Brandon Clapp

Background

About Brandon Clapp

Leadership | Cross-Functional Collaboration | Project Management | Remote Team Management A strong foundation in Quality Assurance and Regulatory affairs and a proven track record in regulatory compliance, project management, and conducting effective CAPA investigations to improve processes resulting in increased safety and customer satisfaction. Now transitioning into cybersecurity with a unique perspective able to align compliance with business objectives. Expertise in cGMP, CFRs, and ISO Standards, as well as championing cybersecurity risk and compliance standards within regulated industries will provide immediate value to the organization. Refined ability to propose solutions that meet Quality and Regulatory requirements into processes to ensure alignment with business objectives and cost considerations to ensure regulatory expectations are met that drive business success. CAREER HIGHLIGHTS: Risk based CAPA process architect resulting in a substantial reduction in open investigations and driving the business to focus on the right problems. Remediated Quality processes ensuring compliance with FDA and EUMDR regulations resulting in lower to no audit observations. Expert in ISO Standards, CFRs, and cybersecurity practices, ensuring Quality and Regulatory compliance for processes as well as device modifications. Expert in remediation techniques to improve processes and fix Quality Management Systems. Expert risk based thinking techniques to contain significant product/quality problems to ensure safety. SPECALITIES: CAPA | CFR 820.100 | Quality Assurance | Regulatory Affairs | FDA Regulations | ISO Standards | Risk Management | Compliance Audits | Quality Management Systems | EUMDR | MDSAP | Data Analytics |Technical Writing | Change Management | Root Cause Analysis | ISO 13485 | ISO 14971 | ISO 9001 | Supplier Management | Internal and External Audits | FDA Warning Letter Resolution | Continuous Improvement | Root Cause Analysis | Change Management | Procedural Technical Writing | Documentation Review | Documentation Management Systems | Security+| Network+| CySA+| Project+| ISC(2) SSCP | ITIL Foundation | Network Administration | Firewall Management | Windows Administration | MacOS Administration | Linux Administration | Python | Visual Basic