Here are some articles I have written since leaving FDA in January 2005. They are, sort of, in chronological order.
The FDA 483-
The FDA 483
GCP Vendor Audits-
GCP_Vendor_Audits_Final_Proof
Bimo Trends 2008
Supervisory Responsibilities of Sponsors-
BNA Article on Supervisory Responsibilites of CIs
Protocol adherence and Records-
Protocol Adherence and Recordkeeping
Notes to File-
ACT_NTF_March_08 Final
Quality Systems for Monitoring -
July 08_Anderson_RAPS Focus_Monitoring
Final Reports0
Investigator Final Reports_Anderson_Aug09
Declaration of Helsinki-
GCPj Final Rule Non IND Trials
DC Freedom