Validation and Qualification in Analytical Laboratories

Second Edition Available

Intro

 

This validation reference book from Ludwig Huber guides quality assurance managers, laboratory managers and analysts in chemical analytical laboratories through all validation and qualification processes. Readers will learn how to develop and implement a validation strategy for a routine, non-routine and standard analytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Finally it guides readers through stress less internal and 3rd party laboratory audits and inspections.

The new 2007 edition has been updated throughout all chapters and new chapters have been added on risk assessment, validation for Part 11 compliance, transfer of analytical methods, handling out-of-specification situations and ISO17025.

When you purchase the book through the Labcompliance  you get two years on-line update through a password protected internet site. This keeps you up-to-date with ever changing FDA expectations long after you have bought the book.

 

Highly visual content with bulleted step by step instructions. Case studies, checklists, templates and key standard operating procedures make it easy not only to learn the subject but also to quickly implement the recommendations.

It takes account to most international and national regulations and quality and accreditation standards such as GLP, cGMP, CGP from US FDA and EU, accreditation standards such as ISO17025 and to corresponding interpretation and inspection guides. Readers of the book learn how to speed up the validation processes in the analytical laboratory and how to do it right the first time thus avoiding troublesome rework and getting confident for stress-free audits and inspections.

Contents

• Overview on regulations, quality standards and related guidelines on validation and qualification
  (FDA, EPA, cGMP, GLP, GCP, ISO9000, USP, ISO 17025, how to deal with multiple regulations and Quality Standards)
• Developing an overall validation strategy
  (Terminology, validation needs, strategy for implementation)
• Risk based validation and qualification
• Calibration, verification and validation of equipment
• Analytical instrument qualification:
  - planning
  - design qualification
  - installation qualification
  - operational qualification
  - performance qualification
• Validation of software and computer systems
  (Standalone computer systems, networks, macros, spreadsheets)
• Validation for Part11 compliance
• Validation of analytical routine, non-routine and standard methods
• Transfer of analytical methods and verification of standard methds
• Review and validation of data
• Measurement and documentation of uncertainty
• Handling out-of-specification situations
• Qualification of chemical standards and (certified) reference standards, preparation of working standards from certified reference material (CRM), traceability to national standards, testing of working standards, correct use of certified reference material, quality assurance program for standards
• Qualification of people
  (Recruiting of qualified people, training, documentation)
• Proficiency testing for external analytical quality control
  (procedure, purpose and evaluation of proficiency testing, who should participate, frequency of tests, evaluating and reporting results)
• Stress free internal and 3rd party audits
• Case studies, standard operating procedures, templates and examples for easy implementation
• Test guidelines for 30 different instruments
• Literature references
• Glossary
• Standard operating procedures
  (SOP for preparation of SOPs, Validation of analytical methods, Testing precision of peak areas and retention times in HPLC, Retrospective evaluation and validation of equipment)
• Selected case studies for OQ (specifications, testing)
• OQ tests for selected equipment
  (tests for about 30 different instruments incl. GC, HPLC, CE, UV-Vis, IR, balances, ovens, pH-meters, Karl Fisher, dissolution testing, viscosimeter, melting point, refractometer, polarimeter, sterilizers, refrigerator)
• Example for OQ certificate

Target Audience

• Lab managers and personnel
• QA managers and personnel analytical scientists
• Validation specialists
• Consultants
• Teachers

Free Online Updates

On-line updates - keeps you on top of ever changing regulatory requirements

Working in a regulated laboratory is quite challenging. Regulatory agencies and industry task forces frequently release or update regulations or guidance documents.

A book can give the background, the fundamentals and an overview on regulations and inspection practices at a particular point in time - but updates reflecting on-going changes are practically limited to a 2 to 5 year time frame.

The Internet with it's instant publication power can give this update on a much more frequent basis, but is not so popular to learn the fundamentals. The real solution is a combination of both: get the book for the fundamentals and the Internet for the updates. That's why the author offers two year on-line update with the purchase of a book.

 

Registration is automatically with each package purchase from Labcompliance

Click here to go to the update site (requires access information)

Format/Price

• Format: Bound book, hard cover
• Size: 303 Pages
• Labcompliance Price: US$ 259.-
  (includes shipping and free on-line update for two years).
• VAT will be added for EU countries.
• Availability: Worldwide, shipment within one working day
• Ordering through Labcompliance:
  (SSL secured, recommended for payment by credit card)
  - Electronically from this this web site (SSL secured)
  - Regular mail or fax using the form in PDF or MS Word format
• Ordering from any conventional or on-line book shop such as Amazon
   Refer to Informa publisher, ISBN 0-8493-8267-X,
  such orders do not include on-line updates

Bundle: Book plus CD - 12% savings

 

1. Includes the book: Validation and Qualification in Analytical Laboratory
   Handy Validation Reference for your entire laboratory
2. CD: Validation and Qualification in Analytical Laboratories
   - Interactive video for quick introduction and overview
   - SOPs, examples, checklists for easy implementation
   - Regulations, guidelines as reference material
3. On-line update for 2 years
   - Keeps you up-to-date with ever changing FDA expectations

The author

The author, Dr. Ludwig Huber, is an international expert on validation and compliance in regulated industries and laboratories. He has been responsible for the compliance program at Hewlett Packard and Agilent Technologies for more than fifteen years. He serves as a consultant for the industry and regulatory agencies on local and international compliance 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 on the advisory board for the European Compliance Academy and is a member of IVT task force on network qualification. 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