Reliable analytical results are necessary to make an 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, the 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 procedures from one lab (transferring) to another 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 the global nature of the 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 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

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 the global pharmaceutical industry, FDA, and other regulatory authorities worldwide

Session Agenda:-

DAY 01(9:00 AM - 4:00 PM EST)

• 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: Break
• 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(9:00 AM - 12:00 PM EST)

• 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

Who Should Attend:-

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)