Dublin, Nov. 01, 2021 (GLOBE NEWSWIRE) -- Final days to register for the "Analytical Method Validation, Verification and Transfer Training" training course has been added to ResearchAndMarkets.com's offering.
Reliable analytical results are necessary to make informed decision about the quality and safety of the products in the pharmaceutical industry.
In addition, suchanalytical dataare 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 ofvalidation proceduresis highlighted for the analysis of both the drug substance and drug product. The factors to consider for verification of thecompendial procedureswill 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 includeanalytical instrument qualificationas 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.
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
Key Topics Covered:
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 - 4:30PM:
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
For more information about this training visit https://www.researchandmarkets.com/r/ikifny
