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.

	Validation and Qualification in Analytical Laboratories
	The reference text book for lab managers, analysts and QA
	For all validation and qualification activities to comply with GLP, GCP, cGMP and ISO 17025. Covers qualification of equipment, reference material and people and validation of analytical procedures and systems. Includes two years on-line updates. More information and ordering.
	Laboratory Compliance Package
	With 30+ 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 Package
	With 22 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 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 intitial 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.
	Internet Quality&Compliance Package
	Using Internet and Intranet in FDA environments
	Helps to understand FDA and international requirements. Includes strategies and tools for validation of web-based applications, using public e-mail systems and validating applications around Intranet. Comes with audio seminar, master plan and SOPs. Includes two years on-line updates. More information and ordering.
	Validation of Computerized Analytical and Networked Systems
	Reference book for lab managers, analysts, QA and IT
	For all validation and qualification activities to comply with GLP, GCP, cGMP and ISO 17025. Covers validation of software, stand-alone computer systems and networked systems. Includes validation Excel spreadsheets and Part11 specific validation requirements. Includes 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.   More information and ordering.

	Validierung computergesteuerter Analysensysteme
	Fuer effiziente und kostenguenstige Validierung
	Unverzichtbarer Ratgeber fuer den Praktiker fuer 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.

	Labcompliance Super Package - 37% Discount
	The Ultimate Reference for Laboratory Compliance
	Includes two Best Selling reference books, with complementary Video and reference CDs. Also includes the equipment validation master plan, the risk management master plan and a one year usersclub membership.   37% discount compared to individual products. More information and ordering.