A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach 2018

Topics

• 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

Who should Attend

• 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