Analytical Method Validation Best Practices for Pharma Companies

Loren Gelber

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This analytical method validation webinar will help you understand the various parameters required for a successful method validation. It will highlight various requirements of USP and FDA for a successful method validation. This will be helpful for All pharmaceutical analytical chemists & supervisors responsible for validating new or modified analytical methods, and the personnel responsible for hosting FDA inspections, responding to 483s and Warning Letters or preparing NDAs or ANDAs.

Why Should You Attend:

Method validation is often cited in FDA inspectional observations, Warning Letter violations and reviewer comments regarding NDA and ANDA submissions. All analytical methods developed by pharmaceutical companies require method validation, as do any changes to compendia methods. Even if the compendia method is used unchanged, its suitability for the finished product in question should be demonstrated.

Selectivity, linearity, accuracy, precision, sensitivity, ruggedness and inter-analyst variability are among the method parameters that are measured during method validation.

Attend this webinar to understand each of the above parameter in details including the establishment of limits for determining whether the method passes this parameter. USP, FDA and other requirements for successful method validation will be presented.

Areas Covered in the Webinar:

  • Reasons for validation
  • Protocol or SOP
  • Selectivity – do this first
  • Linearity
  • Precision
  • Sensitivity
  • Ruggedness
  • Inter-analyst variability

Who Will Benefit:

  • Analytical Chemists responsible for Method Validation
  • Supervisors and Managers of Analytical Chemists
  • Those responsible for hosting FDA inspections, responding to 483s and Warning Letters
  • Regulatory Affairs or those preparing NDAs or ANDAs
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Loren Gelber, Regulatory Compliance Consultant (Ex-FDA Official)

Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. She participated in the development of method validation requirements for HPLC analytical methods. She then transitions to industry, working for four different pharmaceutical companies. For the last 13 years she has been a regulatory compliance consultant, both for consulting companies and independently.

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