FDA regulations skills matrix template

Overview Copied

A skills matrix template is a tool that organizations can use to effectively manage and assess the skills and certification statuses of individual employees or teams.

For example, you can use this FDA regulations skills matrix to pinpoint employees’ specific competencies and certification statuses in areas such as regulatory affairs, document control, and quality management systems for medical manufacturing.

• Certified FDA Compliance Specialist
• Certified FDA Quality Systems Auditor
• Certified FDA Regulatory Affairs Professional
• Certified FDA GMP (Good Manufacturing Practices) Expert
• Certified FDA Quality Control Inspector
• Certified FDA Validation Specialist
• Certified FDA Clinical Research Coordinator
• Certified FDA Medical Device Auditor
• Certified FDA Drug Approval Specialist
• Certified FDA Regulatory Compliance Manager
• Certified FDA Quality Assurance Manager
• Certified FDA Documentation Control Specialist
• Certified FDA Labeling Specialist
• Certified FDA Adverse Event Reporting Specialist
• Certified FDA Corrective and Preventive Actions (CAPA) Coordinator
• Certified FDA Quality Risk Management Expert
• Certified FDA Inspection Readiness Professional
• Certified FDA Supplier Qualification Specialist
• Certified FDA Clinical Trial Investigator
• Certified FDA Combination Product Expert

Related skills Copied

• Regulatory Compliance: Knowledge and understanding of the FDA regulations applicable to various industries, such as pharmaceuticals, medical devices, food and beverages, cosmetics, and dietary supplements. This includes regulations related to product safety, labeling, manufacturing processes, quality control, and post-market surveillance. Certifications like the Regulatory Affairs Certification (RAC) or the Certified Quality Auditor (CQA) validate expertise in FDA regulatory compliance.
• Good Manufacturing Practices (GMP): Proficiency in implementing and maintaining GMP standards to ensure the quality, safety, and consistency of regulated products. This includes adherence to guidelines for facility design, equipment qualification, process validation, documentation practices, and quality systems. Certifications such as the ASQ Certified Pharmaceutical GMP Professional (CPGP) or the ISPE GMP Professional Certification demonstrate knowledge of GMP regulations.
• Quality Management Systems: Skills in developing and managing quality management systems (QMS) compliant with FDA regulations, including the design and implementation of quality processes, procedures, and controls. This involves establishing a robust document control system, conducting internal audits, and managing corrective and preventive actions (CAPA). Certifications like the ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) or the ISO 9001 Lead Auditor validate proficiency in QMS for FDA-regulated industries.
• Adverse Event Reporting: Competence in the reporting and management of adverse events, including adverse drug reactions, product complaints, and safety incidents. This involves understanding the requirements for timely and accurate reporting, documentation, and communication with regulatory authorities. Certifications such as the Regulatory Affairs Certification (RAC) or the Certified Quality Auditor (CQA) demonstrate knowledge of adverse event reporting in compliance with FDA regulations.
• Clinical trial oversight: Competencies related to clinical trial conduct and oversight, such as Good Clinical Practice (GCP).
• Regulatory Inspections and Audits: Familiarity with the FDA inspection process and the ability to prepare for and facilitate regulatory audits. This includes understanding inspection protocols, responding to observations and findings, and implementing corrective actions. Certifications like the Regulatory Affairs Certification (RAC) or the Certified Quality Auditor (CQA) validate skills in managing regulatory inspections and audits.
• Validation and qualification: Expertise in validating equipment, systems, and processes in compliance with FDA regulations.
• Electronic record keeping: Tracking skills and certifications related to electronic records and signatures necessary for industries governed by FDA regulations.

Benefits Copied

Using a FDA regulations skills matrix can benefit your teams in various ways – especially if used with AG5’s skills management software. Our platform has several features built specifically to meet FDA requirements. They include:

• Audit trails. We automatically timestamp and document the history of all data changed – so you can meet the FDA requirements for accurate record-keeping and data traceability.
• Data management approvals. Establish multi-person workflow approvals for confirming and updating production records – so you can meet FDA requirements for data accuracy and change management.
• Data authorization. Set up two-factor authentication for approvals and data updates to ensure data integrity and enhanced access controls.

Frequently asked question Copied

Author Copied

Wais

With a decade of experience, Wais leads our Customer Success team, providing exceptional customer experiences at AG5. Find him cooking a feast or hosting his podcasts in his spare time.