The Annex 1 Revision: How Do You Implement a CCS on the Floor?
The new Annex 1 puts the contamination control strategy (CCS) at the centre. Seven points to watch when implementing it on the shop floor.
Read MoreInspection experiences, regulatory changes and industry perspectives. Not generic articles — content that has been thought through.
The new Annex 1 puts the contamination control strategy (CCS) at the centre. Seven points to watch when implementing it on the shop floor.
Read MoreThe most frequently recurring findings in EXCiPACT audits and recommended preventive actions.
Read MoreA checklist to quickly verify ALCOA+ compliance in production, laboratory and quality processes.
Read MoreMaximum Allowable Carryover calculation, choosing between swab and rinse, and the sampling plan.
Read MoreThe value of simulating an authority inspection and the key components of an effective mock audit.
Read MoreWhat SOPs that fail in practice have in common, and constructive ways to fix them.
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