Education Session

406 - Product Quality Lifecycle Implementation (PQLI®): Focusing on Q10

Get Agenda 10 November 14.15-17.15
ISPE CEUs: 0.25


Tracks: Regulatory

Topics that are new to PQLI will be introduced as the project expands to understand how the ICH Quality Vision can be implemented globally. Challenges that companies face introducing or adapting change management and knowledge management in a pharmaceutical quality system will be discussed from the viewpoint of both industry and regulators whether or not an 'enhanced,' quality by design approach is used. Regulators from FDA, EU and Japan will be invited to provide their findings reviewing applications and inspecting companies. Leading industry speakers will be asked to summarize their experiences. Opportunities will be given for participants to interact with regulators and industry colleagues.

Topics to be discussed will be:

  • Change management
  • Knowledge management
  • Risk management in the manufacturing environment

Progress of existing topics relating to QbD roadmap, quality attributes/critical process parameters, design space, control strategy and QbD for existing products will be illustrated with examples of practical implementation.

How you will Benefit

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

  • Contribute to the latest thinking on implementation of ICH Quality Vision and FDA's Quality Initiative
  • Describe the latest global developments
  • Contribute to PQLI's new activities
  • Understand practical examples of implementation
  • Better understand the perspectives of compliance regulations

Who Should Attend

Any professional in a quality discipline. Don't be shy, there will something for scientists involved in chemical process development and analysis, formulation and packaging development and analysis, CMC project management, technology transfer, validation, CMC regulatory, compliance, manufacturing, quality control, quality assurance, process control, engineering, biotech process development and analysis. Have we missed a CMC professional. It could be you?

ISPE Communities of Practice (COPs)

API, Biotech, GCLP, IP, Packaging, PAT, PPD, PM, and SPP

View the ISPE Community of Practice (COP) Guide

Session Leader

  • David Selby, PhD, Managing Director, Selby Hope International Ltd United Kingdom

Session Presenters

  • Georges France, VP Quality Strategy, Pfizer United Kingdom
  • Shuntarou Fujioka, Ministry of Health, Labour and Welfare (MHLW) Japan
  • Tara Gooen, LT, PHS, Compliance Officer, FDA/CDER/DMPQ USA
  • Jacques Morenas, Assistant Director, AFSSAPS France

Annual Meeting Sponsors