A TO Z OF ANALYTICAL METHOD VALIDATION, VERIFICATION AND TRANSFER 2022
A TO Z OF ANALYTICAL METHOD VALIDATION, VERIFICATION AND TRANSFER
Dates: JULY 21 - 22, 2022
Time (Eastern Time US): 10 AM to 3 PM
Time (Central Europe): 4 PM to 9 PM
Duration: 2 DAYS
Course Director: KELLY THOMAS
ABOUT THE COURSE
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.
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.
SEMINAR 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 SHOULD ATTEND
- 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)
09:00 AM - 02:00 PM
Day 1
SESSION 1:
- Seminar objectives review, expectations and scope.
- Drug Approval Process and Regulatory (FDA) Requirements (private standards)
- Pharmacopeias and Compendial (USP) Approval Process (public standards)
SESSION 2:
- Compendial Harmonization Process
- Chromatography System Suitability Requirements
- Allowed Adjustments of Chromatographic System Parameters
SESSION 3:
- Analytical Instrument Qualifications
- Instrument Categories
- Qualification Phases (DQ, IQ, OQ, PQ)
SESSION 4:
- Analytical Method Validation (typical validation parameters)
- Specificity
- Precision/Accuracy
- Linearity/Range
- LOD and LOQ
09:00 AM - 02:00 PM
Day 2
SESSION 5:
- Analytical Method Verification
- FDA and USP Requirements
- Factors to Consider
SESSION 6:
- Analytical Method Transfer
- Different Approaches
SESSION 7:
- Analytical Procedure Life Cycle
SESSION 8:
- Setting Specifications FDA regulations and ICH guidelines (Q6A)
- Out-of-Specification (OOS)
- Out of Trend (OOT)
- How to handle OOS and OOT?
SESSION 9:
- Summary, Review and Q&A Session
