Agilent | Archive Compliance News

Archive of Compliance News
Dr. Ludwig Huber, Compliance and Validation Expert

November 2008
FDA Release Draft Guidance for Residual Solvent Analysis USP <467>
May/June 2008
Impurity Profiling in Pharma
March/April 2008
Validated Chromatographic Methods: Change versus Adjustment
January/February 2008
Method Transfer from Standard to Rapid Resolution LC
December 2007
Genotoxic Impurities in Focus of Regulations
November 2007
New GAMP Guide on Electronic Data Archiving
October 2007
Increased FDA Enforcement of Electronic Record Compliance
September 2007
Update on FDA’s 21 CFR Part 11
August 2007
New edition of "Rapid Resolution LC Compendium CD"
July 2007
USP <467>: Residual Solvents - Delayed to July 2008
June 2007
FDA Releases Final Guidance on Using Computerized Systems for Clinical Trials
May 2007
Video Webcast: How USP Chapter <1058> on Analytical Instrument Qualification Will Effect You
April 2007
Transferring Standard HPLC Methods to the Agilent 1200 Series Rapid Resolution LC System
March 2007
New USP Chapter <467> Residual Solvents Coming into Effect July 1, 2007
Jan/Feb 2007
FDA USP Chapter <1058> on Analytical Instrument Qualification Close to Final
December 2006
FDA Releases Final Guidance on Quality Systems to Pharmaceutical CGMP Regulations
November 2006
FDA Releases Final Guidance on Handling OOS Test Results
October 2006
Free- New Routine Pharmaceutical Analysis Compendium CD
September 2006
Using GC/MS in FDA Regulated Environments
July/August 2006
Risk Based Validation of Commerical Off-the-Shelf Computer Systems
June 2006
US FDA Intends to Join PIC/S
May 2006
GAMP Good Practices Guide for Validation of Laboratory Computer Systems
April 2006
An Inspector's Perspective on Computerized Systems Validation
March 2006
Update on FDA's 21 CFR Part 11
February 2006
New USP Draft Chapter <1058> The 4Q Model for Equipment Qualification is Becoming Official