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All come with 10+ Best Practice Documents: SOPs, Checklists, Examples

 

FDA Compliance for Biochemists and Biologists

Get an Overview on Regulations and Key Requirements in just one Hour

Recorded, available at any time

 

Analytical Instrument Qualification According to USP <1058>

Get an Overview on Regulations and Key Requirements in just one Hour

Recorded, available at any time

 

Validation of Analytical Methods and Procedures

Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance

Recorded, available at any time

February 28, 2008

Transfer of Analytical Methods and Procedures According to USP <1226>

FDA Requirements, Strategies and Tools for Implementation

Recorded, available at any time

 

Effective Verification of Compendial Methods

Understanding the New USP Chapter <1226>

Recorded, available at any time

 

System Suitability Testing in Compendial Chromatographic Methods

Understanding and Implementing Recent Changes of USP and EP

Recorded, available at any time

 

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

Sample generation - method development - validation - documentation

Recorded, available at any time

 

Primers from Agilent

Agilent has developed several primers that help Agilent customers to understand and meet GMP, GCP, GLP and ISO/IE 17025 compliance in laboratories. All primers have been written by Dr. Ludwig Huber.

Good Laboratory Practice and Good Manufacturing Practice

This 116-page primer written by Dr. Ludwig Huber gives an overview of FDA and international requirements for Good Laboratory Practice and Good Manufacturing practices as they relate to development and quality control laboratories. After a historical background  the general requirements such as organizational structure, personnel, handling of raw data and documentation are discussed. The next chapter deals with validation requirements for instruments and methods. The primer also gives recommendations on how vendors of equipment and service providers can help clients to comply with GLPs and GMPs.  For more information and ordering or download the primer click here

Analytical Instrument Qualification and System Validation

This 60-page primer written by Dr. Ludwig Huber, guides analysts, laboratory managers, quality assurance managers and IT and validation professionals through instrument and system validation at minimal extra cost. Following a literature and regulatory overview, this primer provides information on the entire qualification and validation process from planning, writing specifications as well as vendor qualification to installation, initial and on-going operation. Special focus is placed on getting a good understanding of and implementing USP chapter <1058>. After an introduction to the chapter’s approach for instrument qualification and system validation, this primer will lead you through individual qualification phases and give recommendations for implementation. For more information and ordering or download the primer

Compliance for Biopharmaceutical Laboratories

This 46-page primer is intended to introduce biochemists and biologist working in biopharmaceutical development and manufacturing to FDA and equivalent international requirements. It is also useful for quality managers and staff and for everyone else involved in the registration process of biopharmaceuticals. The primer also gives strategies and specific recommendations for regulated laboratories on how to implement the requirements in the most cost effective way.

For more information and ordering or download the primer click here

Validation of Analytical Methods

This 76-page primer is intended to guide managers and analysts from (bio)pharmaceutical, food, chemical, environmental  and other regulated  laboratories through all aspects of analytical methods validation. Quality managers and staff as well as regulatory affairs professionals will also benefit through extensive discussions of relevant regulations, quality standards and guidelines. The primer will give strategies and specific recommendations for validation of new methods that are developed in-house as well as for verification of compendial and standard methods.

For more information and to download the primer click here

Compliance by Design for Pharmaceutical Quality Control Laboratories - Insight from FDA Warning Letters

This 31-page primer focuses on frequently cited compliance deviations observed during FDA inspections. Several hundred GMP-related Warning Letters and inspection reports were analyzed. Readers can use this information to educate themselves on the current thinking of FDA inspectors as well as past mistakes made by other companies and how to avoid them. Based on information from these citations, certain best practices that can help design regulatory compliance into quality control laboratories have also been included.

For more information and to download the primer click here

Elemental Impurity Analysis in Regulated Pharmaceutical Laboratories

This 44 page primer gives an overview of regulatory requirements for the analysis of elemental impurities according to the new USP chapters <232> and <233<>. It guides analysts, laboratory managers, IT administrators, quality assurance managers and validation professionals through the entire process from instrument qualification, through method and system validation, to ensuring compliance of electronic records. Readers of this primer will learn how to speed up their validation and qualification process, thereby avoiding troublesome reworking and gaining confidence for audits and inspections

For more information and to download the primer click here

Genotoxic Impurities in Pharmaceutical Products - Regulations and Analysis

The intent of this 32-page educational guide is to give managers and staff in quality assurance and operational departments a synopsis of the regulatory requirements associated with genotoxins, as well as recommendations for their implementation. It is also designed to provide an overview of relevant analytical instrumentation with useful references to valuable scientific publications that demonstrate their operation.

For more information and to download the primer click here

Validation and Qualification for Supercritical Fluid Chromatography

This 73-page primer guides analysts, laboratory managers, quality assurance managers and validation professionals through the entire process from SFC instrument qualification to method and system validation. 

For more information and to download the primer click here

Understanding and Implementing ISO/IEC 17025

This 62-page primer is intended to give a brief introduction to ISO/IEC 17025: the global standard for Laboratory accreditation. After reading this primer, laboratory managers, staff, and others who might be affected by ISO/IEC laboratory accreditation should:

  • Understand the benefits of laboratory accreditation.
  • Have an overview of management and technical requirements.
  • Know what steps are required to evaluate whether or not laboratory accreditation makes good business sense.
  • Be familiar with implementation steps.
  • Know the types of documentation required.
  • Know how to prepare a laboratory for internal and external audits.

For more information and ordering or download the primer

 

ISO/IEC Accreditation Package from Labcompliane

ISO  17025 Accreditation Package
For Fast and Trouble Free Laboratory Accreditation
Understand the ISO 17025 quality standard for testing and calibration laboratories. The package comes with an audio seminar, a quality manual, 39 SOPs, forms. templates and and checklists for easy implementation. 
More information and ordering.

Testimonials/References from Users of the Package

 

 

The Feedbacks on the Package have been received by e-mails. Labcompliance has permission to use the testimonials as references. Original e-mails are stored in the Labcompliance archive.

  • Mr. Andrew Glum, Director of Special Products and Quality Manager, Madge Tech, Inc., USA
    The package did exceed my expectations. The ISO 17025 Labcompliance Accreditation package is very insightful, practical, easy to understand, and there are a ton of additional resources offered to download when you have purchased this package for your laboratory accreditation and implementation of ISO 17025. Our Laboratory Manager, myself (quality manager, safety chair, director of special projects), and our Vice President of Operations are all very glad that I chose to buy the Labcompliance package. Just after two implementation meetings, the vice president of operations said "wow, this is actually good", and referring to certain sections of the laboratory quality manual: "this is good stuff!".
    The manual uses a consistent structure and terminology which applies throughout the manual and SOP's which makes it very easy to understand and incorporate into your companies existing quality management system, or to implement for the first time a great laboratory quality management system. I highly recommend the complete ISO 17025 Laboratory Accreditation Package to any company with a testing / calibration laboratory. Trust me, I have done my research and due diligence. This is
    the best one out there; don't waste your time looking for others that could lead you down a wrong path. When you get this package and start reviewing it, you will say to yourself "this is a LOT of work"; but then you will say, "Boy am I glad I bought this!"  (Ref 1085)

  • Mr. Russell Hensel, President, Hensel Environmental Biology Laboratories, USA
    The package did exceed my expectations. It gives us a HUGE head start on the lab start up. The cost is minimal compared to the return. EXCELLENT documentation. (Ref 1048)

  • Dr. Andrew Wotherspoon, National Research Council, Bioanalytical Chemistry,  Canada
    The ISO17025 is a comprehensive resource for all your accreditation needs. Explanations of key points of the accreditation process are well explained and there is extensive supporting material (SOP's etc) to allow an organization to successfully speed along the implementation process. SOP's and Forms are well written and satisfy the principal components of ISO17025 guidelines. Access to the website provides a source to access any updates to documentation. (Ref: 1017)

  • Ms Rona Canilao, Trans World Trading Co, Chief Chemist, Chemical Department, Philippines
    The package did exceed my expectations. It was very helpful on the start-up of our laboratory especially on our documentation system. It is a complete package. The necessary requirements for ISO accreditation are there. Ms Rona Canilao, Trans World Trading Co, Chief Chemist, Chemical Department, Philippines (Ref 1086)

  • Kellie Sorrell, Metrology Solutions Inc., Quality Department, Country, USA
    The templates were very useful in starting from the ground floor. Everything really fits together. Website is very helpful. The package did exceed my expectations. (Ref 1013)

  • Peggy Weber; Accelerated Technology Laboratories (ATL); USA,
    Project Manager

    The package did exceed my expectations. The number of documents especially dealing with the IT side of use in Lab environment exceed what I was expecting for the purchase. I wish a couple years ago I knew of this website and access. I do know that I will recommend this to others. (Ref: 1020)

  • Ms.Tiffany Weldin, Quality Systems Director, Primex Farms, LLC, USA
    Documents were thorough and self explanatory. Great Resource!! I would definately recommend. The package did exceed my expectations, (Ref T-1031)

  • Ms. Brad Whisson, Managing Director, West Minerals Analysis Pty Ltd, Australia
    The package was a good starting point for our ISO17025 compliance program. It ensured that we did not overlook key requirements, and saved a lot of time in providing a framework to build on. The ISO 17025 Accreditation Package download from Labcompliance gave us a head start in our ISO17025 compliance program and significantly decreased the resources required.
    (Ref T-1030)

  • Ms.Kathryn Wadle, Technician, Texas Engineering Exp. Station, Energy Systems Lab (ESL), USA
    The procedure for each clause specified in the ISO 17025 has been clearly identified and documented through SOPs.
    The package did exceed my expectations. (Ref T-1029)

The author

Picture of Ludwig Huber

The author, Dr. Ludwig Huber, is an international expert on laboratory compliance and quality standards. He has been responsible for the compliance and quality standards program at Hewlett Packard and Agilent Technologies for more than 20 years. He serves as a consultant for the industry and agencies on local and international compliance and quality issues. He has been a member of the US PDA task force on 21 CFR Part11 and of the GAMP Special Interest Group for Laboratory Computer Systems. He is also was/is on the advisory board for the European Compliance Academy and IVT's GxP Journals. Several of his previous books have been bestsellers and several times he has been ranked as number one presenter at various international conferences. For publications, presentations and other achievements, click here