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…
Tuesday, June 28, 2022 Daily Archives
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…
eBook: Biopharmaceutical Training — Designing Effective Adult-Learning–Based Programs
Biopharmaceutical industry training is imperative not only to ensure patient safety, but also to develop a skilled workforce that can support successful businesses. Current good manufacturing practice (CGMP) skills and behaviors are needed so that products being developed, manufactured, and delivered are compliant and within specifications. Individuals who fulfill roles within development, manufacturing, and delivery processes need some level of education to develop all the necessary skills and behaviors. Adult earners have unique needs and requirements that must be incorporated…
AstraZeneca pumps $69m into Ireland drug substance capabilities
The investment will expand drug substance production capabilities at facilities in Blanchardstown and Athlone run by AstraZeneca subsidiary Alexion. Having acquired Alexion in June 2021 (six months after the $39 billion deal was announced), AstraZeneca pledged last week to expand its manufacturing footprint at its Irish facilities in College Park, Blanchardstown and Monksland Industrial Park, Athlone. The €65 million ($69 million) will be split across three investments, a spokesperson from the firm told this publication, with equipment and warehouse facilities…