A23. Recent developments in ICH Q series guidances and Quality Manturity
Tracks
GMP/Manufacturing
Wednesday, June 12, 2024 |
4:30 PM - 5:30 PM |
C3.2 |
Chair & Speakers
Abdul Fneiche
Vice President
ISPE Australasia
Chair: Recent developments in ICH Q series guidances and Quality Manturity
Biography
Abdul is a broadly experienced leader in the high-risk pharmaceutical manufacturing space. With a background in compliance, quality, operational management, and change management, he currently serves as Process Performance Lead at ANSTO. Throughout his career, Abdul has spearheaded key initiatives, including capacity expansions, new production lines, and facility establishment.
With a passion for advancing pharmaceutical knowledge and driving the adoption of innovative technologies, Abdul is also the Vice-President of the ISPE Australasia Affiliate.
Abdul has a special interest in high-complexity, and high-risk manufacturing operations.
Maurice Parlane
Dpartner/director
Cbe Pty Ltd
Understanding & implementing Quality by Design, Quality Risk management, and quality maturity models
Biography
Maurice Parlane has 30 years of industry experience in development, transfer, scale up and manufacture of pharmaceutical products. He is a chartered professional engineer with a degree in manufacturing and industrial technology.
Maurice is an ISPE International instructor for ICH related topics and the Advancing Pharmaceutical Quality (APQ) program. He serves on a number of ISPE technical interest groups, is a regular conference and workshop presenter and has contributed to a number of current ISPE publications and good practice guides.
He is a partner in CBE Pty Ltd, Australia and the Principal of New Wayz Consulting Ltd in NZ; and previously held technical roles within the GSK group.
Maurice specialises in guiding clients to develop, improve and manage the quality of new or existing products through application of operational excellence and quality by design principles