GMP operations are evolving as organizations increase reliance on digital systems, risk-based processes, and modern documentation tools. This webcast focuses on the most significant GMP changes impacting teams in 2026—from improved change control workflows to inspection trends and cross-functional readiness. Learn how leading companies are proactively preparing for heightened scrutiny and new process expectations.
Speaker Ken Shitamoto, Member of FDA Industry CSA (FICSA) and GAMP Americas' Steering Committee
Author: Olivia Calder, Process Engineer at Kneat Solutions Contact Information: olivia.calder@kneat.com An audit trail is a chronological record of events and activities, detailing who, what, when, and where actions occurred. According to the FDA guidance, “Data Integrity and Compliance With Drug CGMP – Questions and Answers,” personnel responsible for record review must also review the […]
