Staff Profiles

Vantage Consulting International, Ltd. consists of highly trained consultants with a broad range of experience and expertise. Their extensive regulatory and quality system knowledge of the medical device and pharmaceutical industries allows them to provide comprehensive solutions to any worldwide regulatory compliance need.

Vantage Consulting International also has access to many affiliated technical and support personnel to assist in large compliance resolution projects.

Michele Vovolka

Michele Vovolka, is the President of Vantage Consulting International, Ltd. She has over 27 years of quality, regulatory, customer service and project management experience with various divisions of Baxter Healthcare and Allegiance Healthcare. She has directed responsibilities in Medical Device Quality System Requirements (QSR), Design Control, Medical Device Reporting, Recall and Field Corrective Actions, Good Laboratory Practices, Premarket Notifications (510k), European Technical File, New Drug Applications, Investigational Device Exemptions, Quality Audits, Program Management and Customer Service operations.

She has been directly responsible for the implementation of multiple quality systems including the first Russian GMP compliant and ISO certified manufacturing operation. She has been directly responsible for the implementation of design control processes that resulted in the market introduction of over 850 new products within an 18-month period. Ms. Vovolka has a B.S. degree in Biochemistry and Chemistry. She is an ASQC Certified Quality Engineer and Certified Quality Auditor, and is also Regulatory Affairs Certified, (RAPS). She is a member of American Society of Quality Control, Regulatory Affairs Professional Society.

Jan Miller

Jan Miller, has over 39 years experience in the U.S. and International Healthcare industry. She has directed responsibilities in Medical Device Quality System Requirements (QSR), Design Control, Medical Device Reporting, Recall and Field Corrective Actions, Good Laboratory Practices, Premarket Notifications (510k), European Technical File, New Drug Applications, Investigational Device Exemptions, and Quality Audits at various divisions of Baxter Healthcare and Allegiance Healthcare. She assisted with the implementation of cGMP/ISO quality systems for first company inside Russia to obtain ISO certification. Ms. Miller has a B.A. in Business Management. She is Regulatory Affairs Certified, (RAPS) and is a Certified International Quality Assurance Lead Assessor, (IQA). She is a member of American Society of Quality Control (ASQC), Regulatory Affairs Professional Society (RAPS) and Future Business Leaders of America.

Chuck Smith

Chuck Smith, has over 29 years experience in manufacturing, quality assurance and regulatory compliance for both the drug and medical device healthcare industries. He has knowledge and expertise in the assessment and implementation of domestic and quality systems compliant with GMP, ISO 9000 and the European Medical Device Directive. He has extensive knowledge and experience in aseptic processing manufacturing techniques, controlled environment qualifications, process validations for both drug and device manufacturing processes, aseptic liquid and powder filling, and computer controlled lyophilization sytems. Mr. Smith is knowledgeable in the Drug GMPs, Medical Device Quality System Requirements (QSR), ISO 9000, Medical Device Reporting, Recall and Field Corrective Action, Good Laboratory Practices, Equipment Calibration and Design Control.

Michael Burnard

Michael Burnard has more than 35 years experience in the U.S. and international medical device industry. He has had direct management responsibilities for domestic and international quality operations. He has successfully managed FDA and European Notified Body audit. He is experienced in the conduct of quality system and regulatory compliance assessments of R&D, manufacturing, regulatory and suppliers to meet FDA, Canadian, European regulations and ISO. He has developed and implemented quality and regulatory standards and guidelines. He has also developed and conducted many training courses on quality system regulations (QSR), design control, process validations, ISO 13485, GMPs, good documentation practices, internal auditing and corrective and preventive actions. He is a Certified Quality Auditor (ASQ –CQA).

Mary Serio

Mary Serio has 20 years experience in manufacturing, quality assurance and regulatory compliance. She has participated on product submission teams to develop NDAs. Ms Serio developed and implemented quality standards and guidelines for research and development personnel. She is knowledgeable in the Drug GMPs and GLPs and has experience conducting GLP and GMP audits.

Helen Chandler

Helen Chandler has over 27 years of professional experience in quality engineering, quality assurance and regulatory compliance for the pharmaceutical, IV-D, and medical device healthcare industries. She has managed responsibilities according to Medical Device Quality System Regulation (QSR), ISO 9001, ISO 13485, and MDD 93/42 EEC in the following areas: quality engineering, supplier quality engineering, auditing, sterilization, environmental control, calibration, incoming quality assurance, corrective preventive action. Her experience also includes quality and process engineering in In-Vitro Diagnostics and Pharmaceuticals.

She specializes in process optimization and validation (including test method development) for both automated and non-automated processes including extensive experience in large ERP system software validation. Helen has been the quality representative on numerous design control teams, where she has acted as project leader, led teams in risk assessment and new product non-clinical validation activities. She is an experienced trainer in quality systems, process and software validation, statistical techniques, and team building. She has performed numerous audits internally, third party and with suppliers. Ms. Chandler has a B.S. in Chemical Engineering, and a B.S. in Biology. She is Regulatory Affairs Certified (RAPS) and is a Certified Quality Engineer (ASQ). She is a member of American Society for Quality (ASQ), Regulatory Affairs Professional Society (RAPS), and North Carolina Regulatory Affairs Forum (NCRAF).