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Biopharmaceutical Manufacturing Facilities
Biopharmaceutical Manufacturing Facilities
Biopharmaceutical Manufacturing Facilities
This course provides a review of the concepts utilized in the development of sound designs for facilities that manufacture biopharmaceutical products. It also covers key concepts, processes and strategies required for facility design covered in the Biopharmaceutical Manufacturing Facilities baseline guide.

Learning Objectives

  • Define the key concepts covered in the guide.
  • Identify the key concepts, processes, and strategies required for facility design.
  • Identify additional references within the Baseline Guide
Attendance Suggested for:

  • 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.
  • Individuals who provide services and/or assistance to biotechnology manufacturing companies to design, construct, validate, and finance facilities

Instructor Biography

Jeffery Odum offers more than 25 years management experience in the design, construction, and commissioning of the facilities in the process, biotechnology, pharmaceutical, and chemical industries. Throughout his career, he has been involved in managing conceptual design, detailed design, preconstruction, construction, start-up and validation support for projects ranging in sizes from $1 million to more than $2 billion. Mr. Odum conducts facility compliance and quality systems audits and has participated in the development and presentation of licensing packages to the US FDA. He has provided cGMP audit services and training to Fortune 500 global biopharmaceutical companies, focusing on FDA and EU compliance as part of inspection readiness for the FDA and other global regulators. Mr. Odum has over 50 articles on the subjects related to GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities.
Discounted member price: 99.00
149.00
You could save 33.6%

This course provides a review of the concepts utilized in the development of sound designs for facilities that manufacture biopharmaceutical products. It also covers key concepts, processes and strategies required for facility design covered in the Biopharmaceutical Manufacturing Facilities baseline guide.

 

This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.

Approximate Course Duration: 60 minutes (this is a self-paced course)

*NOTE* You will have 5 calendar days to access and complete this course from time of purchase.

ISPE CEUs: .10 ISPE CEUs will be awarded upon successful completion of grading requirements

 
 

Member Price: $ 99.00 / € 70.00
Non Member Price: $ 149.00 / € 110.00
Item #: WEBCPIPMFUS