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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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 |
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Animal-Derived Ingredients, FDA, and RegulationsAuthors: Karen R. Zimm, Renee Phillips | Application of Validation Principles to the Training Quality System Part 8 – Training Process DocumentationAuthor: 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 |
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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 TestAuthor: 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 BLOGAuthor: Tim Sandle |
Critical Thinking #2: Reading Research Papers – IVT BLOG Author: Tim Sandle | Critical Thinking #3: Developing Questions to Achieve the Optimal Outcome – IVT BLOGAuthor: Tim Sandle | CRISPR Therapeutics: New Emerging Developments and Clinical Applications – IVT BLOGAuthor: Kaiser Jay Aziz |
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E-Records Integrity – Data Warehouse And Data Mart LayerAuthor: 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 |
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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 |
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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 StrategiesAuthors: 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 |
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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 LombardiAuthor: 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 ControlAuthor: 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 |
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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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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 Machín, Duniesky Martínez, 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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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 |
