Analytical Method Validation Best Practices for Pharma Companies
Instructor:
Loren Gelber
Product ID: 705838
Training Level: Intermediate
- Duration: 90 Min
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
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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