Jan 11, 2018 - Jan 12, 2018 | 9:00 AM - 6:00 PM Add to Calendar 11-01-2018 09:00 12-01-2018 18:00 America/Toronto What is Process Validation Report | 21CFR11 Compliance Checklist 2018 Course ...

Noven Pharmaceuticals, maker of the Fentanyl Transdermal System--an opioid patch used for long-term pain treatment--has come under fire by the FDA for poor process validation and for running equipment ...

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

The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the ...

Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This ...

A moldmaker said recently that it sometimes takes him up to eight months to validate a large, high-cavity medical mold. Maybe this surprises you, but it doesn’t surprise many OEMs in the medical and ...