ComplianceOnline

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

Instructor: Dr. Ludwig Huber
Product ID: 700900
  • Duration: 80 Min

recorded version

$399.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Mar-2010

Training CD / USB Drive

$700.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Webinar will highlight the requirements of ISO 17025 and ISO 34 and explain the preparation, testing of certified reference materials along with assessment of suppliers of reference materials.

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 customercare@complianceonline.com 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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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