ComplianceOnline

Validation of Analytical Methods and Procedures - Design, Conduct and Document for Efficiency and Compliance

Instructor: Dr. Ludwig Huber
Product ID: 700158
Training Level: Advanced
  • Duration: 60 Min

recorded version

$249.00
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

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Validation training will guide attendees through the entire process from defining specifications, through developing and implementing validation experiments to FDA compliant documentation.

Why Should You Attend:

Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. This seminar will guide attendees through the entire process from defining specifications, through developing and implementing validation experiments to FDA compliant documentation.

What Attendees will Learn:

  • FDA regulations and guidelines
  • Developing an SOP for method validation
  • Development of a validation plan
  • Defining parameters and acceptance limits
  • Validation of standard/compendial methods
  • Change control and revalidation
  • Transferring a method to routine or other sites
  • Using software for automated method validation
  • Documentation for the FDA and other agencies

Additional benefits:

Attendees will receive two SOPs, Validation of Chromatographic Methods, Transfer of Analytical Methods.

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.

Who Will Benefit:

Everybody involved in the validation of analytical methods.

  • Analysts and lab managers
  • QA managers and personnel
  • Validation specialists
  • Regulatory affairs
  • Documentation department
  • Consultants

Instructor Profile:

Ludwig Huber, Ph.D., is Compliance Program Manager at Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books "Computer System Validation", "Network Quality Package" , and "Validation of Computerized Analytical and Networked Systems".For more information, visit Dr. Huber’s website: www.ludwig-huber.com

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