DUBLIN–(BUSINESS WIRE)–The “Analytical Method Validation, Verification and Transfer” 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
Who Should Attend:
Contract Laboratories (CRO)
Academia (pharmacy, Pharmaceutical Industry, Pharmaceutical, Chemistry)
Government (FDA or regulatory authorities)
Quality Analysis Managers and Personnel
Controlling Personnel
Analytical and or Formulation Chemists
Quality Control Managers and Personnel
Lab Supervisors and Managers
Compendial Liaisons
Senior or Graduate students (chemistry, pharmaceutical, pharmacy)
Pharmaceutical scientists/Pharmacists working in Industry
Key Topics Covered:
DAY 01
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
Investigative 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/lf88xx
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
[email protected]
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