PharmTech

Using Software in Process Validation

Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction. Within pharmaceutical manufacturing, the goal of process ...
Yahoo Finance

Biopharmaceutical Manufacturing Process Validation: Understand FDA Guidance and EU Guidelines (Nov 17th - Nov 18th, 2025)

Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Biopharmaceutical Manufacturing Process Validation (Nov 17th - Nov 18th, 2025)" training has been added to ResearchAndMarkets.com's offering. This ...
YouTube on MSN

The end of checkbox compliance: Aldo Vidinha on the FDA's quality revolution

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...
PharmTech

Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ Batches

The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ ...

Why Validation In Life Sciences Can No Longer Be A One-Time Event

Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.
Royal Society of Chemistry

Process validation and qualification, including validation methods

This course provides candidates with practical tools for validation including, qualification, process validation and analytical method validation. Incorporating facility/equipment qualification, ...