Live Online Training - Stability Testing for Biological/Biotechnological Drug Substances and Drug Products
Objectives
- the basic requirements of stability testing and stability study design from the supervisory authority’s view
- the peculiarities of stability indicating analytical methods
- optimising strategies regarding packaging and storage of biological/biotechnological material
- how to submit stability data for a marketing authorisation dossier according to the new Guideline on Quality Documentation
Background
The evaluation of stability may necessitate complex analytical methodologies. Appropriate physicochemical, biochemical and immunochemical methods for the analysis of the molecular entity and the quantitative detection of degradation products should also be part of the stability program.
In order to get the approval to conduct a clinical trial data have to be presented on the biological, chemical and pharmaceutical quality of Investigational Medicinal Product (IMP). In the new Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials particular provisions are laid down on how to document stability and other quality related data within the CTD structure.
Target Group
- Manufacturing process professionals
- QA/QC staff and regulatory personnel
- Clinical staff, pharmacologists and toxicologists
- Project Managers & outsourcing personnel
- Analytical chemists and biochemists
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programme
Seminar Programme as PDF
- Biologicals and relevant guidelines
- Specific differences between chemical entities and biologicals
- Stability-indicating profile of Monoclonal Antibodies and Immunoglobulins
- Storage conditions
- Impact of changes on stability
- Submitting stability data within the CTD-structure
- Prerequisites for performing a stab study
- Concepts for study design and reporting
- Start, study performance and study closing
- Regulatory aspects during product development
- Objectives for a final stab study report
- Selection of appropriate, sensitive methods
- Analysis of stressed samples
- Statistical interpretation of shifts and drifts
- Acceptance limits
Degradation of Polysorbate
- Mechanisms of Polysorbate degradation
- Consequences of Polysorbate degradation
- Analytical tool box for degradation assessment
- Control of excipients
- Specifications, batch analysis
- Stability data
- Shelf-life determination
- Post approval extension
- Substantial amendments
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more
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Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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Seminar Programme as PDF
