Who We Are

Comprised of a group of over forty senior quality, regulatory, operations and manufacturing professionals, Barile and Associates provides a broad range of support for the medical device, pharmaceutical, human tissue and biotechnology industries.

We have a great depth of technical expertise with capabilities in design and manufacturing engineering, science, statistics, quality systems, process design and validation, computer technology deployment and validation. We are experts in US FDA and international regulatory requirements. We have offices in North America, the Middle East, Asia and Europe.

Meet The Team

Expand all Collapse all
Michael Barile, Founder and Managing Partner

Mr. Barile has over thirty-five years of experience in the medical device, pharmaceutical, human tissue and biotechnology industries. He has held the executive quality assurance position in both start-up and large multi-national corporations, specializing in difficult turnaround situations. His depth of experience in both line and corporate management has given Mr. Barile a unique and practical hands-on expertise with a wide variety of challenges over a diverse range of product technologies.  A recognized expert in risk management, software and process validation, continuous improvement methods and quality systems, he lectures worldwide in seminars and for various trade groups.

Robert Humphrey, Senior Quality Engineering Consultant

Mr. Humphrey is an experienced engineer with over twenty years of experience in design verification & validation, test engineering and quality engineering. Amongst his accomplishments, Mr. Humphrey has designed and implemented test methodologies for new products that have reduced both cost and time to market, developed company wide policies and procedures to ensure compliance to cGMPs, QSRs, ISO 60601 and ISO-9001/9001-3 requirements and devised metrics to evaluate software development and verification efforts. Mr Humphrey is also an Instructor at the University of Phoenix in the school of Business and Technology and at Lake Washington Technical College in the Information Technology / Computer Applications Department.

Andrew Snow, Senior Engineering Consultant

Mr. Snow has over twenty five years of experience managing quality, design and development for large medical device companies, start-ups and as a contract manufacturer. He has proven expertise in quality systems, risk management, design controls, requirements management, software life cycle processes and reliability engineering. Mr. Snow has developed risk management processes for software and hardware based medical devices using ISO 14971 and has leveraged this expertise to help companies improve compliance, product quality and reliability. He has also championed numerous lean and six sigma efforts to reduce cycle time and improve quality.

Dr. Rainer Boenigk, Senior Quality Assurance and Regulatory Affairs Consultant

Dr. Rainer Boenigk has over thirteen years of experience in medical devices, in-vitro-diagnostics and pharmaceuticals. Over the course of his career, Dr. Boenigk has been both Vice President of Quality and Regulatory Affairs at the executive management level with global responsibilities and as an individual contributor to various international quality assurance & regulatory affairs functions. He has also been a Plant Manager. Dr. Boenigk & acute areas of expertise include quality assurance, regulatory affairs, crisis and risk management, global FDA compliance, lean manufacturing of medical devices, pharmaceuticals (sterile fluids), in-vitro-diagnostics, electromechanical equipment and sterile/non-sterile consumables.

Dr. Christopher Gribbin, MD, Consulting Physician

Dr. Christopher Gribbin has over twenty five years as a practicing physician and expert in the field of Radiology. Dr. Gribbin is currently an Interventional and General Radiologist and Attending Radiologist at Robert Wood Johnson University Radiology and a Clinical Assistant Professor of Radiology, University of Medicine and Dentistry of New Jersey, RWJ Medical School. Dr. Gribbin has authored numerous medical publications, presented at conferences and is a member of six medical societies including the Society of Cardiovascular and Interventional Radiology.

James Carr, Senior Software Consultant

Mr. Carr provides a wide range of software services including: compliance auditing to US FDA 21 CFR parts 11, 210/211/820 and GAMP software validation guidelines; generation and execution of reasonable corrective action plans; development and deployment of complete software life-cycle quality systems; and the preparation of specific software deliverables such as user requirements specifications, program specifications, commented source code, validation plans, test cases, test reports, deviation analysis, traceability analysis, etc.  Mr Carr is also experienced with the preparation of risk assessments and software validation remediation plans and the performance of software related training programs.

Danielle Clay, PhD, MBA, Senior Quality Consultant

Dr. Clay is a highly motivated, detail oriented individual with over ten years of experience in FDA regulated environments. She is a remediation specialist, focusing on Design History files, CAPA documentation, risk management files, and validation documentation. Dr. Clay is an expert in statistical analysis and quality systems and in the interpretation of the requirements of 21 CFR Parts 820, 803 and 11. She has the ability to rapidly adapt to different organizations and re-prioritize workloads based on business needs. Dr. Clay has excellent communication skills.

Moshe Ytzhaik, Senior RA/QA Consultant and Director of Middle East Operations

Mr. Ytzhaik has over 20 years of experience managing quality operations, R&D and the supply chain for device and communications companies, from start-ups to large established organizations.  He has strong IT experience, having led many ERP and PDM implementations.  Mr. Ytzhaik earned a Master's of Business Administration degree from Bar-Ilan University and a Bachelolor of Science degree from Beer-Sheva University.

Ronald Eisenwinter, Senior RA/QA Consultant

Mr. Eisenwinter has over twenty years of diverse experience with pharmaceuticals, biologics, – in vitro – diagnostics, and medical devices in various worldwide operations ranging from start-ups to fortune 100 companies.  Mr. Eisenwinter is experienced in clinical trials management and oversight, and has drafted over 100 regulatory submissions (510(k), IDE, PMA, IND, BLA) with frequent FDA interaction.  He is also experienced in process and software validation, software training, QSr, GLP, GCP and cGMP auditing, SOP development, and general regulatory and QA consulting.

Dr. Terry Henry, Senior RA/QA Consultant

Dr. Henry has extensive experience in FDA regulated industries with a focus on API and dosage form development (pre-clinical, phase I/II/III, NDA), regulatory strategy, project management, quality assurance, validation, and manufacturing. She has a solid track record of successful drug approvals: pulmonary, anti-viral, pain management. Dr. Henry is highly skilled in leading, planning, communicating and deploying resources towards successful product approvals and launch in the US and internationally. She is also an excellent public speaker and trainer.

Thomas Iliadas, Senior Process Development and Validation Consultant

Mr. Iliadas has over twenty five  years of experience in the medical device, human tissue, biotechnology, and pharmaceutical industries. He has extensive hands-on experience in product and process development from concept through market launch. His expertise includes commercializing and validating new products and manufacturing technologies. Tom is the recipient of numerous corporate awards for engineering and quality excellence. His core competencies include Process & product development, process validation, design control, project management, and cost improvements.

William Jameson, Senior Operations Consultant

William Jameson is a senior technical program manager with over thirty five years of experience in both commercial and consulting environments. Mr. Jameson´s diverse background offers a transferrable understanding of what enables program success. Mr. Jameson´s manufacturing industry focus, with specific expertise in FDA regulated industries sector, compliments his dedication to commercializing and improving product designs and production processes. Mr. Jameson consistently delivers more accurate, reliable, and profitable processes and operations.

Karen Jones, Senior RA/QA Consultant

Ms. Jones has extensive experience in the pharmaceutical and human tissue processing industries.  She has facilitated numerous US FDA product submissions.  Ms. Jones is a cleaning and process validation expert and is experienced as well in the validation of production and laboratory software systems.  She has expertise in the microbiological control of production environments and equipment, has run microbiological laboratories and supervised production operations.

Kim (KC) Low, Senior QA/RA Consultant

Mr. Low has over seventeen years of experience within the medical device, pharmaceutical and biologics industries in the areas of Quality Assurance, Quality Control, Regulatory Affairs, and Clinical Affairs. He is an expert in the requirements of the QSR, cGMP, and GLP regulations as well as of ISO 13485. KC has been awarded over 12 patents and has 29 patents pending both in US and EU in biopolymer, biomaterials, protein, polyamino acid and polypeptides. He is an expert in process validation and stability studies and is also experienced in filing 510(K) submissions. Further, he is competent in SAP R/3 in both the Quality and Material Management Modules and has participated in the corresponding validations.

Ulf Lundgren, Senior RA/QA Consultant and Director of European Operations

With over 30 years of experience in Regulatory Affairs and Quality Assurance, Mr. Lundgren has developed a broad skill set including expertise in clinical trials, product registration, sterilization, laboratory controls, quality systems and the requirements of the US FDA regulations and the European MDD. Mr. Lundgren has established industry recognition and has participated in leadership positions of various industry committees.

David Manalan, Senior Quality and Compliance Consultant

Mr. Manalan is a strong individual contributor with over forty years of multi-disciplinary experience in FDA regulated industries. He is an expert in both the drug/biologics cGMPs and in the device QSRs and has developed and deployed systems that achieved sustainable compliance to these requirements. Mr. Manalan has also created and filed INDs, Drug/Device Master Files, BLAs, and 510(k)s and has demonstrated capabilities in both pre and post market regulatory compliance to provide a sustainable competitive advantage for clients.

Bill Miller, Senior Quality Consultant

Mr. Miller has a wide scope of quality management systems knowledge and the ability to initiate positive change. He is a savvy leader with the talent for proactively identifying and resolving problems, re-engineering quality system processes into sustainable operations and maximizing productivity. Mr. Miller has the ability to develop and lead high-performance cross-functional teams, build and maintain relationships and to ensure project deliverables are brought in on-time and within budget.

Oscar Rodriguez, Senior Process Development and Validation Consultant

Mr. Rodriguez has over 18 years of engineering experience in the medical device industry. He has hands-on experience with product and process development from concept through market release. He has developed and enhanced diverse manufacturing processes and has extensive experience with validation of processes and equipment.

Valerie Shupp, Senior Quality Engineer

Ms. Shupp is an experienced Quality Engineer with a detailed knowledge of the requirements associated with both US FDA 21CFR Part 820 and ISO 13485. Ms. Shupp area’s of expertise include: Software Validation, CAPA and Continuous Quality Improvement, Trend Analysis, Vendor Management, Regulatory Compliance and auditing.

Dr. Diane Sudduth, Senior RA/QA Consultant

Dr. Sudduth has in-depth experience working both within FDA and the industries the agency regulates. Responsibilities within industry have included regulatory submissions for a wide range of medical devices and pharmaceutical products; clinical study design; the complete development and deployment of Quality Systems as well as programs designed to ensure compliance with applicable regulatory requirements; provision of bio-statistical support, and supplier evaluation/certification.

Lewis Lee, Senior RA/QA Consultant and Director of Asia Operations

Mr. Lee is a senior professional with thirteen years of experience in establishing and managing QA and RA functions in the Asia Pacific Region for multi-national companies.  He is an expert in US FDA, China SFDA, the EU MDD and JPAL requirements as well as in sustainability compliance for medical device organizations. Also experienced in Lean Six Sigma methods, process validation, and ISO 14971 Risk Management methods, Mr. Lee is a thorough and well organized planner who communicates effectively in multiple languages.