Implementing GEP (Good Engineering Practices) in the Pharmaceutical, Bio-Pharmaceutical, and Medical Training Course :

<strong>Course Schedule - March 24, 2009 at 11:00 a.m. - 12:30 p.m. (EST) </strong><br/><br/>This 90-minute<b><i> accredited</b></i> online course is aligned with current industry “Risk-Based” initiatives and guidance provided in ICH Q9, ASTM E2500, and ISPE Baseline & Good Practice Guides. This course will provide insight on critical project decision making and enable a project team to identify and document data during the application of GEPs during the design, specification, and verification phases of a project. Discussions will focus on identifying and implementing Engineering Quality Systems to assure efficiency and quality.<br><br> <b><u>Module 1:</u></b><br>   • GEP Overview<br>   • Engineering Quality Systems<br>   • GMP and GEP<br><br> <b><u>Module 2:</u> </b><br>   • Design Review Process<br>   • Change Management<br>   • Risk Management<br><br> <b><u>Module 3:</u> </b><br>   • Applying GEP to the Verification (Commissioning <br>     & Qualification)<br>   • Integrating the Project and Engineering Lifecycles<br>   • Planning for Success<br><br> <b>Question and Answer Session</b>