Trevor Coomber
Pharmaceutical Development Consultant
Referent:innen
Dr. Xaver Schratt
GBA Pharma
Dr Christopher Burgess
Burgess Consultancy
Including Bioanalytical Procedure Performance Qualification, Measurement Uncertainty & ATP, and the latest USP & ICH developments
Zielgruppe
- Laboratory Managers, Supervisors and Analysts in Pharmaceutical quality control departments who have responsibility for the validation of analytical test procedures
- Personnel from Quality Assurance, Regulatory Affairs and Contract Laboratories
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.
- 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.
Programm
Validation in Context
- Practical components of data quality
- Assessment of data Quality
- Analytical Procedure Life Cycle 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 & Reportable Values
- Qualification, Calibration & Validation
- Measurement uncertainty
- Propagation of Errors
- Measurement uncertainty of a CRM
- Detection and quantitation Limits
- Noise & drift
- Statistical aspects
- What is a reportable value?
- Method performance and process capability
Analytical Procedure Life Cycle Management; the Future Direction
- Validation; the changing regulatory climate
- FDA Process Validation Paradigm shift
- Analytical Procedure Life Cycle 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 Life Cycle
- 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
Performance Qualification of Bioanalytical Procedures; Similarities and Differences
- What makes Bioassays special?
- Key aspects of USP <1030> and the biological assays Triage
- ICH Q2(R2) and USP <1033>
- Application of performance qualification acceptance criteria
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 Life Cycle 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.
Weitere Informationen
Venue
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona
Spain
+34 (93) 503 53 00
sants@barcelo.com
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona
Spain
+34 (93) 503 53 00
sants@barcelo.com
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT)
Non-ECA Members € 2,490
ECA Members € 2,290
APIC Members € 2,390
EU GMP Inspectorates € 1,245
The conference fee is payable in advance after receipt of invoice and includes social event on the first day, lunch on three days and all refreshments. VAT is reclaimable.
Non-ECA Members € 2,490
ECA Members € 2,290
APIC Members € 2,390
EU GMP Inspectorates € 1,245
The conference fee is payable in advance after receipt of invoice and includes social event on the first day, lunch on three days and all refreshments. VAT is reclaimable.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
The official conference language will be English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Manuela Luckhaupt, +49 (0)6221 84 44 66, luckhaupt@concept-heidelberg.de
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Manuela Luckhaupt, +49 (0)6221 84 44 66, luckhaupt@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 13 October 2026, 09:00-17:30 h
(Registration and coffee 08:30-09:00 h)
Wed, 14 October 2026, 08:30-17:30 h
Thu, 15 October 2026, 08:30-16:30 h
(Registration and coffee 08:30-09:00 h)
Wed, 14 October 2026, 08:30-17:30 h
Thu, 15 October 2026, 08:30-16:30 h
Teilnahmegebühr
| ECA-Member*: | € 2290,- |
| Non ECA Member*: | € 2490,- |
| EU/GMP Inspectorates*: | € 1245,- |
| APIC Member Discount*: | € 2390,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager"
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E-Mail: info@concept-heidelberg.de
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