Your event should be here ! To publish, manage, promote... To learn or to be formed ... Online registrations

Site language : English - Français
Ref : 33402
Event :Analytical Method Validation, Verification and Transfer

Dates :Wednesday December 08th, 2021 - Thursday December 09th, 2021

Location :San Jose, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

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.

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


 

Program

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: 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(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

Speakers

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.


 

Organizing committee

Complianceonline
 

Location

Map and directions
Conference address :
San Jose
United States
Map and directions

Further information

To access the information you need to be connected. Creating an account is easy and free!

Log to your account
Register on Doctorama

Details

Analytical Method Validation, Verification and Transfer Pharmacy
pharma analytical method validation, analytical method verification, analytical method transfer, analytical procedure life cycle, validation procedures, compendial procedures, transfer of analytical procedure, drug approval process
Professionals
-- -- --
--

Other

For more information on Analytical Method Validation, Verification and Transfer, plsase contactr ComplianceOnline

To display announcer website, obtain a letter of invitation, you must be logged

Log to my account
Register on Doctorama


Recommend this event