Understanding the regulations leads to implementation and, ultimately, both internal and external audits of facilities against them. We believe in convergence of audit techniques to ensure that effort is concentrated toward overall audit success. We also believe in preparedness, ensuring facilities are at peak at all times. This means that should audits be required at short notice the facility can rest assured that it is ready. Our training covers a wide range of issues, each detailed and enjoyable. Each are built around your specific situation, bringing reality and focus to every session. Courses are structured to your requirement.
- The FDA & Other Audit A to Z.
- Audit Approaches
- Audit Routes & Routine
- Specific Audit CheckPoints, for example
- Organisation, Role & Responsibilities, Records
- Methods, Specifications, Testing, Approval & Release
- Raw Materials, Certification and Acceptance
- Processing & Process Control, NDA/DMF Comparisons
- Equipment, Utilities, Design & 'Fit for Purpose'
- Complaint & 'Outside Acceptance' Criteria. Annual Report.
- Materials, Packaging, Labelling, Storage & Designations
- Documentation Linkages & 'Fit for Purpose' & Deviation Systems
- Basically, we cover all the requirements. We hope to cover all the 'TrapDoors'.
Contact us with your specific requirements.