FDA Inspections

Oct
21

Top 10 GMP Audit Failure Reasons: FDA and TGA Inspection Findings

Preparing for GMP/PICS Audits by TGA or FDA Inspectors can be a time for introspection. An upcoming GMP audit can even provide inspiration for initiating a continuous improvement initiative, perhaps discussed for months or years yet not yet implemented. So pre-audit preparation is all about focusing on actions, rather than endless discussions. Yet TGA and […]

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Sep
19

Industry Updates: PDA and FDA Joint Regulatory Conference

Our GMP courses, e-learning courses and GMP Forums repeatedly get great reviews by people who need to know the latest PDA and FDA information on regulatory requirements, compliance inspection findings, and GMP compliance audit trends…why is that the case? It’s because our GMP training course experts and quality/risk management compliance consultants regularly attend the top […]

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