Validation of the pharmaceutical analysis method in 2 days,

Dublin, Nov. 18, 2022 (GLOBE NEWSWIRE) — The “Validation, verification and transfer of analytical methods” training has been added to from offer.

Reliable analytical results are needed to make informed decisions about product quality and safety in the pharmaceutical industry. Additionally, this analytical data is required for regulatory submissions in support of pharmaceutical product registrations. Therefore, meaningful experimental designs, including system suitability parameters, should be planned for the intended use of the procedure.

In this course, general guidelines for determining analytical characteristics for different types of validation procedures are highlighted for drug substance and drug product analysis. Factors to consider for verification of compendial procedures will also be discussed.

In addition, different approaches for transferring an analytical procedure from one laboratory (transfer) to another laboratory (receiver) under different circumstances will be covered. Other topics related to obtaining reliable data will also be discussed. These topics include qualification of analytical instruments as well as how to define, manage and monitor specifications.

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

Learning objectives

  • Drug approval process and regulatory requirements (private standards)
  • Pharmacopoeias and compendial approval process (public standards)
  • Pharmacy harmonization process
  • Chromatography System Suitability Requirements
  • Allowed Adjustments to Chromatography System Parameters
  • Analytical instrument qualifications including DQ, IQ, OQ, PQ
  • Validation of analytical methods
  • Verification of the analytical method
  • Analytical method transfer
  • Alternative to the 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 should attend:

  • Contract Laboratories (CRO)
  • Academia (pharmacy, pharmaceutical industry, pharmaceutical, chemistry)
  • Government (FDA or regulatory authorities)
  • Quality Analysis Managers and Staff
  • Staff control
  • Analytical and/or formulation chemists
  • Quality control managers and staff
  • Laboratory supervisors and managers
  • Pharmacy connections
  • Senior or graduate students (chemistry, pharmaceutical, pharmacy)
  • Pharmaceutical Scientists/Pharmacists Working in Industry

Main topics covered:

DAY 01

  • Review of seminar objectives, expectations and scope.
  • Drug Approval Process and Regulatory (FDA) Requirements (Private Standards)
  • Pharmacopoeia and Pharmacy (USP) Approval Process (Public Standards)
  • Pharmacy harmonization process
  • Chromatography System Suitability Requirements
  • Allowed Adjustments to Chromatography System Parameters
  • Analytical Instrument Qualifications
  • Instrument Categories
  • Qualification phases (DQ, IQ, OQ, PQ)
  • Analytical method validation (typical validation parameters)
  • Specificity
  • Precision/accuracy
  • Linearity/Range
  • LODs and LQs
  • Verification of the analytical method
  • FDA and USP requirements
  • Factors to consider
  • Analytical method transfer
  • Different approaches
  • Summary and Review

DAY 02

  • Life cycle of the investigation procedure
    • Tuning specifications FDA regulations and ICH guidelines (Q6A)
    • Out of Specification (OOS)
    • Out of trend (OOT)
    • How to manage OOS and OOT?
  • Summary and Review

For more information on this training, visit