The objective of this training is to present reference practices in the qualification of equipment, as well as the metrological aspects associated to the Pharmaceutical industry, and will have trainers Manuel Bernardo (EIA) Ricardo Girão and Tiago Pires (TELSTAR).
The Qualification of Equipment and Systems is an integral part of Good Manufacturing Practices for the Pharmaceutical Industry. Meeting this requirement adequately with available resources and the risks to processes and products remains a challenge for companies.
Associated with the Qualification, are obviously all the Metrological aspects of the equipment, which are fundamental to ensure. The effective integration of Qualification and Metrology is an essential factor for professionals in this sector.
Check out the Program:
- General concepts
- Regulatory references - GMP (new Annex 15 EU cGMP)
- Impact assessment
- Equipment to qualify
- Extension of qualification
- Qualifying Phases
- URS
- Design Qualification
- Installation Qualification
- Operational Qualification
- Performance Rating
- Qualification of Systems in Use
- Revision of Qualifications and Requalifications
- Practical examples
- Autoclaves
- Climate Cameras / Storage Areas
- Clean Rooms
- Introduction to Metrology
- Applicable terminology
- The Uncertainties of Measurements
- Certificate Analysis
- Acceptance Criteria
- Rules for approval or qualification of equipment.
Registration is limited and can be made by email to cila.silva@relacre.pt. The values of this training are:
Partner RELACRE € 120,00 + VAT
Not Partner € 160,00 + VAT