472.8007&rep=rep1&type=pdf
SOPsDeveloping Effective ProceduresCAI E-PublicationJeff Hall & Lisa Hawkins9/1/2021https://kenx.org/wp-content/uploads/2021/09/CAI_Developing-Effective-Procedures-Whitepaper.pdf?utm_source=Article%20Downloads&utm_medium=email&utm_campaign=Ops%20Readiness%205%20-%20Complimentary%20Webinar%20-%20Developing%20Effective%20Procedures%20%28UQdXer%29&_kx=SLU5Vpxfb_6kRxVDfKbeyHPkeZBC5DzHopYSspANdBg%3D.X3EpUs
Stability ConceptsStability Studies and Testing of Pharmaceuticals - An OverviewLCGC NA V-38 I-6 p325-336Michael Dong, Kim Huynh-Ba6/1/2020https://www.chromatographyonline.com/view/stability-studies-and-testing-pharmaceuticals-overview
Stability ConceptsEffect of Drug Load and Surface Area on Degradation Rate in SolidsSci of Stability ConferenceGary Scrivens8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
Stability ConceptsAn holistic approach to profound product understandingSci of Stability ConferenceNA8/14/2019https://freethinktech.com/sos-2019-slide-presentations/
Stability Concepts How to Optimize Your Stability Program at Each Phase of Drug Development.Pharmaceutical online Michael W. Dong4/18/2017https://www.pharmaceuticalonline.com/doc/how-to-optimize-your-stability-program-at-each-phase-of-drug-development-0001
Stability Concepts Designing Phase-Appropriate Stability Study Programs for Drug Substances and Drug ProductsPharmaceutical Outsourcing, Kim Huynh-Ba8/9/2018https://www.pharmoutsourcing.com/Featured-Articles/352619-Designing-Phase-Appropriate-Stability-Study-Programs-for-Drug-Substances-and-Drug-Products/
Stability ProgramsStability Testing and Program Management RoadmapKENX LibraryKim Huynh-Ba6/17/2019https://www.kenx.org/wp-content/uploads/2019/08/2018_10_22_Stability_Day-1_Roadmap-compressed-1.pdf
Stability ProgramsMedical Product Stability Function OverviewCfPA WebinarJohn O'Neill6/4/2018https://www.cfpa.com/CourseDescription/CourseDescription/1901907OL2846A/2846
Stability ProgramsStability Testing – Doing Everything or Doing the Right Thing?American Pharmaceutical ReviewJon V. Beaman8/1/2010https://www.americanpharmaceuticalreview.com/Featured-Articles/116169-Stability-Testing-Doing-Everything-or-Doing-the-Right-Thing/
Stability ProgramsStability Studies and Testing of Pharmaceuticals: An OverviewInternational Pharmaceutical AcademyKim Huynh-Ba & Michael W. Dong6/10/2020https://ipacanada.com/stability-studies-and-testing-of-pharmaceuticals-an-overview/
StatisticsEstablishing the Shelf Life of Pharmaceutical Products (PDF)pqri.org stability shelf lifePQRI Stability-shelf-life Working Group7/8/2008http://pqri.org/stability-shelf-life-working-group/
StatisticsStatistical Considerations for Stability and the Estimation of Shelf LifeChapter from book Nonclinical Statistics for Pharma & Biotech Industries (pp.575-604)Walter W. Stroup, Michelle Quinlan1/1/2016https://www.springer.com/gp/book/9783319235578
StatisticsStatistical Process Control and the Use of Control Charts Using Statistics to Identify and Understand Procss Capability, Stability and ControlKENX LibraryDouglas B. Brown6/17/2019https://www.kenx.org/wp-content/uploads/2019/08/32_DBrown_KENX-2019-Philadelphia-Stab-Test-Prog-Mngmnt-Day-3-1030AM-DBB5-2-1.pdf
StatisticsStability Shelf Life Working Group-Product Quality Research Institutepqri.org stability shelf lifePQRI Stability-shelf-life Working Group7/8/2008http://pqri.org/stability-shelf-life-working-group/
StatisticsSSLWG Glossary Version 1.0 (PDF)pqri.org stability shelf lifePQRI Stability-shelf-life Working Group7/8/2008http://pqri.org/wp-content/uploads/2016/07/SSLWG_Glossary_Ver_1-0.pdf
StatisticsPQRI SSL WG Update Webinar Presentation – 08 July 2008 (PDF)pqri.org stability shelf lifeSchwenke, Forenzo, Stroup7/8/2008http://pqri.org/wp-content/uploads/2016/07/PQRI_SSL_WG_Webinar_Presentation_-_08_July_2008.pdf
StatisticsDirect Approaches to Shelf Life Estimation (Presentation Slides) (PDF)pqri.org stability shelf lifeQuinlan, Schwenke, Stroup7/8/2008http://pqri.org/wp-content/uploads/2016/07/JSM_2008_-_Michelle_Presentation.pdf
StatisticsDirect Approaches to Shelf Life Estimation (Poster) (PDF)pqri.org stability shelf lifeQuinlan, Schwenke, Stroup7/8/2008http://pqri.org/wp-content/uploads/2016/07/Quinlan_-_Poster_-_Shelf_Life_Estimation.pdf
StatisticsEvaluating Tolerance Interval Estimates: To Capture or Not to Capture (Slides) (PDF)pqri.org stability shelf lifeQuinlan, Schwenke, Stroup7/8/2008http://pqri.org/wp-content/uploads/2016/07/Quinlan_-_Presentation_-_Tolerance_Intervals.pdf
StatisticsProposed Methodology for Shelf Life Estimation (Presentation Slides) (PDF)pqri.org stability shelf lifeQuinlan, Schwenke, Stroup7/8/2008http://pqri.org/wp-content/uploads/2016/07/2009_MBSW.pdf
StatisticsEstimating Shelf Life Using Quantile Regression with Random Batch Effects (Slides) (PDF)pqri.org stability shelf lifeQuinlan, Schwenke, Stroup8/5/2009http://pqri.org/wp-content/uploads/2016/07/JSM_2009_v3.pdf
StatisticsComparing Statistical Interval Estimates (Presentation Slides) (PDF)pqri.org stability shelf lifeQuinlan, Schwenke, Stroup7/8/2008http://pqri.org/wp-content/uploads/2016/07/2008_ENAR.pdf
StatisticsReconsidering Shelf Life: An Update from the PQRI Stability Shelf Life WG (Slides/PDF)pqri.org stability shelf lifeSchwenke, Forenzo7/8/2008http://pqri.org/wp-content/uploads/2016/07/2008_MBSW_Presentation.pdf
StatisticsNon-Clinical Statistics Conference:Update from the PQRI Stability Shelf Life WG Slides/PDFpqri.org stability shelf lifeSchwenke9/23/2008http://pqri.org/wp-content/uploads/2016/07/2008_Nonclinical_Meetings_-_Belgium.pdf
StatisticsShelf Life Determination: The PQRI Stability Shelf Life WG Initiative (Slides/PDF)pqri.org stability shelf lifePQRI Stability-shelf-life Working Group7/8/2008http://pqri.org/wp-content/uploads/2016/07/2009_FDA-Industry_Workshop_Panel_Discussion.pdf
StatisticsNew Approaches to Stability Testing (Presentation Slides) (PDF)pqri.org stability shelf lifePQRI Stability-shelf-life Working Group7/8/2008http://pqri.org/wp-content/uploads/2016/07/2009_PhRMA_Leaders_Meeting_-_Shelf_Life.pdf
StatisticsAre You Uncertain About Uncertainty?IVT Jr GXP Compliance Vol 22 Issue 6 William Porter5/30/2017http://www.ivtnetwork.com/article/are-you-uncertain-about-uncertainty
SterilitySterilization and Sterility Assurance in Medical Device PackagingIVT Voices in Validation PodcastRoberta Goode3/2/2021https://www.ivtnetwork.com/article/sterilization-and-sterility-assurance-medical-device-packaging
ToxicsDeath by Licorice? Unexpected Toxicity From Drug ProductsIVT Jr GXP Vol 25 Issue 2Paul Pluta3/9/2021https://www.ivtnetwork.com/article/death-licorice-unexpected-toxicity-drug-products-0
Training & EducationBest Practices in trainingIVT Jr GXP Compliance Vol 22 Issue 6 Lorianne Richter, Anne Greene9/19/2019http://www.ivtnetwork.com/article/understanding-adult-learning-principles-cgmp-training-modalities-and-pharmaceutical-regulato
ValidationWriting Pharmaceutical Equipment Qualification ProtocolsIVT Jr GXP Compliance Vol 22 Issue 5Joe Cagnassola, Paul Copus, Keith Haynes9/24/2018http://www.ivtnetwork.com/article/writing-pharmaceutical-equipment-qualification-protocols
ValidationApplication Of Wireless Technology In The Pharmaceuticals Sector: Maintaining Data Integrity, Security And PrivacyIVT Jr GXP Compliance Vol 24, Issue 3Tim Sandle5/26/2020https://www.ivtnetwork.com/article/application-wireless-technology-pharmaceuticals-sector-maintaining-data-integrity-security-a
ValidationIntegrated PQ DocumentsIVT Jr ValTech Vol 27, Issue 1Paul Pluta2/23/2021https://www.ivtnetwork.com/article/pq-forum-19-integrated-pq-documents
ValidationConnected Device System Validation & Quality - Best PracticesIVT Jr Val TechCarolyn Wright8/28/2017https://www.ivtnetwork.com/article/connected-device-system-validation-quality-best-practices
ValidationKeeping Validation Functional and Productive During a PandemicIVT Jr Val TechIvan Soto2/23/2021https://www.ivtnetwork.com/article/keeping-validation-functional-and-productive-during-pandemic
ValidationFAQ – Statistics in ValidationIVT Jr Val TechRoberta Goode7/5/2017https://www.ivtnetwork.com/article/faq-statistics-validation