DUBLIN–(BUSINESS WIRE)–The “Analytical Method Validation, Verification and Transfer Course” training has been added to ResearchAndMarkets.com’s offering.
Reliable analytical results are necessary to make informed decisions 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, a 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 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 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
Key Topics Covered:
DAY 01 (10:00 AM – 4:00 PM EST)
- Seminar objectives review, expectations and scope.
- Drug Approval Process and Regulatory (FDA) Requirements (private standards)
- Pharmacopeias and Compendial (USP) Approval Process (public standards)
- Compendial Harmonization Process
- Chromatography System Suitability Requirements
- Allowed Adjustments of Chromatographic System Parameters
- Analytical Instrument Qualifications
- Instrument Categories
- Qualification Phases (DQ, IQ, OQ, PQ)
- Analytical Method Validation (typical validation parameters)
- Specificity
- Precision/Accuracy
- Linearity/Range
- LOD and LOQ
- Analytical Method Verification
- FDA and USP Requirements
- Factors to Consider
- Analytical Method Transfer
- Different Approaches
- Summary and Review
DAY 02 (10:00 AM – 01:00 PM EST)
- Analytical Procedure Life Cycle
- Setting Specifications FDA regulations and ICH guidelines (Q6A)
- Out-of-Specification (OOS)
- Out of Trend (OOT)
- How to handle OOS and OOT?
- Summary and Review
For more information about this training visit https://www.researchandmarkets.com/r/xec598
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