Ronald Britt Email and Phone Number

Britt Pharma Consulting LLC provides consulting services to the pharmaceutical, biopharmaceutical and medical device industries, specializing in cGMP compliance, product quality and product failure investigations, compliance remediation, vendor selection and assessment, supplier oversight and quality agreements, R&D Quality Assurance, Quality by Design, and CMC Registration activities.

Senior Consultant, GMP SME, Confidential Pharmaceutical Client, San Diego, CA• Assisted virtual, late-stage pharmaceutical client with Pre-Approval Inspection readiness resulting in successful PAI outcome.• Performed cGMP compliance assessments of CAPAs, Change Controls, Deviations, Investigations and OOS documentation generated by client’s contract manufacturers (CMOs) for API, oral solid dosage forms and clinical kits, and recommended follow-up remediation and corrective actions.

Senior Consultant, GMP SME, Confidential Pharma Client, Yardley, PA Assessed Quality Management System and compliance needs of virtual specialty pharmaceutical client developing combination inhalation products and provided prioritized recommendations for improvements.• Developed QA and Clinical SOPs, Quality Manual and Quality Agreement template for contract manufacturing of inhalation device, API, drug formulation and contract packaging.

Senior Consultant, J & J McNeil Consumer Healthcare, Lancaster and Fort Washington, PA• Provided cGMP expert consulting services and coaching for consent decree remediation and sustainable process improvements of manufacturing, packaging, validation and facilities Quality System Elements (QSE). • Performed cGMP compliance GAP analyses and verified site SOPs, Change Controls, CAPAs and training met company Quality Standard requirements.

Reported to the CEO of MicroDose Therapeutx, a privately held specialty pharmaceutical company founded in 1998, pioneering the creation of superior next-generation inhalation products for unmet medical needs. Ensured quality of products and services met requirements, specifications and quality standards established by the company, clients, and regulatory agencies. Managed QA group and budget. Performed internal and external quality system audits. Interfaced with client companies and contractors. Developed and implemented quality metrics and benchmarks. Approved internal and contractor change controls, investigations, deviation reports,CAPA, Design History File documents, development plans, risk management plans, FMEAs, validation protocols, engineering drawings, technical reports; bioanalytical and clinical protocols and study reports. Led training and safety programs. Designed and implemented a business appropriate Quality Management system (QMS), document management system and Standard Operating Procedures (SOP’s), ensuring fast, flexible and compliant company services and product development processes. Developed, negotiated and implemented quality agreements with contract pharmaceutical and medical device CMOs, CROs and laboratories and provided quality oversight ensuring cGMP compliance and a sustained supply chain for clinical development programs. Prepared, reviewed and approved CMC sections for three IND filings for complex combination electronic Dry Powder Inhaler (DPI) drug products including: Drug Substance, Drug Product, excipients, container and closure system, clinical labeling, inhalation device design, development, manufacturing, operation and user manuals, which resulted in on-time FDA approval and initiation of successful clinical trials.

Reported to the CEO of MicroDose Technologies, Inc., a privately held R&D company founded in 1998, pioneering the development of proprietary drug delivery technologies. Ensured quality of products and services met requirements, specifications and quality standards established by the company, clients, and regulatory agencies. Managed QA group and budget. Performed internal and external cGMP quality system audits. Interfaced and collaborated with client companies and contractors. Developed and implemented quality metrics and benchmarks. Prepared, reviewed and approved CMC and clinical sections of IND submissions and IND annual reports. Approved internal and contractor change controls, investigations, deviation reports, CAPA, Design History File documents, development plans, risk management plans, FMEAs, validation protocols, engineering drawings, technical reports; bioanalytical and clinical protocols and study reports. Led training and safety programs. Established cost effective training programs for GXP compliance, Medical Device Design Control, laboratory operations and safety and environmental programs, ensuring a skilled, motivated, compliant staff. Implemented cost effective equipment calibration program ensuring data integrity and regulatory compliance. Implemented Chemical Hygiene Plan, Hazard Communication Program and hazardous waste management program ensuring compliance with OSHA and EPA Regulations.

• Analyzed laboratory investigations (LI), categorized root causes of OOS for drug eluting Cypher stent device and delivered actionable report for reducing incidence of LI to QA management of client Cordis Corporation.

Responsible for assessment, investigation and resolution of complex cGMP compliance issues, including manufacturing deviations, product testing and stability OOS failures, consumer complaints, supplier non-conformances and CAPA. Supported FDA inspections, PAI preparation, NDA Field Alerts, and product recalls. Accountable for driving quality improvements through internal and external audits, identifying corrective actions, CAPA, and participating on continuous improvement, gap analysis, customer service and new product launch teams.

Provided leadership, coaching and vision for newly formed, empowered Team of 10 Quality Control professionals, responsible for cGMP batch release testing for active ingredients and finished products and implementation of supply chain management initiatives.

Represented Chemical Operations department on clinical development projects and new product launch teams. Prepared CMC chemistry sections for IND, NDA, and SNDA filings. Coordinated registration activities and resolved supply chain issues resulting from changes in externally supplied active pharmaceutical ingredients. Prepared GMP training modules. Provided technical support to Active Pharmaceutical Ingredient (API) manufacturing. Led risk analysis teams. Ensured compliance with environmental regulations. Validated pharmaceutical active ingredient manufacturing processes within target budget and timelines, ensuring compliance with FDA regulatory requirements.

Accountable for preparation and administration of $14M budget and capital appropriations, coordination of departmental performance evaluations and salary administration, and departmental monthly report. As Deputy Director, represented department on divisional management, operations, safety and quality GMP committees. Managed 125-person department during 1.5 year vacancy of Executive Director position and received Business Excellence award for outstanding performance and leadership. Led Active Pharmaceutical Ingredient (API) Facility Task Force. Performed site evaluations and cost analysis. Represented Pharmaceutical Division at meetings with state and local officials. Presented recommendations and investment proposal to senior management.