Two Day Virtual Analytical Method Validation, Verification and Transfer Training Course: November 8-9, 2021 - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Analytical Method Validation, Verification and Transfer Training" training 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, 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.

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/gz61rr

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
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