Staff Augmentation by MPECT

• Implement cGxP/Quality Management System Requirement – MPECT staff can assist organizations in attaining certification to ISO 9000 and related management standards such as ISO 13485, AS9100, and ISO 1400, as well as compliance to FDA QSR 21CFR820.
• Support Validation & Qualification Activities – MPECT staff helps & assists clients with their .validation and qualification of systems & processes. We can support clients with needs in Validation, Infrastructure Qualification, CSV project management, system development, SOP development, Manufacturing Equipment Qualification and Process Systems (C&Q).
• Support Maturity Assessment -- The current control environment is compared against the MPECT control objectives to determine the maturity of the control.
• Support FDA GMP internal and supplier audits – MPECT provides auditing support to medical device, pharmaceutical, biological, tobacco, and other FDA monitored manufacturers & distributors. We can assist organizations achieve certification and compliance to internationally recognized standards and global regulations such as ISO 13485, FDA QSR, and European Medical Device Directives.
• Support FDA Remediation Management – warning letters, 483, consent decrees– MPECT has qualified professionals in the US, Europe, South America and Asia. We can provide immediate support to your quality team through staff augmentation.
• FDA RA/QA Training – With over 200 Qualified professionals located globally we can assist you with developing and/or providing GxP regulatory courses.