4 hr Virtual Seminar: Validation of Analytical Methods and Procedures

Instructor: Dr. Ludwig Huber
Product ID: 702007
  • Duration: 4 hrs

Training CD

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


Read Frequently Asked Questions

This webinar will clearly explain the regulatory requirements (FDA, USP, ICH, EMA) for Validation of Analytical Methods and Procedures and present practical approaches for implementation.

Why Should You Attend:

Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data.

In this interactive one-day on-line seminar the speaker will give an introduction to FDA, USP and ICH and other requirements and present approaches for implementation. Attendees will have the opportunity to ask questions and get practical experience through exercises that are inter-dispersed within and between the presentations.

Attendees will receive full set of validation documents that can be used as templates and examples for validating user applications.

Areas Covered in the Seminar:

  • FDA/EU, ICH, USP and ISO 17025 requirements, regulatory expectations and inspection practices.
  • FDA enforcement and inspection practices: Examples of FDA Warning Letters.
  • Nine validation parameters and acceptance criteria for method validation.
  • Writing the validation plan.
  • Designing the sequence of experiments for highest efficiency.
  • Evaluation and presentation of validation results according to ICH.
  • Writing the validation report.
  • Verification of compendial methods according to USP <1226>.
  • Transfer of analytical methods according to USP <1224>.
  • Revalidation yes or no after changing methods: real world examples.

Learning Objectives:

Within only four hours, attendees will

  • Understand regulatory requirements for validation of analytical methods and procedures: FDA, USP, ICH, EMA
  • Learn how to define  the minimum number of validation experiments that satisfy ICH, FDA and USP
  • Understand how to define realistic acceptance criteria for compliance
  • Learn how to document validation studies for compliance
  • Learn how to verify standard and compendial methods according to USP <1226>
  • Understand when method modifications require partial and full re-validation
  • Learn how to formally transfer analytical procedures according to USP <1224>

Exercises, Examples and Interactive Discussions:

Practical examples, case studies and exercises will be dispersed into and between the presentations. About 50% of the time will be dedicated to discussions and practical sessions.

As an example, attendees will receive fill-in templates to document validation steps from beginning to end, in other words, from validation planning and writing specifications to testing and writing the validation report. Application examples will be generic and easy to understand. The results will be discussed and conclusions will be documented by the presenter and will be available for download from a special reference website. Attendees can use the templates to validate and document their own analytical methods and procedures.

At the end of each module participants can ask verbal questions through the audio line. Written questions can be submitted at any time before and during the seminar and will be answered in Q&A sessions.


4 hours of instruction, exercises and discussions, one hour lunch, 15 min breaks as they fit into the schedule

Agenda: (All time in EDT):

  • 11.00-11:20 FDA and international requirements and enforcement
  • 11:20-12:00 Validation parameters and acceptance criteria
  • 12:00-01:00 Planning and execution of validation experiments
  • 01:00–01:15 Break
  • 01:15-01:45 Evaluation and reporting of results
  • 01:45-02:15 Revalidation, stability indicating methods
  • 02:15-02:35 Verification of compendial methods
  • 02:35-02:55 Transfer of analytical methods and procedures
  • 02:55-03.15 Wrap-up and final discussion

Detailed Agenda:

Module 1: FDA and International Requirements and Enforcement (60 min)

  • FDA, ICH, and USP requirements
  • Requirements along the drug development and quality control
  • Examples of FDA 483's and Warning Letters
  • Nine validation parameters according ICH Q2
  • Regulated vs. non-regulated experiments
  • Acceptance criteria for all validation and test parameters
  • Workshop exercise
  • Interactive discussion

Module 2: Planning and Execution of Validation Experiments (60 min)

  • Defining the minimum number of experiments to satisfy FDA, ICH and USP: examples for robustness, intermediate precision, linearity, range and accuracy
  • Integrated method development and validation
  • Required tasks during method development
  • Prerequisites for experiments: training, equipment qualification, materials
  • Developing the validation plan
  • Designing sequence of experiments for highest efficiency
  • Workshop exercise
  • Interactive discussion

Module 3: Evaluation and Reporting of Results, Revalidation (60 min)

  • Using Microsoft Excel for calculating and presenting results: repeatability, intermediate precision, reproducibility, linearity, range, limit of detection, limit of quantitation, robustness and specificity
  • Going through a validation report - from beginning to end
  • Special considerations for stability indicating methods
  • Post validation activities: Going through seven real world method modifications with and without the need for revalidation
  • Revalidation yes or no after method adjustments
  • Workshop exercise
  • Interactive discussion

Module 4: Verification of Compendial Methods and Method Transfer (60 min)

  • Transfer of analytical methods according to USP <1224>
  • The difference between validation and validation
  • Verification of compendial methods according to USP <1226>
  • Workshop exercise
  • Interactive discussion
  • Seminar Wrap-up

Free Handouts:

10+ Reference Documents for Easy Implementation:

This material will help  attendees to quickly implement what they have learned in the seminars

  • 70 page E-book: Validation of Analytical Methods
  • SOPs:
    • Validation of Analytical Methods
    • Change versus Adjustment of Analytical Methods
    • Validation of Stability Indicating Methods
    • Validation of HPLC Methods
    • Verification of Compendial Methods
    • Transfer of Analytical Methods
  • Checklist: Validation of Analytical Methods
  • Templates and Examples
    • Method Validation Plan
    • Method Validation Report
  • FDA 483 form inspectional observations, establishment inspection reports and several warning letters with deviations related to Method Validation

Who Will Benifit:

  • Laboratory management, supervisors and senior analysts
  • QA managers and personnel
  • Regulatory affairs
  • Consultants from
    • Pharmaceutical and API manufacturers
    • Contract laboratories
    • Clinical research organizations
    • Regulatory agencies

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 , 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:

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