Dr. Raphael Bar
BR Consulting
Referent:innen
Dr. Thomas Backensfeld
Berlin
Dr. Bernd Renger
Bernd Renger Consulting
Dr. Sue Mann
Sue Mann Consultancy
Dr. Thomas Fürst
Boehringer Ingelheim
All times mentioned are CEST.
Zielsetzung
This Live Online Training will give a comprehensive overview of the main GMP requirements for Quality Control Laboratories, from a European as well as from the U.S. (FDA) perspective. It is the aim of the training to address the challenges that QC Compliance Managers face today regarding the relevant regulatory requirements and how to successfully implement these requirements in the analytical lab
Hintergrund
Due to changing regulatory requirements pharmaceutical Quality Control Compliance Managers are continuously facing new challenges. There are many regulatory requirements relevant for the pharmaceutical quality control, both in EU and in the U.S., for instance:
- EU GMP Guide (Part 1 / Part 2 / Annexes)
- 21 CFR Part 210/211 (USA)
- Guidances (EMA and FDA)
- ICH Guidelines
- WHO and PIC/S Recommendations
- Pharmacopoeias (Ph.Eur., USP)
QC Compliance Managers need to be familiar with all these GMP-related topics and need to be aware of the latest updates and the current interpretation of all these guidance documents.
In addition, analytical QC laboratories are increasingly in the focus of GMP inspections, both in Europe and in the U.S. For instance after FDA inspections, many laboratory-specific citations can be found in 483s and Warning Letters. And many findings related to the laboratory can also be found after inspections of European GMP supervisory authorities. Key compliance requirements include:
In addition, analytical QC laboratories are increasingly in the focus of GMP inspections, both in Europe and in the U.S. For instance after FDA inspections, many laboratory-specific citations can be found in 483s and Warning Letters. And many findings related to the laboratory can also be found after inspections of European GMP supervisory authorities. Key compliance requirements include:
- Change control Systems
- Calibration and qualification of analytical Instrument
- Reference Standards
- GMP compliant documentation
- Validation of analytical methods
- Stability program
- Laboratory Data Integrity
- Procedures for handling OOS results
All these key compliance issues will be addressed in this Live Online Training. A set of live Q&A sessions will give you the possibility to interact with the speakers and get answers to your Questions.
Please note that the emphasis of this training is on small-molecule pharmaceuticals. The course will not focus on biotech products.
Please note that the emphasis of this training is on small-molecule pharmaceuticals. The course will not focus on biotech products.
Zielgruppe
This Live Online Training will be of significant value to
- Laboratory managers
- Quality control managers
- Analytical scientists
- Senior laboratory staff
from Quality Control units in the pharmaceutical industry who are responsible for GMP Compliance in the Analytical Laboratory.
Technical Requirements
We use WebEx Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Regulatory Requirements for Analytical Labs and QC (EU and US)
- EU GMP Guide Part 1
- EU GMP Guide Part 2
- US 21 CFR Part 210/211
- FDA Guidances for Industry with relevance for labs
- Inspection of analytical labs (EMA, FDA, etc.)
- FDA Warning Letters relating to QC
Handling and Qualification of Primary and Secondary Chromatographic Reference Standards
- Procedure for qualification of a primary reference Standard
- Procedure for qualification of a secondary reference Standard
- Pharmacopeial standards: handling and re-use
- Will the certified reference standards (CRM) come to the QC lab?
- Assigning purity values to reference standards
- Calculation examples of assigning purity
Analytical Instrument Qualification
- USP General Chapter <1058> Analytical Instrument Qualification
- Risk Analysis
- Qualification steps: DQ/IQ/OQ/PQ
- Practical Qualification of typical instruments such as
- Balances
- HPLC
- UV
- Dissolution
Lifecycle Approach to Analytical Procedures
- Developing robust, stability indicating methods
- Analytical Target Profile
- Implementation of QbD in development of analytical methods
- Life-cycle of an analytical method
- Are we estimating the real method precision?
- The concept of Assay Format
Transfer of Analytical Methods
- Definition and regulatory requirements
- How to perform a method transfer
- Case studies
- Typical and critical issues
Presenting and Evaluating Stability Data
- Overview of ICH storage programs for new drugs
- Generic drugs
- Presenting stability data
- Derivation of shelf life according to ICH Q1E
Sampling of Packaging Components, Devices and Finished Products / Sampling of Raw Materials
- What is acceptance sampling?
- Sampling attributes vs. sampling by variables
- ISO 2859-1 sampling standard
- Nonconforming items and non-conformities
- Risks of sampling
- Sampling of starting materials (WHO standard)
- Full testing vs. testing for identity
Workshop on Sampling with ISO 2859-1
Managing Out of Specification and Out of Trend Results
- OOS / OOE / OOT
- FDA and MHRA Guidance
- Reportable Value
- Case Study: Practical approach for handling OOS results
- Issues with OOT results and how to manage these
Documentation in QC Laboratories
Regulatory requirements (EU/US)
- Specifications, Test Procedures, SOPs, etc.
- Handling of data (paper, electronic, hybrid)
- Laboratory Data Integrity
- Analytical results (Raw data, Raw data check, averaging, rounding of results)
- Case Studies
- Laboratory Data Integrity issues related to documentation - issues to be aware of
Analytical Aspects of Laboratory Data Integrity
- Overview of deficiencies in laboratory data Integrity
- Structure of a typical assay in a QC laboratory
- When system suitability requirements are not met
- Is there a system suitability test based on samples?
- When sample variability criteria are not met
- QC samples for method validity check
- Integration of chromatographic Peaks
- Reprocessing of raw data and re-integration
- Review of audit trail of an analytical run
QA Aspects in QC (relevant for QC Compliance Managers)
- Defining responsibilities for analysts, head of analytical lab, QPs (EU and US)
- Release of APIS, excipients, packaging materials, finished products, etc.
- Contract labs
- CAPA (Corrective Actions and Preventive Actions)
- Change Control (regulatory framework)
- PQR
- Training (GMP training / training on the job, training records)
| ECA-Member*: | € 1690,- |
| Non ECA Member*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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