A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach

A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach is a seminar that covers topics such as:

  • Quality Control and Quality Assurance in Analytical, R&D, QC, PD laboratories: General considerations, Quality Systems, QC procedures, QA oversight, Process Control Measure
  • An overview of global compliance issues, global harmonization initiatives, role of ICH, relevance of Validation activities & the Paradigm Shift
  • Measurement, Measurement Uncertainty, Measurement Resolution, Total Error, Bias
  • Perspectives of ICH, ISO Integration: ICH Q1 (Stability Studies), Q2 (Analytical Methods), Q3 (Impurities), Q7 (Pharma Process), Q9 (Risk Assessment), Q10 (Quality Systems), etc
  • A generic, science based outline of Methods Development & Validation [ab initio]
  • Analytical Measurement: Process Model & Risk Assessment (REMS) in Methods Dev
  • Validation Parameters, their generic definitions and their practical applications
  • Perspectives of QbD, PAT directives: online measurements /offline and the Paradigm Shift
  • Standardization/Qualification/Verification/Validation: the implicit continuum
  • Highlights of the guidelines derived from International Standards - ISO 17025, AOAC, WHO, GLP, GMP, EMEA, USP/EP/JP, etc
  • Some case histories and applications for improvement of Validation characteristics
  • The challenges in Methods Transfer, the premise of Co- Qualification
  • Methods Development and Optimization in HPLC, UV-VIS including assessment of Peak Purity, as examples of the most recent techniques widely used in analytical laboratories
  • Data integrity and statistical evaluation of analytical data: SQC, control charts etc
  • Preparation for Regulatory Inspections from FDA, EMA, WHO, ANVISA, etc
  • Phase Appropriate Validation & Regulatory submissions: IND/ ANDA/ NDA/ CMC

A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach brings together:

  • Managers
  • Scientists
  • Quality Assurance / Quality Control Staff
  • R&D Personnel
  • Validation Coordinators
  • Validation Managers
  • Regulatory/Compliance Managers
  • Production and Process Development Personnel
  • Technicians Study Directors(GLP)
  • Chemists
  • Pharmaceutical Development
  • Qualified Persons (EMEA)
  • CRO Managers
  • CRO Staff
  • Accredited Laboratories in general, any one engaged with Test Methods

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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