Oral Solid Dosage: New Guidance You Can Use Right Now (E03)
Current as of 27 January 2010
This is sponsored by the OSD Community of Practice.
Examine and extract critical perspectives from warning letters and apply the new industry guidance to the benefit of your company. Attend this session covering the key topics of risk assessment, adulteration, compliance-focused processes, as well as other key topics vital for multi-product production and development. This session will feature the entirely new, ISPE Baseline Guide: Volume 2 – Oral Solid Dosage Forms, which has been reviewed by the FDA. Issues identified in warning letters will be used as the basis for problem-solving workshops and discussions with subject matter experts. An FDA speaker has been invited and the two-day seminar will be lead by members of the Guide Writing Team.
Breakout sessions using the new OSD Guide will allow you to discuss solutions to real problems faced in an OSD environment with subject matter experts. An FDA speaker has been invited, and the seminar will be lead by members of the OSD Guide writing team. An OSD Guide copy will be provided as part of seminar registration.
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Understand the importance of the new guide
- Understand how it can help you avoid compliance issues
- Be able to incorporate its elements to improve quality, efficiency and reduce costs
Who Should Attend
Anyone involved in OSD manufacturing and especially those in Generic and Contract Manufacturing since you are currently a focus of FDA and other Global Regulatory agencies
- Jeff Campie, USA
- Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
- Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
- Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
- Edwin Melendez, Principle Consultant, Parexel, USA
- Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
- Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
- Julian Wilkins, Vice President, PharmaConsult US Inc, USA
- Paul Wreglesworth, Independent Consultant, United Kingdom
Communities of Practice (COPs)
Oral Solid Dosage
CPIP™ Knowledge Elements
This Webinar relates to the following CPIP™ Knowledge Elements:
Related Technical Documents, Articles, and Publications
ISPE Baseline Guide®: Volume 2 – Oral Solid Dosage Forms (Second Edition) (Available November 2009)
ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.
Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.