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Tag: FDA audit readiness

Quality System Regulation & QMS Compliance – XPRO AMERICA


Posted on August 22, 2025 | Posted on admin | Leave a Comment on Quality System Regulation & QMS Compliance – XPRO AMERICA

Compliance with the FDA Quality System Regulation (QSR / 21 CFR Part 820) is critical for medical device manufacturers to ensure product safety, effectiveness, and regulatory adherence. The QSR outlines…

| Tagged 21 CFR Part 820, corrective and preventive actions, device quality management, FDA audit readiness, FDA inspection preparation, FDA QMS implementation, FDA quality standards, FDA regulatory guidance, internal audits CAPA, ISO 13485 harmonization, medical device CAPA support, medical device compliance, medical device quality system, QMS documentation, QMS gap analysis, QMS record management, QSR compliance, regulatory compliance consulting, XPRO America QMS services

FDA cGMP Compliance & 21 CFR 210/211 Audit Support – XPRO America


Posted on August 21, 2025 | Posted on admin | Leave a Comment on FDA cGMP Compliance & 21 CFR 210/211 Audit Support – XPRO America

Compliance with Current Good Manufacturing Practices (cGMP) is mandatory for all pharmaceutical manufacturers, repackers, relabelers, and distributors who want to market drug products in the United States. Governed under 21…

| Tagged 21 CFR 210, 21 CFR 211, cGMP compliance, cGMP quality system, cGMP training support, drug manufacturing compliance, drug quality control FDA, FDA audit readiness, FDA batch record compliance, FDA cGMP audits, FDA compliance consulting, FDA GMP inspection support, FDA manufacturing standards, FDA pharmaceutical audits, GMP documentation review, GMP gap analysis, GMP record keeping, pharmaceutical GMP compliance, XPRO America GMP services

Recent Posts

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  • Premarket Approval (PMA) Applications for Class III Devices – XPRO AMERICA

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