The state of control regarding our cleaning processes is a constant issue by our regulators. Beyond purely “compliance” issues, it is a major point for control of the manufacturing process. This course is intended for manufacturers of final dosage pharmaceuticals, active pharmaceutical ingredients, and intermediates, as well as for biotech companies and R&D. This course is constantly updated according to state of the art and the changing CGMP expectations, focused on the aspects of technical and regulatory (US and EU) updates associated with validation of cleaning processes. Update are performed also according to guidelines or other important texts (PDA, ISPE, APIC, etc.). This course proposes deep details for all part of the global cleaning validation strategy in pharmaceutical activities. Biotechnology activities are also treated. Using examples and practical exercises, linking together techniques, quality assurance and compliance with FDA/EU requirements. At each step, the regulations are recalled and interpreted into operational and achievable recommendations.
At the end of this course the participants will have acquired the knowledge necessary for the rational and compliant implementation of a cleaning validation program for manufacturing equipment on pharmaceutical, cosmetic, biotechnology or chemical sites, from clinical to manufacturing batches.
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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