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Part 11 Package now With Video Seminar

- 15 SOPs
- Master Plan
- 8 Examples
- 3 Checklists
- 2 Reference Papers

 

 

Understanding and Implementing the New EU Annex 11

Learn about specific requirements and get tools for implementation

May 8, 2008

 

Selection and Use of (Certified) Reference Material

Strategies for  FDA/ISO 17025 Compliance and Tools for Implementation
Recorded

 

Sampling and Sample Handling in Laboratories
Strategies for  FDA and ISO 17025 Compliance and Tools for Implementation (195)
May 20, 2008

 

Development and Validation of Stability Indicating Methods
Planning - Design - Conduct - Documentation
May 29, 2008

 

Contingency and Disaster Recovery Planning for Computer Systems (197)
To Ensure Business Continuity and Compliance
June 12, 2008

 

Writing Effective SOPs For Regulatory Compliance
Content, format, approval, training and distribution.
June 26, 2008

 

Understanding the New USP <1058> for Analytical instrument Qualification

With SOPs, Templates and Examples for Easy Implementation

Recorded

 

Learning from Recent FDA Warning Letters Related to Computer System Validation and Part 11
With Clear Recommendations for Corrective and Preventive Actions
Recorded

 

For CD for training and tools for easy implementation

 

 

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

 

  

 


 

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190 GxP related FDA

EIR's/483's and Warning Letters

 

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