Robert T. Vidile Ii Email & Phone Number

A company dedicated to client's establishment of / or improvements in business profitability, operation, and compliance. Specializing in FDA and ISO Management System regulations and standards; Quality Systems, Quality Assurance, Quality Control for non-regulated and regulated businesses interested in improvement or assistance with Regulatory Action abatement. Services include: Management Supplementation, Process and Procedure Development, Training, Assessments, Compliance Evaluations / Auditing, Mentoring, Consulting, and Coaching.

Participate as a Nonconformance and CAPA SME in the Company Quality System Conformity Assessment and Enhancement Project

Provide QMS guidance and CAPA backlog reduction and remediation support.

Provided QMS guidance for Complaint Management, CAPA, and data analysis to assure complained to CFR 21 Parts 820 and 4.

Established Quality System Manual, Design Control, Complaint, and Documentation Management processes to comply with CFR 21 Part 820 supporting FDA EUA submission.

Audited /Assessed and provided feedback in response to customer audit request against subparts of CFR 21 Part 820 for material receiving, control, handling, identification, storage, protection, nonconformance management, packaging, labeling, and distribution.

Audited /Assessed and provided feedback and recommendations in response to an FDA Warning Letter commitment. Assessed were Management Responsibility, Complaint Management, Medical Device Reporting, Corrections and Recalls, Supplier Management, Purchasing Controls, Calibration, Test Method Validation, Servicing, Change Management, and Training.

Principle Consultant – and Management System construction levels towards MDSAP compliance; remediated Quality System Manual based on assessment findings and alignment to corporate requirements; created an EU MDR 2017/745 Gap Assessment tool.

Audited and provided feedback / remediation recommendations for Supplier, Purchasing, Internal Quality Audit, Process Development, Nonconformance, Complaint, and CAPA systems and records.

Remediated current CAPA and CAPA related procedures for compliance to FDA CFR21 Part 820.100 CAPA Regulations and associated ISO13485:2016 Clauses. Revised procedures to close compliance gaps and complete system, prepared and delivered training to staff.

Assessed current CAPA and CAPA related procedures and practices for compliance to FDA CFR21 Part 820.90 Control of Non-conforming Product and Part 820.100 CAPA Regulations and associated ISO13485:2016 Clauses. Focus was on nonconformance identification, assessment and CAPA escalation requirements. Provided recommendations for compliance gap closure, procedures and practice appropriate for business model. Provider of diagnostic systems and accessories for the diabetes market

Assessed current CAPA and CAPA related procedures for compliance to FDA CFR21 Part 820.100 CAPA Regulations and ISO13485:2016. Reviewed and provided feedback on a sample of completed CAPA records. Provided recommendations for compliance gap closure, procedures and practice appropriate for business model.

Guided / Developed Combination Product QMS Requirements to comply with FDA CFR21 Part 4 Combination Device Regulations (introduce requirements from Part 820), ISO13485:2016, ICH-Q10 and EU/MDR in the Management Responsibility, CAPA, Complaint Management, Continuous Improvement, Training, Internal Audit, and Medical Device Reporting arenas, Provided interpretation of global device compliance requirements for combination products for staff, identified Metrics for monitoring and continuous improvement of those processes, Identified industry best practices for client consideration and process enhancement.

Guided / Assisted in response resolution ISO Registrar Observations for CAPA and Management Responsibilities. Assisted in CAPA record progress.

Provided guidance and assistance in preparing responses to the FDA's 483 observations.

CAPA Workstream Lead – CAPA System Procedures and Record Remediation and Improvement / CAPA System re-engineering, Mentor and Train Senior Management and staff on CAPA process execution and related QMS elements. Performed gap assessments, identified solutions, remediated current CAPA / CAPA records and associated CAPA procedures to close identified gaps and align with company profile and resource capability.

Created a Quality Management System to support manufacturing operations at a current medical device distribution center. Worked with Device Manufacturer Quality and Distribution management and on site staff to understand current operations and procedures and scale a system that met their current and future needs.

Train and mentor staff on overall CAPA process execution; manage/oversee the CAPA function. Provide investigation training and critique investigations, Action and Effectiveness Plans. Develop CAPA metrics and reports to Management. Work with CAPA and Workstream Owners on Management System CAPAs towards Management System remediation and FDA/ISO Compliance.

Perform FDA QSR compliance assessment and recommend solutions to close gaps identified.

Performed compliance assessments for FDA 483 Observation CAPAs, assembled and organized Objective Evidence.

Assess and remediate CAPA records, mentor CAPA Owners, Quality Approvers in compliant effective CAPA execution towards driving CAPAs to successful problem elimination.

Evaluated Process and Equipment Validation records against regulatory and company requirements.

Perform Design Control and other QMS audits as assigned. Assist client with remediation of findings from 3rd party assessor.

Execute CAPAs in conjunction with client CAPA Owners and process needs. Recommend Containment and Corrections, lead and conduct investigations for Root Cause, recommend and implement Corrective Actions and Effectiveness checks; follow through to collection of all Objective Evidence and Summary reporting on behalf of client CAPA Owners. Assist client in CAPA process improvements towards compliant and efficient use of the CAPA System; assist in alignment for migration to an eCAPA System.Revised Current CAPA Process to address identified execution challenges and align with North American operations. Developed a specific CAPA process to align with QMS Remediation project needs.

Consulting, developing, and providing services to companies seeking establishment of / or improvements in Management and Quality Systems, Quality Assurance, Quality Control, FDA Regulatory and ISO Management System compliance.

Leading a team of CA/PA Analysts to reduce backlog and remediate remaining CA/PA records on file.Establishing a scaled CA/PA System from Analysis of Quality Data through to Management Reporting.Developing Guidance documents for Quality Data Sources, Analysis, Statistical Techniques, Metrics and Key Process Indicators.Training Management and staff on CA/PA expectations and requirements.Training and mentoring CA/PA Review Board and CA/PA Owners on Containment, Investigation Methods, Correction and Corrective Action development and Effectiveness Checks.Driving forward movement of CA/PAs through to closure. Transitioning the developed system to internal owners for execution and sustainability.

Princeton, New Jersey, Us

Trained Executive Management, Management and Staff on Nonconformance and CA/PA Management regulations, requirements and expectations. Provided feedback to management on current system performance. Conducted Gap Assessment on current process for alignment and function to meet current requirements and company goals. Mapped "As Defined" and "To Be" NC and CA/PA Management System and detailed procedural changes to satisfy compliance and alignment of processes.

Ann Arbor, Michigan, Us

Managed CA/PA System in place of permanent Manager in a Consent Decree environment; developed next generation CA/PA and Non-conformance management systems.Recruited and managed a group of 19; 7 permanent and 12 contract employees investigating both product and management system issues.Led development of both nonconformance and CA/PA processes to be compliant and align with company structure. Established a new CA/PA Review Board and Review Board management approach.

Baar, Zg, Ch

Establishing a scaled CAPA System from Quality Data Analysis through to Management Reporting.Developed Guidance documents for Quality Data Sources, Analysis, Statistical Techniques, Metrics and Key Process Indicators.Trained Management and staff on requirements in plain English terms.Trained and mentored CAPA Owners on Containment, Investigation Methods, Corrective Action development and Effectiveness Checks.Established a CAPA Review BoardDrove forward movement of CAPAs through to closure.

Kalamazoo, Mi, Us

Accountable for Divisional CAPA processes and effective correction of non-conformances and systemic system failures across five international sites.Managed a team of four CAPA Analysts, Quality System Project Manager all focused on non-conformance elimination, compliance gap closure, and process improvement. Drove two projects to reduce backlog of over 150 High Risk CAPAs to < 50 in 6 months and 500 Minor CAPAs to < 100 in 5 months. Identified weaknesses in current system at the root of the backlog, devised a corrective action plan to prevent repeat of the same.

Manage all Quality Operations including: Quality Assurance, Quality Engineering, Quality Control, and Documentation Management Functions. Support staff of fifteen individuals accountable for Management System Audit, Quality Engineering, Regulatory and Standards Compliance, Complaint Management, Product Quality and Documentation Management activities in support of assembly and distribution of metered dosage pumps for Pharmaceutical, Cosmetic and Perfumery markets. Accountable for Management System efficacy and compliance; representing company to Customers, FDA, and ISO Registrar during Certification and Surveillance Audits. Manage maintenance of Management System to meet business, regulatory, and compliance needs.

Stavanger, No

Managed for Quality Assurance, Compliance, Quality Engineering, and Quality Control Functions. Supported staff of four individuals accountable for Quality Assurance Engineering, Regulatory and Standards Compliance, Complaint Coordination, and Manufacturing Product Audit activities in support of assembly and distribution of pre-hospital healthcare devices and training products. Accountable for Management System efficacy and compliance; representing company to FDA and ISO registrar during routine surveillance audits. Managed maintenance of Management System to meet business, regulatory, and compliance needs.

New York, Us

Coordinate all business related issues between assigned Business Segment projects and Quality Assurance and Regulatory Group, worldwide; inclusive of new product development, existing product support, regulatory (FDA/EMC/IVD), safety (UL/CSA/CE), and standards engineering. Participated as Project Development Team Member managing development and commercialization of new products and existing product line extensions. Evaluated new product releases through audit and design review assessing compliance with company Quality System requirements, FDA Regulations, Worldwide Safety regulatory requirements, other government and governing directives; trained management, other team members and project engineers in methods used.

New York, Us

Conducted Operations Audits at various sites worldwide to Corporate, FDA GMP, and other US regulatory requirements.Evaluated companies targeted as strategic businesses partners and new suppliers of systems and products. Participated in new product development assessments and design reviews.

Us

Bs, Computer Information Systems

Aas, Electronics