Ronan Boyle

• Process & Equipment Validation • Packaging Development & Validation • MDR Transition • CAPA Management • Validation Master Plan Development • Equipment Development • Process Development

Identifying & Assessing Unmet Needs, Concept Selection, Intellectual Property Strategy, Market Strategy, Financing, Operational Planning, Business Planning, Research & Development Strategy, Financial Modelling, Prototype Evaluation, Funding Applications, Industry Mentoring & Training

Project Management, Manufacturing Site Setup, Pharmaceutical Packaging Equipment Development, Serialization, Regulatory Compliance, Commissioning Qualification and Validation (CQV), Risk Management

Project Management, Risk Management, New Product Introduction (NPI), Technology Transfer, SAP Upgrade, Manufacturing Execution System (MES) Implementation, Packaging Design, Process Development, Process Validation, Design Control, Design Validation, DHF, Lean Sigma, Design for Manufacturability (DFM), CAPA Management, Unique Device Identification (UDI), Regulatory Compliance, Change Management

Packaging Equipment Development, Package Design for Combination Devices, New Package Introduction, Supplier Audit, Supplier Component Qualification, CAPA Management, Risk Management, Packaging Validation, Packaging Testing, Technology Transfer, Continuous Improvement

Process Development, New Product Introduction (NPI), Technology Transfer, Facility Setup, Process Validation, Risk Management