Qualification of Classified Areas Training

Periodic requalification of your cleanrooms is a mandatory step in demonstrating to the regulatory authorities that cleanliness classes are being robustly maintained.
This service is very often subcontracted; the aim of this course is to present the regulatory requirements and the associated standards.
The purpose is to make it easier for you to work with the reports submitted during audits and to enable you to give a clear, precise and documented presentation of external HVAC requalification files.

TRAINING OBJECTIVES
> Master the standards:
- Presentation of the specific standards (ISO 14644, 14698 and 17141 series) and reference texts (§ 4.23 to 4.32, EU GMP Annex 1 in force)
- Checking that the report content complies with the normative requirements (number of points, sampling volume, positioning, calculation, etc.)
- Focus on specific, critical points such as particle counting, filtration (Class G / F / E / H / U), HEPA filter integrity, tests and target values for RH, ΔP, unidirectional airflow, recovery time back to class, differential pressures between areas, mastering the information shown on a particle count printout, raw data traceability, calibration of measuring instruments, corrected values, analysing microbiological results, assessing contamination risks from smoke study results

> Master non-conformance management:
- Approach conformities/non-conformities with an informed eye.

> Assess the clarity of qualification reports
- Every service provider has its own presentation format; how to harmonise them.

Target audience:
Operator, technician, quality

Experience level:
Beginner, intermediate, expert

Duration:
One-day session (adaptable for customised modules)

Accessibility for people with disabilities:
Please contact us if you require disability accommodations