Category:Regulatory

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The healthcare industry is surrounded by rules, standards and regulations such as GxP, ICH, 21 CFR Part 11 compliance, validation, version control, process management and continuous improvement processes. We are also regulated on all aspects of submission related activities including interactions with health authorities (FDA, EMA, MHLW etc), site inspections and audits. This category invites you to share your experiences and have open discussions on how best to work in such a highly regulated industry.

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