$1,299 – $1,699

Analytical Method Validation, Verification and Transfer: One and a Half Day...

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San Francisco

San Francisco, CA 94010-9949

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Refunds up to 30 days before event

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Description

In this course, general guideline for the determination of the analytical characteristics for different types of validation procedures is highlighted for the analysis of both the drug substance and drug product. The factors to consider for verification of the compendial procedures will also be discussed. In addition, different approaches for the transfer of analytical procedurefrom one lab (transferring) to other lab(s) (receiving) under different circumstances will be covered. Other related topics for obtaining reliable data will also be discussed. These topics include analytical instrument qualification as well as how to set, handle and monitor specifications.

Due to global nature of pharmaceutical industry, other quality topics on both regulatory (ICH) and compendial (USP) harmonization are also covered. These topics are valuable for scientists directly or indirectly involved with the drug development, analysis. stability studies or regulatory/compendial submissions.

Learning Objectives:

  • Drug Approval Process and Regulatory Requirements (private standards)
  • Pharmacopeias and Compendial Approval Process (public standards)
  • Compendial Harmonization Process
  • Chromatography System Suitability Requirements
  • Allowed Adjustments of Chromatographic System Parameters
  • Analytical Instrument Qualifications including DQ, IQ, OQ, PQ
  • Analytical Method Validation
  • Analytical Method Verification
  • Analytical Method Transfer
  • Alternative to Official procedure and options
  • Analytical Procedure Life Cycle
  • How to Set Specifications and how to handle out-of-specification (OOS) and out-of-trend (OOT) results

Who will benefit:

Pharmaceutical Industry, Contract Laboratories (CRO), government (FDA or regulatory authorities), Academia (pharmacy, Pharmaceutical, Chemistry)

  • Analytical/Chemists
  • Formulation Chemists
  • Lab Supervisors and Managers
  • QC Managers and Personnel
  • QA Managers and Personnel
  • Regulatory Personnel
  • Compendial Liaisons
  • Pharmaceutical scientist/Pharmacists working in Industry
  • Senior or Graduate students (chemistry, pharmaceutical, pharmacy)

Speaker:

Behnam Davani

Behnam Davani
Senior Consultant and Managing Director, Davani Pharmaceutical Consulting

Dr. Behnam Davani is an Independent Senior Consultant and Managing Director of Davani Pharmaceutical Consulting. He has a Ph.D. degree in analytical chemistry and holds an MBA degree. Dr. Davani has more than 28 years of experience in industry, compendial/regulatory science and training. He has extensive experience as faculty for the development and teaching of several compendial and cGMP courses both domestically and internationally for USP Global Education Program. Dr. Davani is also editor and author of a recent book: "Pharmaceutical Analysis for Small Molecules", published by Wiley in 2017.


For Registration - https://www.complianceonline.com/pharma-analytical-method-validation-seminar-training-80595SEM-prdsm?channel=eventbrite

Note: Use coupon code REFERRAL10 and get 10% off on registration.

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Date and Time

Location

San Francisco

San Francisco, CA 94010-9949

View Map

Refund Policy

Refunds up to 30 days before event

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