System Suitability Testing in Chromatographic Compendial Methods

Understanding and Implementing Recent Changes in USP and EP .

January 9, 2008

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with GxPs, Part11, HIPAA, SOX and other regulations.

February 7, 2008

Understanding and Implementing ISO 17025

Requirements, Strategies and and Tool Kits for Laboratory Accreditation

February 14, 2008

Validation of Analytical Methods and Procedures

Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance

February 28, 2008

Understanding USP Documents and Reference Standards

General Chapters, General Notices, Monographs, Forum, Reference Standards

March 13, 2008

Understanding the New USP <1058> for Analytical instrument Qualification

With SOPs, Templates and Examples for Easy Implementation

March 27, 2008

Learnings from Recent FDA Warning Letters Related to Computers  and Part 11

With Clear Recommendations for Corrective and Preventive Actions

April 3, 2007

With master plans, 22 SOPs, Checklists, Examples, Audio seminar

Interpharm Besteller

Reference book for computer validation in laboratories

For FDA/EU Compliance of Excel Spreadsheets

With Video presentations, primer, SOPs, checklists and examples

www.fdawarningletter.com

190 GxP related FDA

EIR's/483's and Warning Letters