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50 New Usersclub Additions

- 18 SOPs
- 12 Examples/Checklists
- 5 Forms/Templates
- 2 Master Plans/Primers
- 3 FDA Presentations
- 10 Warning Letters

 

 

 

FDA/EU Compliant Training for Laboratory Personnel

What to train - How much to Train - How to Document Effectiveness

February 16, 2012

 

Implementing the New USP Chapter <1224> for Analytical Method Transfer

With SOPs, templates and examples for effective implementation

March 15, 2012

 

Quality by Design (QbD) for  Development and Validation of Analytical Methods
Learn how to design robustness for easy transfer and to avoid OOS situations
January 26, 2012

 

Qualification of Virtual Networks and Cloud Computing

With Strategies and Tool Kit for Compliance and System Uptime
February 9, 2012

 

How to get the most out of Supplier Support  for Equipment and Computer Validation

Strategies for suppliers to maximize business and for users to minimize validation cost

Recorded

 

Cost Effective Computer System Validation: Step-by-Step

With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation

Recorded

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with Part 11, PIC/S and Annex 11.

Recorded, available at any time

 

Periodic Review and Evaluation of Computer Systems

With strategies and tools for FDA and EU compliance

Recorded, available at any time

 

Raw Data in FDA Regulated Environments

FDA/EU compliant recording, maintenance and archiving

Recorded, available at any time

 

Transfer of Analytical Procedures According to the New USP Chapter <1224>

With SOPs, templates and examples for easy implementation

Recorded, available at any time

 

Verification of Compendial Methods according to the New USP Chapter <1226>
Understand the new risk based approach and  get real world case studies for testing
Recorded, available at any time

 

Learning from Recent Warning Letters Related to GMP Laboratory Controls

For Preparation of FDA and International GMP Laboratory Inspections

Recorded, available at any time

 

Validation of Bioanalytical Methods and Procedures

Conduct and Document for Efficiency and FDA&EMA Compliance

Recorded, available at any time

 

How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

Learn what the FDA is looking for and how to respond

Recorded, available at any time

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded, available at any time

 

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

250 GxP related FDA

EIR's/483's and Warning Letters

 

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New Macro & Spreadsheet Quality Package
Training for FDA Compliance + Tools for Implementation
Labcompliance.com