The Office of Regulatory Affairs (ORA), an Office of the U.S. Food and Drug Administration (FDA), coordinates domestic and foreign inspectional, quality and investigational activities across the field and at headquarters. In addition, ORA works closely with the Center for Drug Evaluation & Research (CDER) and the Center for Veterinary Medicine (CVM) on compliance and enforcement activities and to implement policies related to the Pharmaceutical program.

The Office of Training, Education, and Development (OTED), within ORA, trains field and headquarter investigators and analysts to conduct inspections of biopharmaceutical and pharmaceutical manufacturing processes and practices for compliance with good manufacturing practices (GMP) regulations. The trainees for the Biomanufacturing Principles and Processes Curriculum will typically have 5 or more years of agency experience and hold a Bachelor of Science degree. Some will have a background in chemistry, biochemistry, microbiology or engineering.

OTED worked with an outside vendor to create a set of courses to provide investigators additional biological therapeutic drug training with the objective of exposing course participants to:

• Product
• Product development
• Facility and equipment design
• Technology transfer
• Manufacturing processes
• Analytical testing methods

The four (4) courses developed for this series are:

• Quality Control/Analytical Testing
• Upstream Bioprocessing
• Downstream Bioprocessing
• Aseptic Processing

Students must complete all four (4) courses within 12 months. The courses included web-based, classroom, and hands-on training.

Each course allowed for a maximum enrollment of 15 students, took place over a five-week period, and required 32 contact hours. A total of eight contact hours were provided via online instruction over the first four weeks of the course. The remaining 24 hours of instructional time took place over three days onsite at the contractor’s facility in the fifth and final week of the course.

Objective

OTED is interested in working with an institution that does not create/produce products that are or will be regulated by the FDA and/or marketed or introduced to the market and thus regulated by FDA.  The objective of this project is for a contractor to deliver the four-course training curriculum, developed under a different contract by a different source, to Food and Drug Administration (FDA) investigators.  The curriculum is designed to give investigators a greater understanding of biomanufacturing principles and processes, to include facility equipment design, product manufacturing processes, and analytical testing methods.

The curriculum shall be delivered via distance learning technologies, classroom instruction coupled with practical experience in the vendor’s facilities. Multiple contracts may be awarded and students will complete the entire 4 course series from an individua l contractor.[MA1] 

Scope

The contractor shall deliver curriculums via distance learning, followed by classroom instruction, coupled with practical experience. Course delivery shall consist of asynchronous web-based, synchronous web-based, synchronous classroom and laboratory training and the development of comprehensive instructor and participant guides to go with the delivery of the synchronous classroom and laboratory training with respect to the manufacture of biological l therapeutic drugs.  ORA employees will have access to the web from their desktop.  ORA employees will travel to the vendor’s facilities for the on-site portion of the training.