|
|
|
Negotiating the Regulatory Minefield for Multi-product Facilities:
Helping CMOs and Generic Manufacturers Avoid Warning Letters, Recalls and Worse
Webinar broadcast live at two times on 24 February: 08.00 EST and 11.00 EST
Duration: 90 Minutes, Level: Intermediate
Online Registration Led by Steven Ostrove, PhD, President, Ostrove Associates, Inc. (Industry Representative for the FDA’s Allergenic Products Advisory Committee from 2005 to 2007), and Julian Wilkins, Vice President, PharmaConsult US Inc., this live webinar identifies elements that should be in a specialized plan for securing regulatory approval in a multi-product facility, provides understanding for all processes involved and how to effectively manage risk and change control in this specialized environment.
It also examines common risks, suggests concrete methods for approaching risk management in a logical and defensible manner, and helps you understand the most frequent areas of regulatory concern, and how to respond to a warning letter. There is real benefit in conducting informal pre-approval discussions.
Registrants will be able to submit questions ahead of time; submit questions to cgarcia@ispe.org. Attendance Recommended For
Professionals from quality, regulatory, validation, operational management, and engineering.
ISPE Online Learning
Live webinars are one of the many new Online Learning programs ISPE continues to add to its family of educational products. Web-based products include: live and recorded Webinars on critical industry and regulatory developments, recorded GMP online courses, Certified Pharmaceutical Industry ProfessionalTM (CPIPTM) online courses, podcasts, live speaker webcasts from ISPE conferences, and post-event video recordings from ISPE conferences. More Information
Targeted advertising and sponsorship opportunities available for ISPE Live Webinars. Contact Dave Hall at tel: +1-813-739-2274, or Valerie Adams, tel: +1-813-960-2105, Ext. 212. | |
| |
No comments:
Post a Comment