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Training |
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Biopharmaceutical Manufacturing Facilities (Includes Webinar)
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Date |
Location |
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Instructor(s) |
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| 25-26 Feb 2008 | ISPE Conference on Manufacturing Excellence Tampa, FL |
United States | Jeff Odum | |||
| 24-25 Sep 2008 | New Jersey Classroom Training Series Someret, NJ |
United States | Jeff Odum | |||
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17-18 Nov 2008 |
San Diego Classroom Training Series San Diego, CA |
United States | Jeff Odum | |||
Description
Improve your working knowledge of biotechnology manufacturing facility design concepts used in the development of sound designs for facilities that manufacture biopharmaceutical products. Case study discussions focus on a wide array of facility topics, and class exercises involve the development of facility scope of work and deliverables to review facility design and regulatory issues important in the
U.S. and Europe that involve industry trends and changing regulatory policy. Learn to use the Biopharmaceutical Manufacturing Facilities Baseline Guide as a primary reference tool.
Complimentary copy of the Biopharmaceutical Manufacturing Facilities Baseline® Guide provided.
Take Back to Your Job
- Knowledge of the impact of critical utilities on facility design; terminology; current industry trends in facility design and construction; and facility design concepts related to current Good Manufacturing Practices (cGMPs)
- Tips on how to apply engineering design principles related to biotechnology product manufacturing
- An understanding of biotechnology process attributes tied to equipment and facility design
- Details on the regulatory review process and current industry guidance documents for facility design
- The latest on project economics for facility design
Who Should Attend
Individuals who want to improve their working knowledge of biotechnology manufacturing facility design concepts; professionals who need a focused understanding of the issues a biotechnology manufacturing company must address in order to develop a facility design that meets current regulatory requirements and corporate economic goals; and individuals who provide services and/or assistance to biotechnology manufacturing companies to design, construct, validate, and finance facilities
Communities of Practice (COPs)
Biotechnology
Related Technical Documents
Biopharmaceutical Manufacturing Facilities Baseline Guide
Important Course Notes
- Includes On-line Essentials, a pre-recorded, Web-based session providing a review of basics prior to the classroom course
- Course contains information related to the Certified Pharmaceutical Industry ProfessionalSM ( CPIPSM ) technical knowledge competency element of Facilities and Equipment - www.ISPE-PCC.org
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 mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.
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