Proactive GCC Quality Compliance Workshop
In pharmaceutical manufacturing, compliance with
GCC regulations, Module 3, needs to be part of a
firm’s business thinking. The underpinnings of GCC
coincide with the aims and goals of international
groups such as PIC/S, which is to ensure quality
of manufactured products and safety of patients
who consume them. Consequently, the quality
requirements and quality assurance requirements
are being harmonized across worldwide regulatory
entities, some of which are GCC, MHRA, USFDA,
EMA, TGA, Brazilian agency ANVISA etc. Since
regulators are playing an increasing role in influencing
the operations of pharmaceutical companies, UBM
has designed this workshop to examine the key local
and global regulatory developments impacting GCC
regulations and their evolution in 2015 and beyond.
Addressed at this workshop are GCC Module 3
topics pertaining to Quality assurance to include
Pharmaceutical Quality Systems Elements (PQSE),
Corrective and Preventive Action (CAPA) and
Computer Systems Validation (CSV). This workshop
is being conducted by an internationally known
Subject Matter Expert (SME) in QA with a proven
track record of implementing over 200 systems and
successfully defending these systems to regulators to
obtain “fit for use” certification.