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AVITSENA

Understand GMP inspections from both sides of the table. This course explains inspection principles, types and approaches, how inspectors think and how an inspection unfolds. You will design and run an effective self-inspection programme, report and score findings, and audit contract manufacturers, suppliers and API manufacturers. Dedicated modules cover the FDA approach and focus areas, preparing content and addressing known weaknesses, organisational preparation, behaviour and communication in the inspection room, handling observations and responses, and sustaining inspection readiness. A final assessment and a certificate of completion are included.

Turn audits from compliance policing into an engine for improvement. Learn layered audit programs, a one-page audit sheet, process mapping, root cause tools, waste spotting, success metrics and reports that get action.

التدقيق الرشيق — دورة فيديو تفاعلية بتعليق صوتي إنجليزي ونصوص ثنائية اللغة (إنجليزي / عربي).

Course modules

  1. Audits That Add Value
  2. Building a Layered Audit Program
  3. The Eight-Box Audit Sheet
  4. Mapping the Process: SIPOC and VSM
  5. Finding Root Causes
  6. Seeing Waste and the Vital Few
  7. Measuring Audit Success
  8. Lean Audit Reports and Sustaining the Program

Instructor: Rafat Alghubari — GxPeria Founder & MD.

For education only — always follow the official guidance and your site procedures.