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