The Center for Professional Innovation & Education, Berlin, Germany
May 12 & 13, 2009
Who Should Attend This two day course is designed for those who perform, supervise, manage, audit, or oversee activities related to international pharmaceutical supply chain and/or cold chain distribution. This includes, but is not limited to: - QA, QC and Validation Staff
- Warehouse and Distribution Managers
- Customer Service Managers
- Regulatory/Compliance Managers
- Qualified Persons (EMEA)
- Distributors, Wholesalers and forwarders
- Procurement and Purchasing Managers
Learning Objectives
Upon completion of this course, attendees will have a clear understanding of the relationship between Good Distribution Practice directives and the design, qualification and management of the supply chain distribution processes. This course provides insight in how to design, qualify and maintain passive and active cold chain processes. Furthermore, the attendees will get a basic insight in Brand Protection and anti-counterfeiting developments.
Course Description
This course is a combination of classroom training, in which theories are presented, and workshops, which translate these theories into the practices that can be immediately implemented by all attendees. The course contains several case studies and examples of GDP and Cold Chain best practices. During the course relevant ICH Global Harmonization quality guidelines will be addressed. The attendees will learn how the quality system approach can result in an optimal state of control with respect to supply chain compliance and integrity. The participants will practice creation of a third party service provider audit program, as well as, developing pass-fail criteria for various aspects of the audit program
|
|