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
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On-line Audio Seminar 253

FDA Compliant Use of (Certified) Reference Material

Strategies for selection, purchasing, testing and documentation

Recorded, available at any time

Most important for getting correct analytical results is the use of accurate standards or (certified) reference materials. No matter how skilled the analysts are or how sophisticated and automated the equipment, if the calibration of the system is incorrect, the analytical result will always be wrong. Because of this FDA inspectors expect companies to have validated processes for the selection, purchasing, testing, storage and use of (certified) reference material.

Key Questions related to (certified) reference material are:

• What is the difference between primary and certified reference material?
• What is standard reference material?
• What are FDA/EU requirements for (certified) reference material?
• What are requirements of accreditation bodies in US and EU
• Certified reference material is quite expensive, can we prepare and use our own?
• There is no certified reference material for our analyte, what to do?
• Do we have to determine expiration dates of our standard?
• How to prepare working standards from primary standards?
• How to assess suppliers of reference material?
• How to qualify incoming reference material?
• How to proof and document traceability to national standards?
• How to decrease costs of using expensive reference material

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:

• The role and importance of reference material in chemical measurement
• FDA and international requirements
• Official regulatory and industry guidance documents
• Hierarchy of reference material
• Risk based selection or suppliers
• Preparation and Testing of Certified Reference Material
• Traceability of primary/secondary standards and reference material
• Preparing working standards from primary and secondary standards
• Developing an SOP for preparation of working standards
• Assessment of suppliers of reference materials
• Practical approaches for qualification of incoming material
• Optimizing the uses and the costs of reference materials
• Documentation for the FDA  and ISO

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

• SOPs
  - 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
  
• Templates/Checklist:
  - Handling (Certified) Reference Material
• Reference Articles
  - Qualification and Certification of Certified Reference Material and Working Standards 
  
• Five Warning letters and/or Inspectional observations related to reference material
• NIST Special Publication:
  Standard Reference Material
• EURACHEM: Selection and Use of Reference Material
  A Basic Guide for Laboratories and Accreditation Bodies
• EURACHEM Guide: Traceability in Chemical measurement
• ILAC Guidelines for the Selection and Use of Reference Material

Who should attend?

• QA managers and personnel
• Analysts and lab managers
• Validation specialists
• Training departments
• Documentation department
• Suppliers of reference material
• 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.

Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:  Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,