Education Session
505 - Continuous Pharmaceutical Manufacturing
– Opportunities Now and in the Future
11 November 08.15-11.15
ISPE CEUs: 0.25
Tracks: SurvivalProductFacilitiesRegulatoryQualitySupplier
Continuous manufacturing methodologies offer prospects for improving the efficiency of pharmaceutical manufacturing operations while enhancing quality assurance. This session will discuss important scientific and regulatory issues associated with continuous pharmaceutical manufacturing.
Current and future opportunities for continuous manufacturing, including the use of innovative and advanced technologies, will be discussed by industry and academic leaders. Regulatory issues unique to continuous processing will also be discussed.
How you will Benefit
At the end of this session, participants will be able to:
- Understand the value of continuous pharmaceutical manufacturing
- Describe approaches and technologies currently available to implement continuous manufacturing of pharmaceutical products
- Outline future trends and opportunities in continuous manufacturing
- Analyze the quality, validation, and regulatory issues associated with continuous processing
Who Should Attend
Any professional in a quality discipline, scientists and engineers involved in pharmaceutical process development and analysis, technology transfer, validation, CMC regulatory, compliance, manufacturing, quality control, quality assurance, process control, and engineering
ISPE Communities of Practice (COPs)
API, Biotech, C&Q, GAMP, IP, OSD, PAT, PPD, and PM
View the ISPE Community of Practice (COP) Guide
Session Leaders
- Paul D'Eramo, Executive Director, Johnson & Johnson USA
- Elaine Morefield, PhD, Division Director - DPA II, FDA/CDER/ONDQA USA
Session Presenters
- Malcolm Berry, Continuous Chemistry Team Manager, GlaxoSmithKline United Kingdom
- Richard Friedman, Invited, Dir, Mfg & Product Quality, FDA/CDER USA