Webinar GDP for APIs
Course No 17903
Important: Deadline is 12 noon on 30 September 2020
If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Speakers
Dr Nicola Spiggelkötter, Knowledge & Support
Background
Since September 2015, the “Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use” have been obligatory. The driving force behind these Guidelines is the combat against falsified drug substances and drug products. It is intended to control the entire supply chain and thus to mitigate the risk associated with complex distribution pathways. Well trained staff has to ensure that all the requirements of the guidelines are met. In several sections of the Guidelines, it is pointed out that a thorough training of the employees is important.
Target Group
This webinar is designed for all persons from companies involved in the distribution and supply of APIs. Those are e.g. coworkers and high-level personnel from the following industries:
- API manufacturers
- API distributors and traders
- Pharmaceutical manufacturers
- Logistics companies
- External warehouses
- further service providers offering services for the distribution of APIs
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.
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
This webinar aims to give participants a comprehensive yet compact overview of current expectations concerning GDP for APIs.
The topics addressed are:
- Regulatory requirements and guidance
- “Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use”
- “WHO Good trade and distribution practices for pharmaceutical starting materials”
- Ensuring compliance with the current requirements
- EU GDP for finished medicinal products and EU GDP for APIs: Similarities and differences
- Critical evaluation of individual aspects with regard to GDP for APIs
- Outlook: Where is the trend heading?
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity