Education Sessions

Hot Topics in Aseptic Processing (305)

29 October 08.15-11.15 Track: Manufacturing Operations

ISPE CEUs: 0.2

agenda(PDF Current as of 9 October 2008)

Continuing technological advances and regulatory changes in aseptic processing requires professionals continually working to stay current. This session will pull some of the best concepts from the two-day Annual Aseptic Processing Symposium recently offered at the ISPE Conference in Tampa. If you did not attend that conference, attend this session for a summary of the best principles presented there.

Topics covered:

  • Annex 1 implementation challenges
  • Trends in the Disposable Technologies
  • Multi-chamber containers for injectible drugs

How You Will Benefit

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

  • Outline key new developments/challenges in aseptic processing
  • Identify trends in process design and current regulatory issues
  • Describe innovative practices and how they can improve efficiencies and plant output

Technical Documents - www.ISPE.org/publications

Sterile Manufacturing Facilities Baseline® Guide

Who Should Attend

Professionals involved in managing, planning, engineering, operation, and qualification of compliant aseptic processes for production of sterile injectible projects

ISPE Communities of Practice (COPs)

Sterile Products Processing (SPP)

 

Session Leader

  • Manmohan Sihra, Director Aseptic Process Design, Bristol-Myers Squibb, USA

Session Speakers

 

Annual Meeting Sponsors