|This course is not currently scheduled, but may be conducted at your company. Please contact ISPE for more information.|
Using case studies and exercises this course in facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products. The course includes a review of facility design and regulatory issues important in the US and Europe that involve industry trends and changing regulatory policy. Participants will discuss current case studies on a wide array of facility topics, and complete class exercises that involve developing facility scope of work and deliverables to meet corporate economic goals and regulatory requirements.
Immediately apply the course objectives using the complimentary copy of the Biopharmaceutical Manufacturing Facilities Baseline® Guide.
This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.
This training course is of particular interest to existing and future members of the ISPE Biotechnology Community of Practice (COP).
This course contains knowledge related to the CPIP™ technical knowledge competency element Facilities and Equipment: Design and Construction / Installation. For complete information concerning the knowledge elements or the CPIP Credential, please visit 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 sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.