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.
Drug Approval Process and Regulatory Requirements (private standards)
Pharmacopeias and Compendial Approval Process (public standards) Compendial Harmonization Process
Allowed Adjustments of Chromatographic System Parameters
Analytical Instrument Qualifications including DQ, IQ, OQ, PQ Analytical Method Verification
Alternative to Official procedure and options
How to Set Specifications and how to handle out-of-specification (OOS) and out-of-trend (OOT) results
Academia (pharmacy, Pharmaceutical Industry, Pharmaceutical, Chemistry)
Government (FDA or regulatory authorities)
Quality Analysis Managers and Personnel
Quality Control Managers and Personnel
Senior or Graduate students (chemistry, pharmaceutical, pharmacy) Pharmaceutical scientists/Pharmacists working in Industry
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
Allowed Adjustments of Chromatographic System Parameters
Analytical Method Validation (typical validation parameters)
Analytical Method Verification
Investigative Procedure Life Cycle
Setting Specifications FDA regulations and ICH guidelines (Q6A)
Out-of-Specification (OOS)
How to handle OOS and OOT?
For more information about this training visit https://www.researchandmarkets.com/r/lf88xx