Event description
The approach for achieving qualification and validation compliance in the pharmaceutical industry is changing these years. A more cost-effective way is possible after the release of the ASTM E2500 standard in 2007. Using the outlined science and risk-based approach can generate significant improvement of the quality assurance of processes and facilities and at the same time reduce effort, resources and time consumption.
This course presents an alternative to the historical V Model for qualification and validation using a lean, science and risk-based approach, based on the ASTM E2500 principles. The course is primarily based on case studies and examples from the ASTM E2500 projects NNE Pharmaplan has been responsible for worldwide.
Course outline:
- Differences between traditional commissioning and qualification and the ASTM E2500 approach
- How to use quality risk assessments (FMEA and HAZOP) as basis for:
- identifying critical aspects
- identifying design solutions and review item
- selecting vendors
- planning qualification (verification)
- How to plan, delegate responsibilities and define QA’s role in the E2500 setup
- How to handle vendors use their documentation as basis for qualification
Training material (handouts, notes and examples) and certificates for participation will be provided.
Who should attend?
The course is relevant for supervisors and managers who work within or are responsible for qualification, commissioning and validation in the pharmaceutical, device and biotech industries, in particular:
- Quality assurance/quality control personnel and managers
- Engineering personnel and managers
- Operations managers and quality engineers
- Validation personnel and managers
When: 9.00 - 16.00 on Thursday 13 September 2012
Where: NNE Pharmaplan's headquarters, Nybrovej 80, Copenhagen (Gentofte)
Contact person: Brian Evald Andreasen
Price: DKK 5,000 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. Please note that your registration is not final until we have received your payment.
Registration closes three days prior to the event or when the maximum number of participants (60) has been reached.