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 237

How to Efficiently Get ISO 17025 Accreditation

Step-by-step from the idea to cost-effective implementation

 Recorded

Getting ISO 17025 accreditation expands a laboratory's business opportunities but there are also costs involved. Many organizations only contract analyses to accredited laboratories. However, because of the standard's requirements ISO 17025 accreditation needs to be thoroughly budgeted, planned, designed and implemented. This holds for planning of organizational and management structure, for facilities and equipment, and for documented staff training. 

Key Questions related to building an ISO 17025 laboratory are:

• Who should get accreditation?
• We already have GLP, how to upgrade to ISO 17025?
• We already are GMP certified, how to upgrade to GLP?
• We are already ISO 9001 certified, can we leverage SOPs and other documents?
• How long will it take from the 'go' decision until we get accreditation status?
• How much does it cost?
• What are the deliverables?
• Our laboratory only has five employees, is this enough for ISO 17025
• What are the management and organizational requirements?
• Which type of documents should be developed?
• Do we need any additional people with different qualifications?

How does the audio seminar help:

A good understanding of ISO 17025 requirements together with a good strategy for planning, design and implementation not only can keep the costs under control but provides assurance that the lab will pass initial and on-going assessments. Answers to the questions above 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, checklists, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• Key ISO 17025 Requirements
• Main differences to ISO 9001, GLP and GMP
• Main difference to CLIA and to ISO 15189 for medical laboratories
• Benefits of ISO 17025 accreditation
• The importance of the scope of the accreditation
• Costs for implementation: personnel, equipment, documentation
• Estimating return of investment
• Selecting the accreditation agency
• Making a realistic project schedule
• Main reasons for delays and increased costs
• Upgrading from existing GLP, GMP and/or ISO 9000.to ISO 17025
• Sharing best practices
• Frequently asked questions
• Most common pitfalls

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

• PowerPoint Presentation
• Script
• All questions and answers from before, during and after the seminar
• Primer ISO 17025 for laboratories
• Laboratory Quality Manual: Template and examples
• ISO17025: Step-by-step implementation
• SOPs
  - Conducting a Gap Analysis for ISO 17025
  - Recording and Archiving of Records for ISO 17025
  - Internal Audits for ISO 17025
• Examples/Templates
  - Gap Analysis Tool for ISO 17025
  - Required Laboratory Procedures for ISO 17025
  - Required Laboratory Records for ISO 17025
  - Project Schedule for ISO 17025 Accreditation
  - Project Cost for ISO 17025 Accreditation
• Checklist/Worksheet
  - ISO 17025 Accreditation
  - Laboratory Audits
• Forms
  - ISO 17025 Laboratory Gap Analysis Project Team
  - Excel Spreadsheet to estimate Cost for ISO 17025
• And more...

Who should attend?

• Food, environmental, chemical and pharmaceutical testing laboratories
• Laboratory managers and staff
• Analysts
• QA managers and personnel
• Training departments
• Documentation department
• Consultants

Date, time and duration

Order at any time, replay at any time, download the reference material at any time.

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.