If you have trouble viewing this email, click here.
Pharmaceutical Manufacturing and Equipment Risk Management for Pharmaceutical Manufacturing and Equipment: Meeting Regulatory Expectations and Preventing Contamination A free webinar sponsored by ALFA LAVAL Presented by Pharmaceutical Technology January 27, 2011, 11:00AM EST

» TO REGISTER GO TO www.pharmtech.com/risk

Event Overview:
This free, hour-long webinar will provide a clear understanding of the risk-based concepts behind recently adopted guidelines including the International Conference on Harmonization’s Q9 Quality Risk Management document and ISPE’s Risk-MaPP baseline grid. The harmonized guidelines have been adopted and issued as formal guidance documents by regulatory bodies in the US (FDA), Europe, and Japan. Specific concepts, implementation details, and tools will be discussed regarding how to prevent contamination of products, including parenterals, that may be caused by pharmaceutical processing and manufacturing equipment and facility environments.

Featuring
• Dr. Mike Long, MBB
Director, ValSource LLC
Group Leader, PDA Quality Risk Management Interest Group
• Jeffrey Hartman, Validation Manager, MMD Validation Quality Assurance, Merck
Group Leader, PDA Quality Risk Management Interest Group
• Per-Ake Ohlsson, Global Manager, Market Unit Pharma & Personal Care, Alfa Laval Lund AB
• Invited: Expert representatives from the International Conference on Harmonization’s Quality Implementation Working Group
- Moderated by Angie Drakulich, Managing Editor, Pharmaceutical Technology

Key Learning Objectives:
• What regulators in the US, Europe, and Japan expect regarding applying a risk-based approach to manufacturing facilities and equipment, including those for biopharmaceuticals.
• The concepts behind ICH Q9, Risk-MaPP, and the pending ICH Q11 guideline on the development and manufacture of drug substances (e.g., biopharmaceuticals and APIs).
• How to prevent and avoid contamination of your parenteral products using risk-based tools, controls, and analyses.

Who Should Attend:
» Pharmaceutical manufacturing and regulatory professionals involved in formulation, cleaning validation, qualification/commissioning, analytical testing, chemistry, laboratory control, quality assurance/quality control, manufacturing, and any industry professional interested in ensuring product quality by preventing product contamination

For more information please contact Joseph Furrevig
at jfurrevig@advanstar.com or 1-732-346-3057
» TO REGISTER GO TO www.pharmtech.com/risk