SOLICITATION NOTICE
U -- Training Development
- Notice Date
- 8/1/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-1020853gh
- Response Due
- 8/7/2006
- Archive Date
- 8/22/2006
- Description
- The Food and Drug Administration intends to procure on a sole source basis professional services from Duquesne University, 600 Forbes Ave., Pittsburgh, PA 15282 for a course on Fundamentals of Pharmaceutical Manufacturing. The purpose of this training is to revisit the fundamentals of, and discuss latest technical developments in the common unit operations and their implementation in the production of solid oral dosage forms for the Agency?s review staff. The composite course should be designed to provide the student with a basic understanding of primarily the practical aspects of pharmaceutical manufacturing and, as appropriate, the theoretical aspects. The student is identified as a chemist (and not an engineer) with a need to obtain greater insights into pharmaceutical manufacturing process. The scope of this course should be limited to eh unit operations leading to compressed, film-coated tablets in the following 7 module sequence: (1) blending, (2) milling, (3) wet granulation, (4) dry granulation, (5) drying, (6) tablet compression, and (7) coating. The course should emphasize: (1) Basic principles of each operation; (2) Current best practices for selecting equipment, selecting operating parameters; and identifying the potential problems with each operation; and (3) Case study illustrating a real industrial project showing both successes and problems. Period of Performance: October 1, 2006 to September 30, 2007. Course development and implementation is anticipated during the first six months with eight half-day module offerings. The location is to be determined, but will be in Maryland. This acquisition will be conducted under simplified acquisition procedures. The NAICS code classification is 541690. This notice is not a request for proposals and no solicitation documents exists for this requirement. However, publishers interested in responding to this notice will need to submit technical data, including cost, sufficient to determine capability in providing the same products and services. All capability statements received by 2:00 p.m., EST, August 7, 2006 will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Inquiries must be submitted in writing by facsimile on (301) 827-7106 or email. No telephone inquiries will be accepted.
- Record
- SN01102828-W 20060803/060801220320 (fbodaily.com)
- Source
-
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