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Online Audio Seminars come with 10+ Best Practice guides for easy implementation

 

Learning from Recent Warning Letters Related to Good Laboratory Practices

For Preparation of FDA and International GLP Inspections

February 3, 2011

 

Understanding and Implementing the New EU Annex 11

Learn about specific requirements and get tools for implementation

February 17, 2011

 

Development and Validation of Stability Indicating Methods for FDA/ICH Compliance

Sample generation - method development - validation - documentation

Recorded

 

 

Development and Validation of Stability Indicating Methods for FDA/ICH Compliance

Sample generation - method development - validation - documentation

Recorded

 

Validation of Excel® Spreadsheets for Regulated Environments: Step-by-Step

With Case Studies and Validation Protocols for Easy Implementation.

Recorded

 

How to Prepare Yourself for FDA's New Part 11 Inspection Program

Learn what the FDA is looking for and how to respond

Recorded

 

FDA Compliant Use of (Certified) Reference Material

With 10+ Best Practices for easy Implementation

Recorded

 

Effective HPLC Method Development and Validation

Preparation, conduct and documentation for FDA/EMA Compliance

Recorded

 

Recent Warning Letters and 483's Related to Computer Validation and Part 11

With Case Studies to Avoid and Respond to 483's and Warning Letters

Recorded

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded

 

New  release
with 46 SOPs

 

CD for training and tools for easy implementation

 

 

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

 

Comply with FDA's Current Interpretation

Reference book for
Part 11 Implementation

 

For FDA/EU Compliance of Excel Spreadsheets

With seminar presentations, primer, SOPs, checklists and examples

 


 

www.fdawarningletter.com

240 GxP related FDA

EIR's/483's and Warning Letters

 

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