Fast track and risk based planning for an upcoming FDA Inspection
Review and close out of open issues
Facility set up and organization of records
Personnel training on inspection management, best practices on how to work with investigators
Guidance and support during an on-site FDA Inspection
Timely remediation and close out of 483's
QUALITY PLANNING, QUALITY MANAGEMENT SYSTEM DESIGN AND IMPLEMENTATION
Align quality objectives and metrics to support organizational goals and regulatory requirements
Develop and document procedures, work instructions and records in compliance to 21CFR820 and ISO 13485:2016
Establish robust Documents and Records Control processes, provide remote document control function
Provide Quality System Requirements training and ongoing quality audits
MANAGEMENT CONTROLS
Define organizational structure that supports business goals and regulatory compliance
Determine roles and responsibilities, and document personnel job descriptions
Assess business performance indicators, establish quality objectives that translate into methods and procedures
Set up data collection systems and procedures for reporting and monitoring of quality metrics and data analysis
Develop framework for Management Reviews that drive continuous improvement and facilitate effective communication on performance of your Quality system
Implement an effective internal Quality Audits System
CAPA SYSTEM AND COMPLAINT HANDLING
Establish a close-loop FDA compliant CAPA process
Review and close out of open CAPA's, management of your CAPA system
Develop a compliant Customer Feedback and Complaints process, Establish and maintain Complaint Files
Review and close out of open customer complaints
Develop a part 803 compliant Medical Device Reporting process, Audit MDR records, electronic submission of MDRs
Develop a part 806 compliant Corrections & Removals procedures
Document and train on Health Hazard Evaluation (HHE) procedures
DESIGN CONTROLS
Establish Design Control procedures
Audit documented product requirements against regulation and applicable standards
Provide guidance on compliant documentation of Design Inputs, Design Outputs, Design Verification and Design Validation
Plan, execute and document Design Transfer activities
Conduct and document Risk Analyses
Define requirements for and organize a Design History File (DHF)
PROCESS VALIDATION AND PRODUCTION CONTROLS
Review product and component specification for manufacturability and compliance with applicable regulations, ensure adequate documentation
Define Process Validation requirements and document a Process Validation Master Plan (PVMP).
Assist in documentation and execution of required Process Validation Protocols and Reports (IQ, OQ, PQ)
Set up processes and document control plans and procedures for robust IMTE and Acceptance activities
