Validation of Analytical Methods and Procedures

Dr. Ludwig Huber
Dr. Ludwig Huber
Friday, April 23, 2021
10:00 AM PDT | 01:00 PM EDT
75 Minutes

More Trainings by this Expert   Product Id : 503671

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$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

This webinar will provide a good understanding on how to effectively conduct and document method validation, method re-validation and periodic review.

Reference Material for Easy Implementation

  • SOP: Transfer of Analytical Methods
  • Checklist: Transfer of Analytical Methods and Procedures
  • Master Plan Template and Examples: Transfer of Analytical Methods and Procedures

Areas Covered in the Session:
  • Current and new guidelines from FDA, WHO, EMA and USP
  • Examples of warning letters and how to avoid them
  • Developing an SOP for method validation
  • Development of a validation plan for success
  • Prerequisites for method validation
  • Defining the minimum number of validation experiments that satisfy ICH, FDA and USP
  • Defining test conditions and acceptance limits
  • Verification of compendial methods according to USP <1226>
  • To revalidate or not after method changes
  • Ensuring on-going method performance through periodic review
  • Transferring a method to routine according to USP <1224>
  • Seven most common method validation pitfalls and how to avoid them
  • Documentation for the FDA and for other agencies

Who Will Benefit:
  • Laboratory Managers and Supervisors
  • GLP/GCP/GMP Auditors
  • ISO 17025 Auditors
  • QA/QC Managers and Personnel
  • Analysts and Other Laboratory Staff
  • Regulatory Affairs
  • Training Departments
  • Consultants

Speaker Profile
Dr. Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber's website

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