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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdInspections (general)
The following articles on this topic have been published in
CRAdvisor (CRA) – the year, issue number
and starting page number for each are listed below:
Back to index |
| 2007 |
|
| CRA 2007; 187:4 |
BARQA to pilot a GCP inspection database. |
| CRA 2007; 190:4 |
How to avoid inspection problems with the product
specification file. |
| |
|
| 2006 |
|
|
CRA 2006; 169:7 |
Draft pharmacovigilance guideline on monitoring of compliance with
obligations and inspections. |
|
CRA 2006; 170:7 |
GCP inspections symposium. |
|
CRA 2006; 181:1 |
Inspection findings to go on certificates. |
| |
|
| 2005 |
|
| CRA 2005; 149:1 |
European Commission Directive on GCP 2005/28/EC now
published. |
| CRA 2005; 151:7 |
Argentina's new site inspections regulation. |
| |
|
| 2004 |
|
| CRA 2004; 142:5 |
ICH inspection procedures. |
| |
|
| 2003 |
|
| CRA 2003; 110:5 |
Why not conduct more mock inspections? |
| CRA 2003; 121:4 |
MHRA conducts survey to aid inspections. |
| |
|
| 2002 |
|
| CRA 2002; 88:1 |
Inspections by sampling. |
| CRA 2002; 92:5 |
Procedures for the verification of GCP compliance. |
| CRA 2002; 93:5 |
Preparing for regulatory inspection. |
| CRA 2002; 93:8 |
MCA not to inspect Ethics Committees. |
| CRA 2002; 97:7 |
Three documents with the same reference number! |
| |
|
| 2000 |
|
| CRA 2000; 54:4 |
‘Living archive’ may solve access problems. |
| CRA 2000; 57:1 |
EU trials comparable to those in USA! |
| CRA 2000; 57:3 |
Inside inspections: fact about by EU, Japanese and FDA
inspections. |
| |
|
| 1999 |
|
| CRA 1999; 24:8 |
Inspection reports to be better controlled. |
| CRA 1999; 26:3 |
Check your training records. |
| CRA 1999; 30:2 |
Compliance with GCP. |
| CRA 1999; 33:1 |
Electronic data subject to greater scrutiny. |
| |
|
| 1998 |
|
| CRA 1998; 3:5 |
Systems inspection versus focus on data. |
| CRA 1998; 7:2 |
Computer validation becomes target for inspections. |