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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)Learn from the convenience of your desk or with your colleagues in a seminar room
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On-line Audio Seminar 210

Effective Gap Analysis for ISO 17025

With Practical Tools for Easy Implementation

Recorded

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ISO 17025 is  the recognized global standard for laboratory accreditation. It is required by many private and public organizations as a prerequisite for business contracts and such accreditation status significantly improves the image of the laboratory and its employees. Getting ISO 17025 accreditation is easier  than most people think. The reason is that many of the requirements are already implemented in one or the other way bit not fully documented. Therefore a gap analysis is the first and most important step in the whole process. The objective is to find out what is it that needs to be done in addition to what is already available. However many laboratory managers  don't know how to conduct a gap and even less they have the right tools for efficient implementation.    

Key Questions related to ISO 17025 gap analysis are:

  • We believe we have quite good analytical working practices, is this enough?
  • How to find the real ISO 17025 requirements, the text in the standard is too high level?
  • What are the steps for an effective gap analysis?
  • How long does a gap analysis take?
  • What is the benefit of ISO 17025 for pharmaceutical laboratories?
  • We are already certified for ISO 9000, what do have to do for ISO17025?
  • We are already certified for GLP, what do have to do for ISO17025?
  • Who should do the gap analysis?
  • Are there tools available for an efficient gap analysis?
  • How much does ISO17025 implementation and accreditation cost?
  • What is the most effective way to get ISO17025 accreditation?
  • What is most likely to go wrong?

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:

  • Overview and benefits of ISO 17025
  • Definition and scope of gap analysis
  • Key reasons for a gap analyis
  • Difference to inspections and accreditation assessment
  • Introduction to the gap analysis process
  • Preparation of laboratory staff for the gap analysis
  • The right format of the gap analysis questionnaire
  • Filling the questionnaire with the right content: copying the 17025 text is not enough!
  • Documenting the gaps and required actions for each defined requirement.
  • Converting your current work practices to ISO 17025 compliance with minimal effort
  • Real cost estimates for implementing ISO 17025
  • Avoiding frequent pitfalls

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
    - Conducting a Gap Analysis for ISO 17025
    - Laboratory Complaint Handling
    - Document Management and Control
    - Auditing Analytical Laboratories
    - Training of Laboratory Personnel
    - Qualification of Equipment
    - Conducting Management Reviews
  • Examples
    - Gap Analysis Tool for ISO 17025
    - Required Laboratory Procedures for ISO 17025
    - Required Laboratory Records for ISO 17025
  • Checklist/Worksheet
    - ISO 17025 Accreditation
    - Laboratory Audits
  • Forms
    - ISO 17025 Laboratory Gap Analysis Project Team
    - Worksheet for ISO 17025 Gap Analysis
    - Documenting Corrective Actions for ISO 17025
    - Excel Spreadsheet to Estimate Cost for ISO 17025
  • 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

  • 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.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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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.-
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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 editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

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 visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.