Reliable analytical results are necessary to make informed decision about the quality and safety of the products in the pharmaceutical industry. In addition, such analytical data are required for regulatory submissions in support of the drug product registrations. Therefore, meaningful experimental designs including system suitability parameters must be planned for the intended use of the procedure.

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 procedure from 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.

Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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)

Course Background:

This course is based on a recent book entitled "Pharmaceutical Analysis for Small Molecules" by Dr. Davani which was published by Wiley in 2017. In addition, examples and case studies will be provided based on insights and extensive experience in developing and implementing these topics in industry/pharmacopeia. Guidance and advice will also be provided based on interactions with global pharmaceutical industry, FDA and other regulatory authorities worldwide

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Day 01(8:30 AM - 4:30 PM)
  • 8:30 AM - 8:59 AM: Registration and Meet & Greet.
  • 9:00 AM - 10:00 AM:
    • Seminar objectives review, expectations and scope.
    • Drug Approval Process and Regulatory (FDA) Requirements (private standards)
    • Pharmacopeias and Compendial (USP) Approval Process (public standards)
  • 10:00 AM - 11:00 AM:
    • Compendial Harmonization Process
    • Chromatography System Suitability Requirements
    • Allowed Adjustments of Chromatographic System Parameters
  • 11:00 AM - 12:00 Noon:
    • Analytical Instrument Qualifications
    • Instrument Categories
    • Qualification Phases (DQ, IQ, OQ, PQ)
  • 12:00 Noon - 1:00 PM: Lunch
  • 1:00 PM - 2:00 PM:
    • Analytical Method Validation (typical validation parameters)
    • Specificity
    • Precision/Accuracy
    • Linearity/Range
    • LOD and LOQ
  • 2:00 PM - 3:00 PM:
    • Analytical Method Verification
    • FDA and USP Requirements
    • Factors to Consider
  • 3:00 PM - 4:00 PM:
    • Analytical Method Transfer
    • Different Approaches
  • 4:00 PM - 4:30 PM:
    • Summary and Review
Day 02(8:30 AM - 12:00 PM)
  • 8:30 AM - 8:59 AM: Registration and Meet & Greet.
  • 9:00 AM - 10:00 AM: Analytical Procedure Life Cycle
  • 10:00 AM - 11:30 AM:
    • Setting Specifications FDA regulations and ICH guidelines (Q6A)
    • Out-of-Specification (OOS)
    • Out of Trend (OOT)
    • How to handle OOS and OOT?
  • 11:30 AM - 12:00 Noon: Summary and Review
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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.

Prior to forming his own consulting company in 2017, he worked at USP for 17 years in different capacities including Director of Chemical Medicine Department and the Principal Scientific Liaison. His last responsibly at USP was the scientific management of the content development and teaching of USP Education courses for stakeholders worldwide. He was also a faculty for several Pharmacopeial Education courses both domestic and internationally. These topics include validation/verification/transfer of analytical procedures, impurities in drug substances and drug products, compendial HPLC, residual solvents, spectroscopy and stability studies for pharmaceutical products. In addition, he provided scientific support to the USP International Regulatory Affairs Department and Global Public Health Department for outreach and training for international regulatory agencies. Before joining USP in 1999, Dr. Davani worked in industry in various technical management positions for more than ten years.

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