F
OOD AND
D
RUG
A
DMINISTRATION
O
FFICE OF
R
EGULATORY
A
FFAIRS
Office of Regulatory Science
Document Number:
ORA.007
Revision #: 02
Revised:
25 Aug 2020
Title:
Pharmaceutical Microbiology Manual
Page 3 of 92
For the most current and official copy, check QMiS.
U.S. FDA, Office of Regulatory Affairs
Office of Regulatory Science
Office of Medical Products and Specialty Laboratory Operations
3. Current Editorial Board
Editor-In-Chief: Angele Smith, ORS Headquarters
Rick Friedman, Center for Drug Evaluation and Research
Jennifer Gogley, Pacific Southwest Medical Products Laboratory
Kristy Ford, Detroit Medical Products Laboratory
Marilyn Khanna, ORS Headquarters
Mivoyel Jeanpaul, ORS Headquarters
Sammie La, Pacific Southwest Medical Products Laboratory
Matthew Silverman, Winchester Engineering and Analytical Center
Marla Stevens-Riley, Center for Drug Evaluation and Research
Allison Rodriguez, Winchester Engineering and Analytical Center
Radhakrishna Tirumalai, United States Pharmacopeia
Theresa To, Winchester Engineering and Analytical Center
4. Original Authors
Rhonda Alexander, Southeast Food and Feed Laboratory
Jasna Braut-Taormina, Northeast Medical Products Laboratory
Jennifer Brzezinski, Forensic Chemistry Center
Marie B. Buen-Bigornia, Denver Food and Feed Laboratory
Rick Friedman, Center for Drug Evaluation and Research
Jennifer Gogley, Pacific Southwest Medical Products Laboratory
Andrew Gonzales, Denver Food and Feed Laboratory
Dennis Guilfoyle (ret), Northeast Medical Products Laboratory
Lawrence James (ret), Northeast Food and Feed Laboratory
Marilyn Khanna, ORS Headquarters
David Lau, San Francisco Food and Feed Laboratory
Eileen Liu, San Francisco Food and Feed Laboratory
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