Author Archives: IVT Network

IVT Network Podcast Archive

Journal of Validation Technology 2022  The EU GMP Annex1 Revision 2022 Implementation Laboratory Review Process and Its Impact on Compliance Data Integrity and Integrating Automation Risk Revolution: ICH Q9 Revision, Is it Enough? The Quality Control Response to COVID Disruption in Labs  The New Norm for Life Sciences Talent Evolution 2021 Paper Versus Electronic Records Ruggedness of Visible Residue Limits for Cleaning Validation Cognitive Biases in Strategy and Execution Fuzzy Logic, Risk Management, and Critical Thinking in Pharmaceuticals.  Integrate Risk…

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…

IVT Journal Archive

IVT Network Archive The Journal of Validation Technology, The Journal of GXP Compliance, and the IVT Network have served proudly for nearly 30 years as a global knowledge base for validation and compliance professionals in FDA-regulated industries. To make peer-reviewed validation resources available to the broader biomanufacturing community, the IVT Network is joining sister publication BioProcess International. Starting in July 2022, articles from the past two years of JVT and GXP can be accessed here on the BioProcess International website.…

IVT – GXP Journal Archive

Journal of GXP Compliance Archive Vol. 26, Issue 2, Mar 2022 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…