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Best Practices - Validation and Compliance Books/CD's

All authored by Dr. Ludwig Huber

All Best Practices have been developed based on the author's 20+ years industry experience with FDA and international compliance.

 

  ISO  17025 Accreditation Package
For Fast and Trouble Free Laboratory Accreditation
Understand the ISO 17025 quality standard for testing and calibration laboratories. The package is also ideal to understand and implement modern quality systems as required by FDA for GLP/GCP/GMP. The package comes with an audio seminar, a quality manual, SOPs and checklists.  
More information and ordering.
  Laboratory Compliance Package
With 45 SOPs and interactive audio presentation
Get all essential information you need to understand FDA and international requirements and to develop smart strategies for cost effective laboratory compliance.
Comes with master plan, SOPs, checklists and validation examples for easy implementation.
Includes two years on-line updates.
More information and ordering.
  Computer System Validation Package
With 35 SOPs and two interactive audio presentations
Get all essential information you need to understand FDA and international requirements and to develop smart strategies for cost effective Computer validation.
Comes with master plan, SOPs, checklists and validation examples for easy implementation.
Includes two years on-line updates.
More information and ordering.
  21 CFR Part 11 Compliance Package
Comply with FDA's new directions for Part 11
Learn the basics and FDA's new directions of 21 CFR Part 11. The package helps to develop strategies for most cost effective compliance and comes with tools for easy implementation. Tools include a Part 11 master plan, SOPs, examples and templates for easy implementation.  
Includes two years on-line updates.
More information and ordering.
Validation Master Plan
Starting point for any validation activity
Master plans are ideal for a consistent and effective validation and answer the FDA inspector's question for a company's approach for validation. such plans are also required by EU and other international GMPs. This plans covers validation of equipment from planning and specifications to installation and qualification for initial and on-going use.
More information and ordering.
  FDA Inspections Package
Avoid  483's and Warning Letters
Learn everything about FDA's inspection and enforcement program through a primer and audio seminar.
Representative examples for GLP/GCP/GMP deviations help to understand what inspectors are looking for and what mistakes other companies make. Checklists, SOPs and other tools help to make preparation, conduct and follow-up of inspections stress-free and successful. 
Includes two years on-line updates.
More information and ordering.
  Network Quality Package
For FDA, HIPAA and SOX Compliance
Networks are considered computer systems and need to be qualified. Through its video presentation and primer this package is ideal to train your IT, QA and User departments on FDA and international requirements. A network qualification plan, a step-by-step implementation plan and SOPs, checklists and examples help to efficiently qualify your network and to validate networked systems.   
Includes two years on-line updates.
More information and ordering.
  Macro and Spreadsheet Quality Package
FDA/EU/SOX compliant validation and use of Excel
Out-of-the box spreadsheet programs such as Excel do not comply with FDA, SOX and international requirements. This package with video presentation and a primer helps to understand requirements. SOPs, project plans, checklists and validation examples help to develop strategies to make Excel and other spreadsheet applications compliant.
Includes two years on-line updates.
More information and ordering.
CD-Validation of Computerized Analytical and Networked Systems
With video training and and SOPs for implementation
Complementary to the book with the same title. A video based presentation guides lab managers, analysts and QA through all validation steps from planning to design, installation on-going use and revalidation after changes.
References includes FDA and international regulations and guidelines. 
Includes two years on-line updates.
More information and ordering.
  Laboratory Data Integrity Package
Helps to ensure data integrity for Analytical Labs
This comprehensive package guides you through the detailed FDA and EU requirements for integrity of electronic records. The more than 30 best practice guides such as templates/SOPS/examples will ensure overall cost-effective implementation. 
Comes with audio seminar. ncludes two years on-line updates.
More information and ordering.
Risk Management Master Plan
For FDA compliance and efficient use of resources
Understand FDA requirements for risk assessment and management. Learn how to define risk categories for equipment and computer systems. With SOP and templates to define risk based validation tasks and FDA compliant documentation.  
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  Validierung computergesteuerter Analysensysteme
Fuer effiziente und kostenguenstige Validierung
Unverzichtbarer Ratgeber fuer den Praktiker für den gesamten Validierungsprozess. Die angebotenen Strategien, Checklisten, Beispiel-SOPs und ueber 100 Referenzzitate fuehren nicht nur zu einer schnellen und zuverlaessigen sondern auch zu einer kostenguenstigen Validierung  
More information and ordering.