Event description
Being a vendor to the pharmaceutical Industry can be a tough challenge. The industry is heavily regulated by authorities, and regulation has a huge impact on how the industry set the requirements for vendors of process and utility systems.
This course is designed to give vendors an understanding of the needs of the pharmaceutical industry and the regulations they are up against. It will equip vendors with knowledge and tools to ensure success by delivering services and products in an efficient way, which is satisfactory to both the vendor and the pharma company.
The course will also address the new trends of ASTM E2500, in which vendor documentation will serve as basis for qualification/validation practices, and look at how these opportunities will intensify the industry’s hunt for good and trusted vendors.
The course will primarily be based on case studies and examples from projects which NNE Pharmaplan has been responsible for worldwide.
Course outline:
- Background for the pharmaceutical industry’s requirements to vendors
- How to deal with the new trends outlined in the new ASTM E2500 standard
- Outline of the requirements to vendors:
- Quality systems
- Technical capability
- Documentation practice
- Engineering practice
- How to communicate with a pharmaceutical company
- How to test deliverables to ensure they meet the pharmaceutical company's expectation
Training material (handouts, notes and examples) and certificates for participation will be provided.
Who should attend?
The course is relevant for supervisors, technicians, sales people and managers who work in companies that deliver (or intend to deliver) systems/equipment/HW/SW for the pharmaceutical, device and biotech industries, in particular:
- Engineering personnel and managers
- Technicians and testing personnel
- Sales people
- Operations managers and quality engineers/quality controlling
When: 9.00 - 16.00 on Thursday 27 September 2012
Where: NNE Pharmaplan's headquarters, Nybrovej 80, Copenhagen (Gentofte)
Contact person: Brian Evald Andreasen
Price: DKK 4,000 per person
Duration: 1 full day
If you have any questions please contact Brian Evald Andreasen at BNAN@nnepharmaplan.com or on +45 3075 1381.
Registration
To register for the course, please fill in the form below. You will receive a confirmation and payment details on email. Note, that your registration is not final until we receive your payment.
Registration closes three days prior to the event or when the maximum number of participants (60) has been reached.