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IPEC-Americas Web Based Training - 2011
Five Educational Modules on topics critical to manufacturers and users of pharmaceutical excipients/ingredients!
Sessions are Facilitated by Industry Professionals and will help you develop your skills and advance your career
Discounts offered for participation in all five modules
$275.00 for members of IPEC-Americas Member Companies
$500.00 for Non-members.
$500.00 for Non-members.
Interested in one specific topic? Sign up for one session!
$75 for IPEC-Americas Member Company Employees
$150 for Non-members
Best Value – Sign up for all five sessions and save hundreds!
2011 Schedule! Session Topics to include:
February 15: Significant Change - Dave Schoneker, Director Global Regulatory Affairs, Colorcon
March 15: Certificates of Analysis - John Giannone, Business Development Manager, Cognis Corporation
April 12: Excipient Pedigree - Linda Herzog, Marketing Director, Asahi Kasei America
May 17: Stability - Phil Merrell, Technical Marketing Manager, Jost Chemical Company
June 21: Validation - Ann Van Meter, Senior Quality Systems Specialist, Dow Wolff Celluosics
Beginning 3rd Quarter 2011:
GMP – Part 1
Global regulations - How they are applied to excipients and GMP for excipients
Understand and Review various global guidelines, IPEC GMP, ICHQ7, WHO CMPs & GDPs
Presenter: Maria Guazzaroni Jacobs, Ph.D., Director of Quality and Regulatory Policy, Pfizer, Inc., and Dale Carter, Quality Director- Silica, J.M. Huber, Engineered Materials (invited)
GMP Part 2
Case Studies from Excipient Manufacturers and Users. Don’t make the same mistakes - Avoid 483’s! What to do to fix an issue after an observation?
Presenter: Dale Carter, Global Quality Director- Silica, J.M. Huber, Engineered Materials and Maria Guazzaroni Jacobs, Ph.D., Director of Quality and Regulatory Policy, Pfizer, Inc. (invited)
Quality Agreements
Defining Quality Agreements, General Provisions, and Key Quality Elements
Presenter: Alexa Smith, Regulatory Services Manager, Colorcon (invited)
Auditing
How IPEC Guidance Documents and the Excipient Information Package (EIP) Relate to the Supplier Audit Process
Presenter: Dale Carter, Global Quality Director- Silica, J.M. Huber, Engineered Materials (invited)
Handling an FDA Inspection
Yikes, the FDA is here – Don’t Panic. Understanding FDA Rules, Regulations, and Expectations - Most Common GMP Deficiencies (invited)
Ann Van Meter, Senior Quality Systems Specialist, DowWolff Cellulosics (invited)
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