Education Session

609 - Why the New OSD Guide is Vital

11 November 12.45-15.45; Break 14.00-14.30
ISPE CEUs: 0.25

Tracks: Product DevelopmentProduction Systems

Sponsored by the OSD Community of Practice

What you will learn

The new, completely revised ISPE Baseline® Guide: Volume 2 – Oral Solid Dosage Forms, Second Edition, is at the press and will be available at ISPE 2009 Annual Meeting. Attend this session to gain insight on how you can apply this new guidance in addressing risk assessment, adulteration, compliance-focused processes, as well as other key topics vital for multi-product production and development. ISPE’s Baseline® Guides are reviewed by the FDA.

How you will Benefit

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

  • Understand the importance of the new Baseline Guide
  • Understand how it can help you avoid compliance issues
  • Be able to incorporate its elements to improve quality and reduce costs

Who Should Attend

Anyone involved in OSD manufacturing, and especially those in generic and contract manufacturing as they are the risk target of agencies

ISPE Communities of Practice (COPs)

OSD, API, C&Q, CU, ESB, HVAC, IP, Packaging, PPD, PM, and Sustainable Facilities

View the ISPE Community of Practice (COP) Guide

Session Leader

  • Stephen Yu, Managing Director, Bayesian-Consulting LLC USA

Session Presenters

Annual Meeting Sponsors