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 (Second Edition).
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).
ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.
Drug Shortages Reveals Progress – First Drop Since 2012
Wednesday, 20 Jul 2016 17.07
Dare to be Different – Pharmaceutical Facilities of the Future
Tuesday, 19 Jul 2016 15.07
Data Integrity and Your E-records Storage Devices
Thursday, 14 Jul 2016 13.07