Royal Society of Chemistry

New Process Validation Life-Cycle Approach - Apply statistical tools to demonstrate Process Capability - Webinar By GlobalCompliancePanel

This webinar will describe the new Process Validation Life-Cycle Approach as defined in the revised FDA guideline. The three stages will be described in detail including: Process Design, Process ...

Validfor Launches Agentic Digital Validation Platform Delivering Four-Week Go-Lives for Pharma

Validfor is excited to announce the launch of its Agentic Digital Validation Platform for life sciences, designed to ...
Yahoo Finance

ValGenesis Launches Smart GxP™ as First AI-Enabled Platform to Unify Validation and Process Development

ValGenesis Smart GxP™ is the first AI-enabled platform purpose-built to unify validation and process development across the product lifecycle. Featuring five integrated applications—ValGenesis iCMC™, ...
PharmTech

Continued Process Verification Is Critical in Pharmaceutical Manufacturing

Pharmaceutical manufacturing requires defining quality target product profiles and critical quality attributes (CQAs) to ensure desired product quality. Process development identifies critical process ...
News Medical

The Role of Process Validation in Ensuring Consistent Drug Quality

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
Pharmabiz

EMA revises process validation guidelines, insists on data in dossier submission

European Medicines Agency (EMA) which has been following the US FDA guidelines on Process validation so long, has now revised the process validation norms. The revision incorporates the principles of ...
FierceBiotech

Process Validation: A Critical Step in a Biopharmaceutical Product’s Lifecycle

Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...
Business Wire

ValGenesis Acquires 4Tune Engineering, Extends Product Portfolio with Best-in-Class Risk Management and Continuous Process Verification Software Platforms

SAN FRANCISCO--(BUSINESS WIRE)--ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems (VLMS), has acquired Portugal-based 4Tune Engineering (4TE), a leader in ...
Royal Society of Chemistry

Lifecycle Approach to Analytical Methods for Drug Products

This highly interactive course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including elements aligned with QbD concepts. Some of the ...
Business Insider

Icelandic Biotech Firm Selects ValGenesis's Cloud-Based Electronic Validation Lifecycle Management System For a Paperless Validation Process

SAN FRANCISCO, Nov. 26, 2019 /PRNewswire/ -- ValGenesis, Inc., a market leader in Validation Lifecycle Management Systems (VLMS), announced today that an Iceland-based biotech firm has selected ...
Business Wire

Process Validation Guidance Requirements: FDA and EU Annex 15: Qualifications and Validation - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation): 2-Day Workshop "conference has been added to ResearchAndMarkets.com's ...