IVT-JVT Journal Archive

Calculations Roundtable #1: Invitation to Participate Authors: Brad Bartels, Paula L. Pluta

Compounding Forum #1: Invitation to Participate

Authors: Nishant B. Thakar, Paula L. Pluta

Vol. 28, Issue 1, Feb 2022

Shadows of Missed Opportunities In Learning Excellence Author: Lori Richter

SR #3. Data Variance, Central Tendency, and Measurement Calculations (Continued) Author: Alan M Golden

VCS #10. Cleaning Validation Equipment Sampling LocationsAuthor: Paul L. Pluta

Mycoplasma and Cell Therapy Risks

Author: Tim Sandle

An Alternative Potency Test In Mice For Porvac, A Subunit Vaccine Against Classical Swine FeverAuthors: Aymé Oliva-Cárdenas, et. al.,

COVID Face mask Contributed to Patient Death – a LASA Number Error Author: Paul L. Pluta

Vol. 27, Issue 6, Dec 2021

Biopharma Equipment Design, Qualification and Monitoring Model Author: Aja Babu Pazhayattil

CCF #2. Cleaning Terminology and Key ConsiderationsAuthor: Paul L. Pluta

SR #2 Data Variance, Central Tendency, and Measurement Calculations

Author: Alan M Golden

ICH Q9 (R1) Quality Risk Management Revision – Public Consultation Author: Paul L. Pluta

Vol. 27, Issue 5, Oct 2021

2021 IVT Award Recipients RecognizedAuthor: IVT Staff

PQ Forum #23. PQ Documents List In Validation PlanAuthor: Paul L. Pluta

The Importance of Not Being Too Attached: Pharmaceutical Equipment Characteristics and Bacterial AttachmentAuthor: Tim Sandle

MR #4. Mutual Respect Within Department TeamsAuthor: Paul L. Pluta

Critical Cleaning Forum: Invitation To ParticipateAuthor: Paul L. Pluta, Stacey L. Bruzzese

The Top 6 Risk Management Themes

Author: IVT Staff

FDA Issues Updates for Device ManufacturersAuthor: IVT Staff

Quality Plans for Pharmaceuticals and Healthcare Part 2: Adding ‘Quality’ Into ProjectsAuthor: Tim Sandle

Quality Plans for Pharmaceuticals and Healthcare Part 3: Quality-Based Structure of ProjectsAuthor: Tim Sandle

Vol. 27, Issue 4, Aug 2021

Using Cell-Based Activity Assays In Support of Carryover Calculations in Multi-Product FacilitiesAuthors: Gabriella del Hierro, Emily Holz, Ed Contreras, Pauline Che, ect.

A Risk-Based Revalidation Approach For Medical DevicesAuthors: Yeong-Lin Chen

Analysis and Case Study Review: FDA Warning letter to Tismor Health and WellnessAuthors: Orlando Lopez

PQ Forum #22. Validation Plan Document StructureAuthor: Paula L. Pluta

Risk Management: How Not To Do It Author: Siegfried Schmitt

VCS #9. Unapproved Materials From Approved SuppliersAuthor: Paula L. Pluta

Statistics Roundtable #1: Invitation To Participate; Jeremy M. EbersoleAuthors: Paula L. Pluta

Return To Office: Coronavirus, Risk, And Control Of The Indoor Environment Author: Tim Sandle

Risk Assessing The Risks: Deliverations On Risk PrioritationAuthor: Tim Sandle

PQ Forum #21 – Validation Initiation Document TemplateAuthor: Paul L. Pluta

Explicit Microsoft Excel Methods For Computerized System ValidationAuthor: Andrew Treller

Shining (Invisible) Light On Viral Pathogens: Virucidal Contamination Control Strategies Using UV-C LightAuthor: Tim Sandle

Validation of an SDS-Page Method Used to Determine Purity of Recombinant Streptokinase Extracted From Suppositories Applied in Hemorrhoidal Disease TreatmentAuthors: Ana Aguilera, José López, Gipsy Baro, José Marcelo, Yilian Bermudez, Rodolfo Valdés, Lourdes Costa

Limited Ability: Understanding the Concerns Around Microbial Methods and Sampling – BLOGAuthor: Tim Sandle

Moving Away From Animal Testing: The Case Against The Biological Reactivity Test – BlogAuthor: Tim Sandle

Vol. 27, Issue 2, Apr 2021

A Study Into the Use of Milliflex Quantum as Rapid Microbial Detection method for Microorganisms in Pharmaceutical Author: Tim Sandle

Management Roundtable #2 – Respecting EmployeesAuthor: Paula L. Pluta

PQ Forum #20. Problems Impacting PQ DocumentsAuthor: Paula L. Pluta

Audit Forum #1: Preparing for Remote GMP and GDP AuditsAuthor: Jeanne Moldenhauer

Audit Forum: Invitation To ParticipateAuthors: Jeanne Modenhauer, aul L. Pluta, Stacey L. Bruzzese

Development and Validation of an Immunoenzymatic Assay for Pig IgG Quntification in Serum SamplesAuthors: Yeleiny Machín, Yeosvany Cabrera, José Miguel Fernández, Ricardo Pina, Yoel Pérez, ect.

Statistics Roundtable #1: Invitation To ParticipateAuthor: Jeremy M. Ebersole

Digital Data #1: Content Creation – IVT BLOGAuthor: Tim Sandle

Digital Data #2: Digital Search ChallengesAuthor: IVT BLOG; Tim Sandle

Digital Data #3: Data Governance and the PatientAuthor: IVT BLOG

Biosimilar Biologic Drugs: A systematic Approach To Development, Manufacturing And Clinical ApplicationsAuthor: Kaiser Jay Aziz

Genome Editing: New, Emerging, and Interesting Developments for Clinical ApplicationsAuthor: IVT BLog; Kaiser Jay Aziz

Vol. 27, Issue 1, Feb 2021

Ionized Hydrogen Peroxide Decontamination Technology In the Vapor Form: A Solution For DecontaminationAuthor: Tim Sandle

Keeping Validation Functional and Productive During a Pandemic:Author: Ivan Soto

Lifecycle of Legacy Powder For Oral Suspension: Stage 3 Validation MonitoringAuthor: Sanjay Sharma, Amol Galande, Aja Babu Pazhayattil, and Jordan Collins

PQ Forum #19. integrated PQ DocumentsAuthor: Paula L. Pluta

Risk Analysis (FMEA) For Radio frequency Monitoring DevicesAuthor: Allan Marinelli

Steamlining Change Control: Implementing A Risk Based Change Management ProcessAuthor: Ivan Soto

Development and Application of an Immunochromatographic Strip to Monitor the Vaccination Efficacy of Vaccinated Pigs Against CSFV with E2 Protein Authors: Yeleiny Machín, Yeosvany Cabrera, José Miguel Fernández, Ricardo Pina, Yoel Pérez, Onel Valdivia, et. al.,

Principles of Parenteral Solution Validation: A Book reviewAuthor: Paul L. Pluta

Keeping Validation Functional & Productive During A PandemicAuthor: Ivan Soto

ICH Q9 (R1) Quality Risk Management RevisionAuthor: Paul L. Pluta

Changes To Analytical Equipment/Instrumentation That Are Deemed EquivalentAuthors: Emma Ramnarine, Richard Rolke

Vol. 26, Issue 5, oct 2020

Knowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge…Authors: J. Lipa, Kevin O’ Donnell, and Anne Greene

PQ Forum #17: More Word ProblemsAuthor: Paul L. Pluta

Cannabis For Medical And Pharmaceutical Purposes – Part 1: An Overview Of The Development And ApplicationAuthor: Tim Sandle

Steam Quality Testing For Non-Condensable Gases, Superheat, And Dryness – Introduction And Best PracticesAuthor: Derek Collins

Best Practices For Autoclave Validation: Steam Quality TestingAuthor: Ivan Soto

The 2020 IVT Awards a Virtual Success!Author: Stacey L. Bruzzese

Vol. 26, Issue 4, Aug 2020

Placing Patient Safety First: Developing A Disaster Plan To Reduce Risks From Covid-19 Stability Program Impacts Authors: Kim Huynh-Ba, Laure L. Larkin

Validation Case Studies and Compliance Case Studies – Invitation to ParticipateAuthor: Paul L. Pluta

Elements To Consider – Computer Systems Validation PlanAuthor: Allan Marinelli

The Regulatory Affairs Management In Smart-Working: From The Lockdown Experience To Possible Future ScenarioAuthors: Nadia Esani, Joseph Brennan

Intrinsic Compliance: A Model for Process Validation OptimisationAuthor: Cliff Campbell

Validation Of An ELISA To Quantify CBIFNΑ2.3 Monoclonal Antibody Used In Recombinant Human Alpha Interferon Accurate Quantification Authors: Yeleiny Machin, et. al.

Managing Knowledge and Risk – A Literature Review on the Interdependency of QRM and KM as ICH Q10 EnablersAuthors: Martin J. Lipa, Kevin O’Donnell, and Anne Greene

Vol. 26, Issue 3, June 2020

IVT Management Roundtable #1: Invitation To Participate – Written, Audio, Visual, And In-PersonAuthors: Paul L. Pluta, Stacey L. Bruzzese

Understanding the Concept of Formality In Quality Risk ManagementAuthors: Kevin O’Donnell, Deidre Tobin, Stephanie Butler, Ghada Haddad, and Donal Kelleher

A Letter to the FDA on Technical Considerations For Demonstrating Reliability Of Emergency-Use Injectors Submitted Under a BLA, NDA, or ANDA Authors: Paul L. Pluta, Tichard Poska

Technical Considerations for Demonstrating Reliability Of Emergency-Use Injectors: A Review Of Draft…Author: Richard Poska

The Benefits Of Utilizing A Spectrum Of Importance In IndustryAuthors: Daniel O’ Regan and Cliff Campbell

The Digital Present And The Organization Of Work: How COVID-19 Has Forced Pharma To ReorganizeAuthor: Tim Sandle

The Performance Elements Needed When Administering a Periodic IT/Automation System Evaluation ReportAuthor: Allan Marinelli

Impact Of Ligand Density On Hepatitis B Virus Surface Antigen Immunoaffinity Chromatography Efficiency and Ligand Leakage Authors: Mayte Quintana, William Ferro, Airela Llamo, Tatiana Gonzalez, et. al.,

The Survival of Coronavirus SARS-Cov-2 On Surfaces and Designing Disinfection Strategies to Eliminate the Virus Author: Tim Sandle

Validation and Application Of A Sensitive Elisa For Vip3AA Toxin Quantification In Corn Plants Resistant To Spodoptera FrugiperdaAuthors: Daily Hernández, Amarilys González, Hasel Aragón, et. al.,

Introduction to Data QualityAuthor: Orlando Lopez

Consideration of COVID-19 Prevention Measures For Those Working In GMP Pharmaceuticals and Healthcare

Vol. 26, Issue 1, Feb 2020

Eradicating Mold – It’s Not As Easy As You ThinkAuthor: Jeanne Moldenhauer

Pharmaceuticals in the EnvironmentAuthors: Natasa V ukicevic, Aneta Dimitovska, and Jelena Acevska

A Like-For-Like Change Assessment ToolAuthors: Alma O’Reilly and Donncadh nagle

Audit Trail – Standard Operating ProcedureAuthor: Allan Marinelli

PQ Forum #16. Common Word ProblemsAuthor: Paul L. Pluta

Primary Validation Of The Growth Direct Environmental Monitoring System And MediaAuthors: David L. Jones, Edwin Van Den Heuvel, Niloufar Parsaei

Rogue Biological Indicators: Are They A Real Phenomenon?Author: Tim Sandle

Building Effective CGMP Training Designed For the Adult LearnerAuthors: Lorianne Richter, Nuala Calnan