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 189

Understanding and Implementing ISO 17025

Requirements, Strategies and Tool Kits for Laboratory Accreditation

Recorded

ISO 17025 can be used by laboratories as a standard to develop and establish a Quality System in the laboratory and for the assessment by their clients or by third parties. The standard is also being used as a criterion for laboratory accreditation. While the FDA does not formally require ISO17025 accreditation regulated pharmaceutical laboratories are advised to study the standard for a number of reasons. FDA operates laboratories according to ISO17025 so inspectors are familiar with it. FDA is more and more referring to official global standards and last but not least: there is no such detailed document from the FDA on building up a quality system for analytical laboratories. However, introducing ISO17025 raises a number of questions.

Key Questions related to ISO 17025 are:

• Which laboratories should comply with ISO17025?
• We are ISO17025 accredited, is this enough for GMP and GLP inspections?
• What are the management requirements of ISO17025?
• What are technical requirements of ISO17025?
• What is the benefit for pharmaceutical laboratories?
• We are already certified for GLP, what do have to do for ISO17025?
• How much does ISO17025 implementation and accreditation cost?
• What is the most effective way to get ISO17025 accreditation?
• How to select an organization for accreditation?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, 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:

• Benefits of ISO 17025
• Management requirements
• Technical requirements
• Documentation requirements
• Steps towards ISO 17025 laboratory accreditation
• ISO 17025 and the FDA
• Impact on Analytical Laboratories
• Recommendations for implementation
• Dealing with multiple quality systems
• Preparation for an ISO 17025 Audit
• Local and global resources

And for easy and instant implementation:
download 10+ documents from special seminar website

• Laboratory Quality Manual: Template and examples
• ISO17025: Step-by-step implementation
• SOPs
  - Laboratory Complaint Handling
  - Document Management and Control
  - Auditing Analytical Laboratories
  - Training of Laboratory Personnel
  - Qualification of Equipment
  - Conducting Management Reviews
• Templates/Checklist:
  - ISIO 17025 accreditation
  - Laboratory Audits
• Reference Articles
  - Qualification and Certification of Certified Reference Material and Working Standards
  - How an Instrument Vendor can help with ISO 17025 Accreditation
  - Validation of Analytical methods: review and strategies
• EURACHEM Guide
  - Quantifying Uncertainty in Analytical Measurement
• EURACHEM: Selection and Use of Reference Material
  - A Basic Guide for Laboratories and Accreditation Bodies (link)
• EURACHEM Guide:
  - Traceability in Chemical measurement (link)

Who should attend?

• QA managers and personnel
• Analysts and lab managers
• Validation specialists
• Training departments
• Documentation department
• Consultants

How to order

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

Recorded seminar - Web download 'Site' offer 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.