Selection and Use of (Certified) Reference Material- Strategies for FDA Compliance and Tools for Implementation

Why Should You Attend:
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.

Attend this Webinar to understand the requirements of ISO 17025 and ISO 34. Get an insight in to the hierarchy of reference materials and learn how to prepare and test it. Our expert Dr. Ludwig Huber will also discuss traceability of primary/secondary standards and reference materials and how to prepare the working standards from these standards. How do you save costs by optimizing the uses of the reference materials?

Hand-Outs:

For easy implementation, attendees will receive

• 4 SOPs
  • Handling (Certified) Reference Material
  • Purchasing and Receipt of Supplies for Laboratories
  • Quality Assessment of Laboratory Suppliers
  • Preparation of Laboratory Working Standards
• Checklist: Handling (Certified) Reference Material

Note: These complimentary hand-outs will be sent to customers on request. Please email [email protected] for these documents, stating your order number, and they will be emailed to you within 4 working days.

Areas Covered in the Seminar:

• The role and importance of reference material in chemical measurement.
• FDA and international requirements.
• Requirements of ISO 17025 and ISO 34.
• Official and industry guidance documents.
• Hierarchy of reference material.
• 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.

Who Will Benefit:

• By Laboratory/Industry
  • Pharmaceutical development and quality control laboratories
  • Food, environmental, clinical and chemical testing laboratories
  • Suppliers of reference material
  • Contract laboratories
• By function
  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Training departments
  • Documentation department
  • Consultants

Instructor Profile:
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber’s website: www.ludwig-huber.com

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