Product Quality Lifecycle Implementation (PQLI) Global Update

Duration: 2.5 hours
ISPE CEUs: 0.2

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ISPE's Product Quality Lifecycle Implementation (PQLI) program is an industry-driven initiative designed to develop a practical and pragmatic approach to improving industry product realization and manufacturing performance. Focused initially on implementing Q8, Q9, and Q10 ICH guidance documents, PQLI provides the link between these ICH guidelines and the needs of those implementing them.

PQLI helps craft a pragmatic approach to implementing Q8, Q9 and Q10, using a risk-based approach to the lifecycle of a product – from regulatory submission to end-of-life. The PQLI program provides a technical framework for the application of manufacturing sciences throughout the industry, for example illustrating best practice implementation of Quality by Design (QbD) based on sound scientific, engineering, and business principles. Uniquely, PQLI involves worldwide regulators in the development and implementation of this critical thinking.

This recording is a rare opportunity to hear both reviewers' and inspectors' perspectives from all three ICH regions.

How You Will Benefit

At the end of this session, participants will be able to:

• Understand the views of senior regulators from USA, Europe, and Japan
• Help formulate your future by participating in this global initiative
• Understand how design space, criticality, control strategy, legacy products, and biotechnology are integrated
• Provide input into the future development of PQLI

Who Should Attend

This will be of interest to a range of participants from senior leaders to project managers from regulatory, development, quality, and manufacturing who wish to facilitate the future framing of QbD

ISPE Communities of Practice (COPs)

• Active Pharmaceutical Ingredients (API)
• Commissioning and Qualification (C&Q)
• Process Analytical Technology (PAT)
• Project Management (PM)
• Process/Product Development (PPD)

Related Articles

• PQLI Control Strategy Model and Concepts
• PQLI Key Topics - Criticality, Design Space, and Control Strategy
• PQLI Definition of Criticality
• PQLI Design Space
• PQLI Engineering Controls and Automation Strategy
• PQLI Control Strategy Model and Concepts

Session Speakers

• John Berridge, Pharma Quality & Reg., United Kingdom
• Joseph Famulare, Deputy Director, Office of Compliance, CDER, FDA, USA
• Yukio Hiyama, Section Chief, Drugs Div, National Inst. Health Sciences, Japan
• Frank Holcombe, Associate Director for Chemistry, Office of Generic Drugs, OPS, FDA, USA
• Gert Moelgaard, Vice President, Consulting, NNE Pharmaplan, Denmark
• Jacques Morenas, Assistant Director, AFSSAPS, France
• Moheb Nasr, Director, Office of New Drug Quality Assessment, OPS, FDA/CDER/ONDQA, USA
• Christopher Potter, CMC Pharma. Consultant, CMC Pharmaceutical Consultant, United Kingdom
• Jean-Louis Robert, Head of Department, National Health Laboratory, Luxembourg
• David Selby, Managing Director, Selby Hope International Ltd, United Kingdom
• James Spavins, VP, Global CMC, Pfizer, Inc., USA

Continuing Education Units or CEUs are a way to document time spent in educational programs. ISPE CEUs are calculated as follows: 1 CEU = 10 hours of education time. Thus 0.1 CEU is equal to one hour of education. Download a form to apply for the CEUs for this program.