Trevor Coomber
Pharmaceutical Development Consultant
Referent:innen
Dr. Xaver Schratt
GBA Pharma
Dr. Christopher Burgess
Burgess Analytical Consultancy
Zielsetzung
The objectives of this Education Course are
- to offer practical solutions for determining the validation characteristics
- to learn how to deal with measurement uncertainty and to understand its impact on analytical methods validation
- to understand the qualification of laboratory equipment as a precondition of reliable analytical testing
- to discuss the scope of qualification & validation necessary
- to obtain approval by the Registration Authorities (EMA, FDA, MHRA, etc.)
- to become familiar with the statistical parameters to be applied
- to outline the documentation (SOPs, Validation Protocols and Reports, etc.) which you should have in your lab.
- to provide an outline of the new USP & ICH developments of procedure validation
In order to improve the understanding and practical application of the contents of the lectures, workshops will be part of the training course.
Hintergrund
The ICH guideline Q2 lists all characteristics to be considered during validation and describes the method of determining the various validation characteristics. Reliable analytical results do not only require validated test procedures but also the use of analytical equipment qualified for its intended purpose. In order to obtain regulatory approval, the qualification of all critical laboratory equipment must be performed and documented ensuring “fitness for purpose”. Furthermore, measurement uncertainty is of key importance in analytical instruments qualification as well as in analytical methods validation and transfer. Therefore, it is absolutely essential that measurement uncertainty is well understood by everybody who is responsible for generating and evaluating analytical results in GMP controlled laboratories.
Zielgruppe
This interactive Education Course will be of particular interest to Laboratory Managers, Supervisors and Analysts in pharmaceutical quality control departments who have responsibility for the validation of analytical test procedures. Furthermore, this Course is designed for personnel from Quality Assurance, Regulatory Affairs and Contract Laboratories.
Programm
Gesamtes Programm als PDF herunterladen
Validation in Context
- Practical components of data quality
- Assessment of data Quality
- Analytical Procedure Lifecycle Management; the future direction
- Course road map
Basics of Measurement Uncertainty
- Why is measurement uncertainty important?
- Relationship between uncertainty and confidence
- Uncertainty of measurement
- What is a measurand
- Error sources in analysis and testing
Analytical Instrument Qualification
- USP <1058> Guidance
- USP revision process and GAMP
- Validation Master Plan
- Definition of DQ, IQ, OQ and PQ
- Examples of protocols and documents
- Change Control
- Risk assessment
Measurement Uncertainty in Calibration and Qualification of Analytical Instruments
- Qualification, Calibration & Validation
- Measurement uncertainty
- Propagation of Errors
- Measurement uncertainty of a CRM
- Detection and quantitation limits
- Noise & drift
- Statistical aspects
Analytical Procedure Lifecycle Management; the Future Direction
- Validation; the changing regulatory climate
- FDA Process Validation Paradigm shift
- Analytical Procedure Lifecycle Management
- Data governance in a regulated laboratory
- ICH Q12
- USP <1220>
- ECA APLM guideline
Statistical Aspects of Analytical Methods Validation
- The use (and misuse?) of statistics to support Validation data
- Basic theory of the common statistical techniques
- Merits, pitfalls and underlying assumptions of particular tests
- The meaning behind
- Standard deviation - F-test - t-test
- ANOVA
- Linear regression; Correlation Coefficient & Coefficient of Determination - Exploration of more sophisticated statistical techniques such as interval hypothesis testing and experimental design
Robustness and Ruggedness: the Pathway to System Suitability Tests
- Method development cycle
- Analytical process capability
- Selecting factors and levels
- HPLC experimental design example
- Impact on system suitability tests
Method Validation During the Development Lifecycle
- Product Development Life Cycle
- Sources of Guidance
- ICH Q14 Concept paper
- Screening and Early Safety Studies
- Phase 1 Volunteer Studies
- Phase 2 Clinical trials
- Towards MAA/NDA
Validation for MAA/NDA: Planning and Execution
- Analytical validation according to USP
- FDA Guidances for method validation
Validation for MAA/NDA: Documentation
- Validation report
- Transfer protocol/report
- Validation documentation for registration
- Validation software
- Other Sources of Guidance
Error Budgets and Reportable Values
- What is a reportable value?
- OOS, OOE & OOT
- Method performance and process capability
- ICH precision Approach
- Measurement Uncertainty approach combined sources of variation
Transfer of Analytical Test Procedures
- Statistical Tests
- Analytical significance vs statistical significance
- Acceptance criteria Setting
- Interval hypotheses
Comparison of the APLM and Current ICH & USP Approaches
- Traditional approach to analytical method (procedure) validation, verification and transfer
- ICH Q2
- USP <1225> & <1226> [& <1224>] - FDA process validation guidelines 2011
- USP initiatives: Application to analytical processes
- Proposed General Chapter <1220>
- Statistical toolbox for<1225>; General Chapter <1210>
- New ECA AQC Guideline
- Analytical Procedure Lifecycle Management
- New ICH initiatives
Workshops
During the Course, 4 workshops will be conducted in order to deepen the content of the lectures and to discuss practical
aspects in detail. Workshops will be offered on the following topics:
During the Course, 4 workshops will be conducted in order to deepen the content of the lectures and to discuss practical
aspects in detail. Workshops will be offered on the following topics:
Analytical Instrument Qualification
The participants will debate the impact of USP proposals in a practical context
Validation Plan
The participants will work on testing schedules for the relevant validation parameters.
Validation Documents Critique
The participants will work, in detail, on a typical case study proposing a suitable program of work for a validation dossier.
Method Transfer
The participants will discuss practical details of an Analytical Methods Transfer.
| ECA-Member*: | € 2090,- |
| Non ECA Member*: | € 2290,- |
| EU/GMP Inspectorates*: | € 1145,- |
| APIC Member Discount*: | € 2190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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