The Future State of Computer Validation, Part I

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-07-02-2001
Volume 25
Issue 7

Current events and trends in regulations, business practices, and technology forecast the future of computer validation.

External Link - article-22755.pdf

Articles in this issue
Musings on the Past 25 Years
Reflections on Changes at FDA
Deliver the Dose
Middle-European Pharmaceutics in a Changing World
The BCS: Where Do We Go From Here?
The Role of USP in the Assessment of Microbiological Quality of Pharmaceuticals
From Inactive Ingredients to Pharmaceutical Excipients
Am I Going Backwards?
The Filter Scene: Old and New
Catching Up with Expert Systems
25 Years of Change in the Parenteral Technology Field
The Future State of Computer Validation, Part I
Statistical Thinking
2001: An Odyssey in Inhaler Formulation and Design
What Is the "Correct" Method to Use for Particle-Size Determination?
Recent Videos
Jens Schmidt, associate director MSAT at Lonza
Christian Dunne, director of Global Corporate Business Development at ChargePoint Technology
Related Content
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

EMA Prepared for Health Technology Assessment Regulation Implementation

Susan Haigney
January 10th 2025
Article

The HTAR, which aims to increase access to new medicines, becomes effective Jan. 12, 2025.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

J&J Gets FDA Fast Track Designation for Alzheimer’s mAb, Posdinemab

Feliza Mirasol
January 9th 2025
Article

Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease.

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

FDA Releases Draft Guidance on Sampling and Testing of In-Process Materials and Drug Products

Susan Haigney
January 3rd 2025
Article

The draft guidance document provides recommendations for complying with 21 CFR 211.110.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

FDA Announces Reopening of Comment Period Regarding HCP Immunogenicity Risk from Follow-on Recombinant Peptides

Feliza Mirasol
January 3rd 2025
Article

The comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, has been reopened by FDA until March 3, 2025.