Quality

PUPSIT: Consideration In Implementation

By Jeff J. Gaerke P.E.

Power of Design Review

By Chip Bennett

How To Understand ASTM E2500

By Robert Chew, PE

Company X Quality Systems Integration

QCR: Operational Readiness

QMS Remediation to Comply With FDA / EU / Industry Best Practices

Qualified Person Guidance on Internal QMS Remediation Plan to Comply With EU GMPs

Regulatory and Quality Consulting, Operational Readiness Services

Equipment Qualification of New Cultured Meat Facility

QC Lab

Optimizing Process Loads for VHP Decontamination – Takeda P3

Alofisel P3 Cell Therapy Facility

SAP S4HANA Implementation

By Connie Leech

Regulatory Support and CTD Writing for Tech Transfer Project

Delving into the FDA’s Guideline: An Overview of CAR T-Cell Product Development and Clinical Protocols

Quality Operations Support