IVT-JVT Journal Archive

Journal of Validation Technology Archive

Vol. 28, Issue 2, Apr 2022
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 Locations

Author: 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 Fever

Authors: 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 Considerations

Author: Paul L. Pluta

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 Recognized

Author: IVT Staff

PQ Forum #23. PQ Documents List In Validation Plan

Author: Paul L. Pluta

The Importance of Not Being Too Attached: Pharmaceutical Equipment Characteristics and Bacterial Attachment

Author: Tim Sandle

MR #4. Mutual Respect Within Department Teams

Author: Paul L. Pluta

Critical Cleaning Forum: Invitation To Participate

Author: Paul L. Pluta, Stacey L. Bruzzese

The Top 6 Risk Management Themes

Author: IVT Staff

FDA Issues Updates for Device Manufacturers

Author: IVT Staff

Quality Plans for Pharmaceuticals and Healthcare Part 2: Adding ‘Quality’ Into Projects

Author: Tim Sandle

Quality Plans for Pharmaceuticals and Healthcare Part 3: Quality-Based Structure of Projects

Author: Tim Sandle
Vol. 27, Issue 4, Aug 2021

Using Cell-Based Activity Assays In Support of Carryover Calculations in Multi-Product Facilities

Authors: Gabriella del Hierro, Emily Holz, Ed Contreras, Pauline Che, ect.

A Risk-Based Revalidation Approach For Medical Devices

Authors: Yeong-Lin Chen

Analysis and Case Study Review: FDA Warning letter to Tismor Health and Wellness

Authors: Orlando Lopez

PQ Forum #22. Validation Plan Document Structure

Author: Paula L. Pluta

Risk Management: How Not To Do It

Author: Siegfried Schmitt

VCS #9. Unapproved Materials From Approved Suppliers

Author: Paula L. Pluta

Statistics Roundtable #1: Invitation To Participate; Jeremy M. Ebersole

Authors: Paula L. Pluta

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

Author: Tim Sandle

Risk Assessing The Risks: Deliverations On Risk Prioritation

Author: Tim Sandle
Vol. 27, Issue 3, Jul 2021    

Getting There: Strategies To Improve Gender Equality In Pharmaceuticals and Healthcare

Author: Tim Sandle

How to Ensure Senior Management Approval For Your Next Regulate IT System

Author: David Harris

How to Implement the ISPE Commissioning and Qualification Baseline Guide

Author: Ivan Soto

PQ Forum #21 – Validation Initiation Document Template

Author: Paul L. Pluta

Explicit Microsoft Excel Methods For Computerized System Validation

Author: Andrew Treller

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

Author: Tim Sandle

Validation of an SDS-Page Method Used to Determine Purity of Recombinant Streptokinase Extracted From Suppositories Applied in Hemorrhoidal Disease Treatment

Authors: Ana Aguilera, José López, Gipsy Baro, José Marcelo, Yilian Bermudez, Rodolfo Valdés, Lourdes Costa

Limited Ability: Understanding the Concerns Around Microbial Methods and Sampling – BLOG

Author: Tim Sandle

Moving Away From Animal Testing: The Case Against The Biological Reactivity Test – Blog

Author: Tim Sandle
Vol. 27, Issue 2, Apr 2021

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

Management Roundtable #2 – Respecting Employees

Author: Paula L. Pluta

PQ Forum #20. Problems Impacting PQ Documents

Author: Paula L. Pluta

Audit Forum #1: Preparing for Remote GMP and GDP Audits

Author: Jeanne Moldenhauer

Audit Forum: Invitation To Participate

Authors: Jeanne Modenhauer, aul L. Pluta, Stacey L. Bruzzese

Development and Validation of an Immunoenzymatic Assay for Pig IgG Quntification in Serum Samples

Authors: Yeleiny Machín, Yeosvany Cabrera, José Miguel Fernández, Ricardo Pina, Yoel Pérez, ect.

Statistics Roundtable #1: Invitation To Participate

Author: Jeremy M. Ebersole

Digital Data #1: Content Creation – IVT BLOG

Author: Tim Sandle

Digital Data #2: Digital Search Challenges

Author: IVT BLOG; Tim Sandle

Digital Data #3: Data Governance and the Patient

Author: IVT BLOG

Biosimilar Biologic Drugs: A systematic Approach To Development, Manufacturing And Clinical Applications

Author: Kaiser Jay Aziz

Genome Editing: New, Emerging, and Interesting Developments for Clinical Applications

Author: IVT BLog; Kaiser Jay Aziz
Vol. 27, Issue 1, Feb 2021

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

Author: Tim Sandle

Keeping Validation Functional and Productive During a Pandemic:

Author: Ivan Soto

Lifecycle of Legacy Powder For Oral Suspension: Stage 3 Validation Monitoring

Author: Sanjay Sharma, Amol Galande, Aja Babu Pazhayattil, and Jordan Collins

PQ Forum #19. integrated PQ Documents

Author: Paula L. Pluta

Risk Analysis (FMEA) For Radio frequency Monitoring Devices

Author: Allan Marinelli

Steamlining Change Control: Implementing A Risk Based Change Management Process

Author: 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 review

Author: Paul L. Pluta

Vol. 26, Issue 6, dec 2020


PQ Forum #18. PV Stage 1 Technical Report Format

Author: Paul L. Pluta

Shelf-Life Extensions For Pharmaceutical Product

Authors: Kevin Lombardim, Nasir Egal

CF #5: Team Member Traits In Virtual Pharma Project Teams – Emphasis On Personal Attributes

Author: Allan Marinelli

Keeping Validation Functional & Productive During A Pandemic

Author: Ivan Soto

ICH Q9 (R1) Quality Risk Management Revision

Author: Paul L. Pluta

Changes To Analytical Equipment/Instrumentation That Are Deemed Equivalent

Authors: 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 Problems

Author: Paul L. Pluta

Cannabis For Medical And Pharmaceutical Purposes – Part 1: An Overview Of The Development And Application

Author: Tim Sandle

Steam Quality Testing For Non-Condensable Gases, Superheat, And Dryness – Introduction And Best Practices

Author: Derek Collins

Best Practices For Autoclave Validation: Steam Quality Testing

Author: 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 Participate

Author: Paul L. Pluta

Elements To Consider – Computer Systems Validation Plan

Author: Allan Marinelli

The Regulatory Affairs Management In Smart-Working: From The Lockdown Experience To Possible Future Scenario

Authors: Nadia Esani, Joseph Brennan

Intrinsic Compliance: A Model for Process Validation Optimisation

Author: 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 Enablers

Authors: 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-Person

Authors: Paul L. Pluta, Stacey L. Bruzzese

Understanding the Concept of Formality In Quality Risk Management

Authors: 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 Industry

Authors: Daniel O’ Regan and Cliff Campbell

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

Author: Tim Sandle

The Performance Elements Needed When Administering a Periodic IT/Automation System Evaluation Report

Author: 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.,

Vol. 26, Issue 2, Apr 2020


CQV# 9: What, How, and Why of Handwashing

Author: Paul L. Pluta

Lessons Learned During The Coronavirus – Covid-19 (SARS-CoV-2) Pandemic

Author: Stacey L. Bruzzese

Reducing the Cost Of Sterilization Validation: Aligning With USP 1229.5

Author: Ivan Soto

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 Frugiperda

Authors: Daily Hernández, Amarilys González, Hasel Aragón, et. al.,

Introduction to Data Quality

Author: 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 Think

Author: Jeanne Moldenhauer

Pharmaceuticals in the Environment

Authors: Natasa V ukicevic, Aneta Dimitovska, and Jelena Acevska

A Like-For-Like Change Assessment Tool

Authors: Alma O’Reilly and Donncadh nagle

Audit Trail – Standard Operating Procedure

Author: Allan Marinelli

PQ Forum #16. Common Word Problems

Author: Paul L. Pluta

Primary Validation Of The Growth Direct Environmental Monitoring System And Media

Authors: 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 Learner

Authors: Lorianne Richter, Nuala Calnan