Course "A Risk Based Strategy for the Development & Validation of Analytical Methods with a QbD Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Following the initial development, the steps further continues thru optimization and subsequently to Validation, leading to the understanding of Validation Parameters and their generic definitions. Guidance from EP, USP, ICH Q2 (R)1, AOAC etc. will be discussed. The presentation continually builds on from a conceptual level to practical applications leading to data handling, Data Integrity, Validation Protocol and other documentation, vis-a-vis Regulatory requirements. Discussions provide extensive guidance for preparing Methods Validation Protocols for the various stages of regulatory submissions, e.g. IND, NDA, ANDA, PAI, CMC etc. Various aspects of Laboratory Controls (CGMP), QC procedures, SOPs that cover calibration, standardization, Qualification and Validation, will be included, along with statistical tools, SQC, SPC for processing and monitoring of analytical data. Strategies for the development Stability indicating assays will be touched along with a discussion on Methods Transfer, Spec setting, QC Batch Release, Potency Assays etc.
Why you should attend:
"For various Analytical and Test Methods, a goal oriented pathway with proper design prior to development activities will help build Quality into the Method from the inception (QbD) and Validation helps to demonstrate that the desired Method is Fit For The Purpose. A Risk based strategy is needed to Develop and apply them for their intended purpose during the entire Life Cycle of such Methods" This presentation follows a progressive, time tested structure over the duration of 2 Days with a Breakout session for 2andHalf Hours on the 2nd Day, which involves Group participation ,with real analytical problem solving and Method Development and generate an appropriate Validation schematics and the Validation Protocol.
(From ACS site) Learn the fundamentals of quality assurance, quality control, and analytical methods validation and how to improve your FDA, WHO and OECD regulatory compliance directives for analytical data submissions.
Areas Covered in the Session:
- An overview of global compliance issues, global harmonization initiatives, role of ICH, relevance of Validation activities & the Paradigm Shift
- Quality Control and Quality Assurance in Analytical, R&D, QC, PD laboratories: General considerations, Quality Systems, QC procedures, QA oversight, Process Control Measure.
- Perspectives of ICH, ISO Integration: ICH Q1 (Stability Studies), Q2 (Analytical Methods), Q3 (Impurities), Q7 (Pharma Process), Q9 (Risk Assessment), Q10 (Quality Systems), etc.
- Measurement, Measurement Uncertainty, Measurement Resolution, Total Error, Bias
- Analytical Measurement: Process Model & Risk Assessment (REMS) in Methods Dev.
- A generic, science based outline of Methods Development & Validation [ab initio]
- Perspectives of QbD, PAT directives: online measurements /offline and the Paradigm Shift.
- Validation Parameters, their generic definitions and their practical applications.
- Highlights of the guidelines derived from International Standards - ISO 17025, AOAC, WHO, GLP, GMP, EMEA, USP/EP/JP, etc.
- Standardization/Qualification/Verification/Validation: the implicit continuum
- The challenges in Methods Transfer, the premise of Co- Qualification.
- Some case histories and applications for improvement of Validation characteristics
- Data integrity and statistical evaluation of analytical data: SQC, control charts etc.
- 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.
- Phase Appropriate Validation & Regulatory submissions: IND/ ANDA/ NDA/ CMC.
- Preparation for Regulatory Inspections from FDA, EMA, WHO, ANVISA, etc,
Who will benefit:
- R&D Personnel
- Quality Assurance / Quality Control Staff
- Validation Managers
- Validation Coordinators
- Production and Process Development Personnel
- Regulatory/Compliance Managers
- Technicians Study Directors(GLP)
- Qualified Persons (EMEA)
- Pharmaceutical Development
- CRO Staff
- CRO Managers
- Accredited Laboratories in general, any one engaged with Test Methods.
Day 1 Schedule
- Quality Systems, Paradigm Shift, Global Perspectives
- QA/QC Validation, Laboratory Controls
(Sections I & II)
- Risk Assessment, Strategy & Process Model
- Measurement Resolution, Errors and
(Sections III & IV)
- Rationale of Methods Development and Validation, A Generic Approach
- Guidelines of Method Development, Optimization and Validation Approaches [ab initio]
- Generic Definitions: Validation Parameters
(Sections VI & VII)
Day 2 Schedule
Review of Parameters, Axioms & General Practices
- Validation Guidelines: ICH, USP, Eurachem, AOAC, ISO 17025
- (CONT.) Validation Guidelines: ICH, USP, Eurachem, AOAC, ISO 17025
Class Breakout Discussion - Group Exercise
- Regulatory & Data Requirements
- Optimization and Validation in HPLC
(Sections IX & X)
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Senior Director, ValQual International
Shib Mookherjea is a globally acclaimed speaker and consultant and has extensive experience in R&D, quality assurance, and quality management and teaches Methods Development, Validation Procedures, and Conformity Assessment in the Analytical Laboratory; Qualification and Validation of Laboratory Instruments and Equipment for Regulatory and QS Compliance (IQ, OQ, PQ); and the webcast Cleaning Validation and Compliance Issues for Pharma, Biotech and Medical Device Industries.
Location: Baltimore, MD Hotel: The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum, MD 21090