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IVT-JVT Journal Archive

June 28, 2022

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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	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 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 Pharmaceutical 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

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