LEF’s experience in several areas as led to a body of knowledge which we share with our clients and partners, supporting the implementation and management of Quality Systems, including customized training sessions.
- Quality Systems Development, in accordance with GMP, GLP, GDO, ISO 17025 and ISO 9001 requirements;
- Preparation for regulatory inspections and clients audits;
- Development of customized training programs (GXP and ISO standards);
- Internal audits for GMP, GLP, GDO and ISO regulations compliance;
- APIs’ Suppliers, finish product manufacturers, excipients manufacturers and packaging materials suppliers audits according to:
- Consultancy for validation (cleaning, manufacturing processes and analytical methods);
- Preparing the Site Master File and other GXP documents.