| 2004N-0408 - Regulatory Site Visit Training Program | |||||||||||||||||||||||
| FDA Comment Number : | EC7 | ||||||||||||||||||||||
| Submitter : | Mr. John Coleman | Date & Time: | 10/19/2004 04:10:07 | ||||||||||||||||||||
| Organization : | St. Jude Childrens Research Hospital | ||||||||||||||||||||||
| Drug Industry | |||||||||||||||||||||||
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| Issue Areas/Comments | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| St. Jude Children's Research Hospital (SJCRH) is interested in learning more about this training opportunity of CBER staff. SJCRH operates a registered facility that supports our transplant program and has a 65,000 SF facility for the manufacture of clinical (phase I & II) biologicals (vaccines, therapeutic proteins, and gene therapy products.
If the CBER staff has any interest in visiting SJCRH as part of this Regulatory Site Visit Training Program I can be contacted as follows: John Coleman VP Therapeutics Production & Quality 332 N. Lauderdale St. Memphis, TN 38105-2794 Telephone: 901-495-5301 e-mail john.colman@stjude.org | |||||||||||||||||||||||