Avoiding Errors With The Batch Release Process: Best Practice CGMPs
Author: Tim Sandle |
Medication Safety – Pharma Industry Considerations Questions From Readers #2
Author: Paul L. Pluta |
 Calculations Roundtable #1: Invitation To Participate; Nishant B. Thakar
Author: Paul L. Pluta |
FDA Seek Comments on Quality System (QS) Regulations Amendments
Author: IVT Staff |
Quality Plans for Pharmaceuticals and Healthcare: Checking the Maturity of Your Quality System
Author: Tim Sandle |
Critical Thinking #4: Presenting Scientific Data Clearly and With Purpose
Author: Tim Sandle |
Digital Data #4: Looking for Data Trends and Patterns With Visualization
Author: Tim Sandle |
ICH Q9 Quality Risk Management Revision |
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Vol. 26, Issue 1, Jan 2022
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Compliance Case Study #19: Primary Container Problems
Authors: Paul L. Pluta and Alan M. Mancini |
Medication Safety – Pharma Industry Considerations Part 3 – High Alert Medications |
Shadows of Missed Opportunities in Learning Excellence
Author: Lori Richter |
What the Eye Can See: Vision Requirements for Personnel Who Inspect Injectable Pharmaceuticals
Author: Tim Sandle |
Data Integrity Strategy Document Essentials
Author: Orlando Lopez |
Membrane Filter Pore Size Selection For Microbial Testing
Authors: Nilesh Shah and Madhuri Powar |
Regulatory 101: Safety of Titanium Dioxide
Authors: Karen R. Zimm, Renee Phillips |
Investigations For Production Areas
Author: Jeanne Modenhauer |
Managing Workplace Error Part 1: Unpicking Patterns of Human Error
Author: Tim Sandle |
Vol. 25, Issue 6, Nov 2021
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Animal-Derived Ingredients, FDA, and Regulations
Authors: Karen R. Zimm, Renee Phillips |
Application of Validation Principles to the Training Quality System Part 8 – Training Process Documentation
Author: Paul L. Pluta |
Improving Microbiological Control Of Non-Sterile Pharmaceuticals: Unlocking The FDA Guidance
Author: Tim Sandle |
Setting Internal Limits And Its Application For Microorganisms Of Concern In Non-Sterile Pharmaceuticals
Author: Ratul Saha |
Audit Forum – Audit Trails
Author: Jeanne Moldenhauer |
CCS #18: Culture vs. Compliance
Author: Paul L. Pluta |
Vol. 25, Issue 5, Sep 2021
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Management Roundtable #3: Lessons From Restaurant Dishwashing
Author: Paul L. Pluta |
Monte Carlo Simulation Using Microsoft Excel to Estimate the Probability of Passing USP Dissolution Test
Author: Prasanth Sambaraju |
The Importance of Not Being Too Attached: Pharmaceutical Equipment Characteristics and Bacterial Attchment
Author: Tim Sandle |
A Contamination Control Strategy Gone Wrong
Author: Jeanne Moldenhauer |
 Regulatory 101: Bulk Holding Time Requirements
Author: Karen R. Zimm, Renee Phillips |
Critical Thinking #1: Why Pharmaceuticals and Healthcare Needs More Critical Thinkers – IVT BLOG
Author: Tim Sandle |
Critical Thinking #2: Reading Research Papers – IVT BLOG
Author: Tim Sandle |
Critical Thinking #3: Developing Questions to Achieve the Optimal Outcome – IVT BLOG
Author: Tim Sandle |
CRISPR Therapeutics: New Emerging Developments and Clinical Applications – IVT BLOG
Author: Kaiser Jay Aziz |
Vol. 25, Issue 4, Jul 2021
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E-Records Integrity – Data Warehouse And Data Mart Layer
Author: Orlando Lopez |
Good Practices For Managing A Safe Chemical laboratory Part 4: Records, Documents And Regulations
Author: Kurt L. Moyer, Richard C. Wedlich |
Application of Validation Principles To The Training Quality System Part 7 – Training Management Overview
Author: Paul L. Pluta |
Audit Forum: Lessons From previous FDA Observations – Drugs
Author: Jeanne Moldenhauer |
Regulatory 101: What Do the cGMP Regulations Say About Recalls?
Author: Karen R. Zimm, Renee Phillips |
Getting There: Strategies To Improve Gender Equality In Pharmaceuticals and Healthcare
Author: Tim Sandle |
How To Ensure Senior Management Approval For Your Next Regulated IT System
Author: David Harris |
Shining (Invisible) Light on Viral Pathogens: Virucidal Contamination Control Strategies Using UV-C Light
Author: Tim Sandle |
Gene Therapy: Development, Design of Studies, and Approval Process – BLOG
Author: Kaiser Jay Aziz |
Vol. 25, Issue 3, May 2021
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Audit Forum: Invitation To Participate
Author: Jeanne Moldenhauer, Paul L. Pluta, Stacey L. Bruzzese |
Face Mask Controls and Duration of Wearing: What Medical Research Can Teach the Cleanroom Manager
Author: Tim Sandle |
Regulatory 101: Drug Names – Reader Q&A
Author: Paul L. Pluta |
 Statistics Roundtable #1: Invitation To Participate
Jeremy M. Ebersole |
A Humidex For the Cleanroom: Why Temperature And Humidity Control Matters
Author: Tim Sandle |
Good Practices for Managing a Safe Chemical Laboratory Part 3: Safety Administration and Facilities
Author: Richard C. Wedlich, Ulyana Matyugicheva |
Audit Forum #1: Preparing For Remote GMP and GDP Audits
Author: Jeanne Moldenhauer |
IVT Veteran Honored With Induction to Florida Inventors Hall of Fame
Author: Stacey L. Bruzzese |
Updates Published for ICH E6 GCP Guideline: GMP for IMP Principles
Author: Stacey L. Bruzzese |
 Ventilators Dumped in Miami – Blog
Author: Vladimir Gostuski |
Wearable Devices and Usage – BLOG
Author: Emilia N. Faraj |
Risk-Benefit Analysis of the FDA’s Decision to pause J&J Vaccine – BLOG
Author: Coralin Nogues |
Vol. 25, Issue 2, Mar 2021
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Anatomy of a Contamination Control Strategy for Sterile Manufacturing
Author: Tim Sandle |
Comtemporaneous Data Recording: How Does It Impact The Analytical Laboratory?
Author: Greg Vanderstel and Kim Huynh-Ba |
 Compliance Case Study #17: Spots On Tablets – An Investigation
Authors: Alan M. Mancini, Paul L. Pluta |
Good Practices For Managing A Safe Chemical Laboratory Part 2: Safety Management Strategies
Authors: Richard C. Wedlich, ZemElia Miller |
 Regulatory 101: Biologic Non-Proprietary Drug Names – Terminology and Format
Authors: Karolina Cieslak, Paul L. Pluta |
An Alternative Approach To Decontamination Of Beta-Lactam Antibiotic Residues With A Globally Available
Authors: Seth Robinson, Paul Lopolito, Elizabeth Rivera, Beth Kroeger-Gahnestock |
Management Roundtable #1: Invitation To Participate
Authors: Paul L. Pluta, Stacey L. Bruzzese |
Principles of Parental Solution Validation: A Book Review
Author: Paul L. Pluta |
Temperature Scanners: Limited Value in Detecting Employee COVID-19 Symptoms?
Author: Tim Sandle |
Vol. 25, Issue 1, Jan 2021
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Cleanrooms and Associated Controlled Environments – Biocontamination Control: Dissecting The Standard
Author: Tim Sandle |
Digitization of Validation For Effective Off-Site Regulatory “Review” and “Inspection”
Authors:Siva Samy, Ajaz Hussain, Alton Johnson |
Good Practices For Managing A Safe Chemical Laboratory Part 1: People And Human Resources
Authors: Richard C. Wedlich and Kurt L. Moyer |
Medical Cannabis as a Pharmaceutical – Part 3: Microbiological Risk and Quality Control
Author: Tim Sandle |
Medication Safety and Drug names – Valproic Acid Product Problems; Marisol Avalos
Author: Paul L. Pluta |
 Regulatory 101: Preservative Efficacy Test
Author: Karen R. Zimm |
Changes To Analytical Equipment/Instrumentation That Are Deemed Equivalent; Emma Ramnarine
Author: Richard Rolke |
Shelf-Life Extensions For Pharmaceutical Products; Kevin Lombardi
Author: Nasir Egal |
Crest of a Wave? Innovations with Personalized Medicine – BLOG POST
Author: Tim Sandle |
| Vol. 24, Issue 6, Nov 2020 |
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Compliance Cast Study #16: Microbial contamination From Foods |
ICH Q9 (R1) Quality Risk Management Revision
Author: Paul L. Pluta |
Cannabis For Medical And Pharmaceutical Purposes – Part 1: An Overview Of The Development And Application
Author: Tim Sandle |
Cannabis For medical And Pharmaceutical Purposes- Part 2: Analytical Quality Control
Author: Tim Sandle |
Regulatory 101: The Basics of Post Approval/Variation Submissions In United States And European Union
Authors: Karen R. Zim and Renee King-Alliego |
Application of Validation Principles to The Training Quality System. Part 6, Continued Training Verification
Author: Paul L. Pluta |
Knowledge As The Currency Of Managing Risk: A Novel Framework To unite Quality Risk Management And Knowledge
Authors: Martin J. Lipa, Kevin O’Donnell, and Anne Greene |
Restarting Your Facility – When Disaster Strikes
Author: Jeanne Moldenhauer |
Microbial Contamination Concerns linked with E-Cigarettes and Vaping Products – A Blog Post from IVT Network
Author: Tim Sandle |
Unexpected Toxicity From Drug Products – A blog post from IVT network
Author: Paul L. Pluta |
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| Vol. 24, Issue 5, Sep 2020 |
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26th Annual validation Week – All new Format, Same Trusted Thought Leadership
Author: Stacey L. Bruzzese |
CQV #10: More Like for Like Problems
Author: Paul L. Pluta |
Alternative Risks To Cleanrooms Presented By People: Tattoos, Piercings, Sunbeds
Author: Tim Sandle |
Implementing Adequate Data Integrity Risk Assessment Tools
Author: Ivan Soto |
Integrating Good Distribution Practice Into The QMS
Author: Tim Sandle |
Managing Knowledge and Risk – A Lit Review on the Interdependency of QRM and KM as ICH Q10 Enablers
Authors: Marting J. Lipa, Keving O’Donnell, and Anne Greene |
The Regulatory Affairs Management In Smart – Working: From The Lockdown Experience To Possible Future Scenarios
Authors: Nadia Esani and Joseph Brennan |
Validation case Studies and Compliance Case Studies – Invitation to Participate
Author: Paul L. Pluta |
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| Vol. 24, Issue 4, Jul 2020 |
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COVID-19 And The Need For Robust Risk Control Strategies – Can ICH-Q9 Help?
Author: Umit Kartoglu, Kevin O’ Donnell and James Vesper |
Facilitating The Lean Laboratory: A Case Study Using The 5 S Approach
Author: Tim Sandle |
Intrinsic Compliance: A Model for Process Validation Optimization
Author: Cliff Campbell |
Investigation of Deviations: Why Are They So Painful?
Author: Ivan Soto |
Regulatory 101: The Basics of New Drug Application Submissions In Major Markets
Authors: Karen R. Zimm and Renee King-Alliego |
Reusable Gowning In Viral Vector Services
Author: Ratul Saha |
Understanding the Concept of Formality In Quality Risk Management
Authors: Kevin O’Donnell, Deidre Tobin, Stephanie Butler, Ghada Haddad, and Donal Kelleher |
IVT Management Roundtable #1: Invitation To Participate – Written, Audio, Visual, And In-Person
Authors: Paul L. Pluta, Stacey L. Bruzzese |
The Benefits Of Utilizing A Spectrum Of IMportance In Industry
Authors: Daniel O’ Regan and Cliff Campbell |
Vol. 24, Issue 3, May 2020
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Application of Wireless Technology in The Pharmaceuticals Sector: Maintaining Data Integrity, Security
Author: Tim Sandle |
Good Distribution Practice for Clinical Trial materials
Author: Andrea Zobel |
Technical Considerations For Demonstrating Reliability Of Emergency -Use injectors: A Review of Draft
Author: Richard Poska |
Regulatory 101: Drug name modifiers – Definition, Categories, Generics, and CAPA
Authors: Natasha A. Barrow, Paul L. Pluta |
Audit Trails And Data Integrity In Pharmaceuticals and Life Sciences
Author: Ivan Soto |
Compounding Facility Cited For Several Aseptic, Microbiology, And Rapid Methods Issues
Author: Jeanne Moldenhauer |
Continuous Culture of CB. Hep-1 Hybridoma Cell In Fifty Days Using A Bioreactor With a Stirring System
Author: Hasel Aragón, et. al, |
Lessons learned During The Coronavirus – COVID-19 Pandemic
Author: Stacey L. Bruzzese |
Consideration of COVID-19 Prevention measures For Those Working in GMP Pharmaceuticals and Healthcare
Author: Tim Sandle |
CQV #9: What, how, and Why of Handwashing
Author: Paul L. Pluta |
The Survival of Coronavirus SARS-CoV-2 On Surfaces and Designing Disinfection Strategies to Eliminate
Author: Tim Sandle |
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Vol. 24, Issue 2, Mar 2020
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EU GMP Annex 1: What The Final Draft Reveals
Author: Tims Sandle |
The Benefits of Contributing to Industry Publications
Author: Paul L. Pluta |
The Long Awaited Revision 2 to EU Annex 1
Author: Jeanne Moldenhauer |
Annex 1 Revisions, Stakeholder Comment Period, And A Review of Changes
Author: Stacey L. Bruzzese |
Selection and Characterization of a Stable Hybridoma Clone for Producing The CBHepBNatural Monoclonal
Authors: Isi Veitia, Reinaldo Blanco, Dany Miranda, Odalys Pérez, Yeleiny MachÃn, Duniesky MartÃnez, et.al., |
Medication Safety: Epinephrine/Adrenaline Problems, Corrections, and Applications
Authors: Karolina Cieslak and Varanya Chaiyaperm |
REGULATORY 101 – Field Alert Reports
Authors: Karen R. Zimm and Renee King-Alliego |
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Vol. 24, Issue 1, Jan 2020
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Pharmaceuticals in the Environment
Authors: Natasa Vukicevic, Aneta Dimitovska, and Jelena Acevska |
A Like-For-Like Change Assessment Tool
Authors: Alma O’Reilly and Donncadh Nagle |
Application of Validation Principles to the Training Quality System. Part 5 – Training Process
Author: Paul L. Pluta |
Ready for the Count? Back-To-Basics Review of Microbial Colony Counting.
Author: Tims Sandle |
Building Effective CGMP Training Designed For the Adult Learner
Authors: Lorianne Richter and Nuala Calnan, Ph.D. |
Regulatory Actions Taken in Response to Issues in Aseptic Processing and The Quality System
Author: Jeanne Moldenhauer |
