Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here)

On-line Audio Seminar 218

Traceability in Chemical Analysis

With strategies and tools for ISO 17025 and FDA compliance

Recorded, Available on Demand

Traceability of reference standards used for qualification and calibration is a requirement of ISO 17025 and regulations such as GLP and CGMP. Frequently traceability is achieved through an unbroken chain of comparisons to primary standards, to national or international standards and ultimately to Système International d’Unités (SI units). Chemical measurements are typically traceable to either a reference material or to a reference method. However frequently this is difficult to achieve because primary reference standards may not include adequate sample matrix, they are expensive and frequently are not available at all. This opens up many questions

Frequent questions related are traceability in chemical analysis are

• What are ISO 17025 and regulatory requirements?
• When and where is traceability required?
• Ho to demonstrate traceability if no primary standards are available?
• How to establish traceability through participation in inter-laboratory experiments?
• How to define 'Acceptable' Uncertainty?
• How to choose reference standards
• How to establish traceability through reference methods?
• How important is measurement uncertainty in traceability assessment?

How does the audio seminar help:

Questions will be answered by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar strategies and procedures will be presented on how to develop, document, maintain and update User Requirements. An extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• Requirements and expectations from ISO 17025 and FDA
• Official guidelines
• The concept of traceability
• Value of traceability for laboratories and customers
• Principles of traceability in chemical analysis
• Practical approaches for analytical traceability
• Establishing traceability through interlaboratory experiments
• Establishing traceability through comparison with reference methods
• Choosing the ideal reference standards
• Requirements for suppliers of (certified) reference material
• Traceability chain of (certified reference material)
• Key steps in attainment of traceability
• Procedure and protocols for traceability
• The importance of uncertainty assessment for traceability
• Ensuring traceability chain when preparing in-house standards
• Documentation of traceability for ISO 17025 and GxP

Get 10+ Documents To Do it Right The First Time:
download from special seminar website

• SOPs:
  - Traceability in Chemical Analysis
  - Handling (Certified) Reference Material
  - Purchasing and Receipt of Supplies for Laboratories
  - Quality Assessment of Laboratory Suppliers
  - Auditing Suppliers of Laboratory Supplies
  - Preparation of Laboratory Working Standards
• Gap analysis/checklists:
  - Traceability in Chemical Analysis
  - Templates/examples
• EURACHEM Guide
  - Traceability in Chemical measurement
  

Who should attend?

• QA managers and personnel
• Analysts and lab managers
• Metrology specialists
• Training departments
• Documentation department
• Consultants
• Testing laboratories working under ISO 17025
• Pharmaceutical development and QC labs

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download Multiple persons - single site Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site. Order includes all reference material.	US$ 399.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 399.-
Special offer for Labcompliance Usersclub Members Recorded Seminar- CD or Web download. Order includes all reference material. for Usersclub information and registration, click here	US$ 299.-

About audio seminars

Online audio seminars are presented over the phone. During the live presentation attendees can:

1. Study the printed slide material
2. Watch the slides on a computer
3. Watch the slides on a video screen in a seminar room
4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.