The U.S. Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA) coordinates domestic and foreign inspectional, quality and investigational activities across the field and at headquarters.  In addition, ORA works closely with other FDA Offices 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 five (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 has created a four-course curriculum series to provide investigators with additional biological therapeutic drug training in the following areas:

o Product

o Product development and manufacturing process

o Facility and equipment design

o Technology transfer

o Manufacturing processes

o Analytical Testing Methods

The four (4) course developed for this series were:

o Quality Control/Analytical Testing

o Upstream Bioprocessing

o Downstream Bioprocessing

o Asseptic Processing

OTED requires one individual contractor to deliver the existing four-course training curriculum including course material, modules, and webinars, as necessary, to FDA investigators.  This will allow FDA inspectors to experience the production of biological therapeutic drug products thereby enabling them to better understand biomanufacturing principles and processes to include facility equipment design, product manufacturing processes, and analytical testing methods and to provide them with the skills and knowledge to determine areas of highest risk.

OTED seeks a contractor/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 Contractor shall deliver curricula via distance learning, followed by classroom instruction, coupled with practical experience in the Contractor's facility.  Course delivery shall consist of asynchronous web-based, synchronous web-based, synchronous classroom and hands-on/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 therapeutic drugs.  ORA employees will have access to the web from their desktop.  ORA employees will travel to the Contractor's facility for the on-site portion of the training.  Students must complete all four courses within 12 months.

The Contractor shall perform each of the following tasks within the parameters outlined in this section.  The scope of work details the overall requirements for delivering the biomanufacturing principles and processes curriculum and developing the accompanying instructor and participant guides for that curriculum.  The instructional areas to be covered in the four courses include, but are not limited to:

o Quality Control

o Analytical Testing

o Upstream Bioprocessing

o Downstream Bioprocessing

o Aseptic Processing