Expert Details
Quality System & Regulatory Compliance, Life Sciences, Re-Engineering, 21 CFR Part 11
ID: 724419
Arizona, USA
Expert is a Certified Quality Auditor and has audited medical device companies, contract manufacturers, suppliers, and distributors. She has over 16 years experience auditing and has conducted audits based on ISO 9001:2000, ISO 13485:2003, ISO 14971:2007, cGMP's, 21 CFR Part 820, 21 CFR Part 11, MDD, CMDR, and IVDD. She has successfully established and managed Internal Audit programs for over 20 medical device and diagnostic companies.
As a seasoned Quality Professional, she has applied gap analysis to most areas of the services she offers. She has provided over 35 gap analysis reports to clients as a result of business and quality assessments. She utilizes gap analysis at the beginning of a project engagement to set a clear roadmap for success. She also utilizes gap analysis prior to any system rollout to ensure all the gaps have been closed.
She has served as an expert quality system and regulatory compliance consultant for small start-up companies as well as large global organizations.She has successfully established and implemented world-wide quality system training programs ranging from foundational to advanced courses supporting cGMPs, US FDA regulations, ISO standards, and European Medical Device Directives.She has successfully led large, complex, global business and quality system re-engineering projects. She has provided expert end-to-end Project Management for the implementation of automated business systems through Off-The-Shelve software applications, including software selection, configuration, data migration, system integration, and validation. Expert has conducted numerous quality system and regulatory compliance audits and assessments for clients around the globe.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1987 | Degree: BA | Subject: Philosophy | Institution: Bridgewater College |
| Year: 1989 | Degree: Graduate Coursework | Subject: Philosophy | Institution: The George Washington University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2006 to Present | Employer: Undisclosed | Title: Owner/Principal Consultant | Department: Undisclosed |
Responsibilities:Expert provides quality system & regulatory compliance services to the Life Sciences Industry including:Project Management, Quality System design & deployment, Quality System gap analysis & re-engineering, Quality System & compliance assessments, Internal Quality Audit programs & management, Supplier Quality Audit programs & management, FDA QSIT, ISO 13485, ISO 9001 assessments & audit preparation, MDD, IVDD, CMDR, and FDA Part11 assessments & audit preparation, FDA Facility Registration assistance, Customized Training programs, instructional design, and delivery, Document and Change Control business systems, Data & Records Management business systems, Design Control strategies & assistance, Process Validation programs & assistance, Software Validation programs & assistance, CAPA programs & management, Complaint Management & Vigilance Reporting, Recall & Field Correction assistance, Nonconforming Material programs & management She offers comprehensive project management services combined with quality system/regulatory compliance leadership for the creation and implementation of individualized business focused quality systems, including any configuration and implementation of software solutions to support those business processes. Expert provides complete assessment and audit reports including detailed recommendations for system improvement, ways to reduce regulatory risk, and business efficiency based on industry best practices. She partners with clients to develop software validation requirements that ensure compliance with Part 11 when automating business and quality systems. She supports clients in defining system requirements, preparing Requests for Proposals & Quotes (RFP & RFQ), and selecting appropriate software applications to meet individual compliance needs and business goals. She provides instructional design and delivery of a wide variety of quality system training courses designed specifically for audiences ranging from the executive board room to manufacturing operators/technicians to field service personnel. She develops and authors standard operating procedures to support business processes tailored to the needs of individual clients. |
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| Years | Employer | Title | Department |
| Years: 2001 to 2005 | Employer: Undisclosed | Title: Director of Quality Assurance | Department: Undisclosed |
Responsibilities:Responsible for the establishment, implementation, and maintenance of the corporate Quality Management System and for regularly reporting on the performance and effectiveness of the Quality System.Management responsibilities include directing staff and managing budgets for Quality Auditing (internal, supplier, and regulatory), Quality Engineering, Quality Training, Document & Configuration Control, Quality Control, Complaint Handling, and Final Product Release. Provide advice and guidance to product development teams to ensure design controls are properly implemented and product designs are correctly translated into manufacturing. Serve as technical expert for protocols, equipment validations, process validations, and software validations including Part 11 compliance. Serve as instructional designer and trainer for all quality related training courses. Lead product improvement initiatives throughout company. Direct failure investigations and root cause analyses related to complaints and/or internal nonconformities. Implementation of successful CAPA programs. Selection, configuration, validation, and successful implementation of automated solution for managing processes and metrics for the Quality Management System. Successful Implementation of a business-focused quality system that resulted in registration to ISO13485:2003 through BSI. Lead cross-functional teams through the regulatory landscape leading to 510(k) submission and clearance. Lead cross-functional teams through regulatory requirements for the creation and control of labeling & packaging including the adoption of international symbols for product labels. |
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| Years | Employer | Title | Department |
| Years: 1997 to 2001 | Employer: Undisclosed | Title: Manager, Regulatory Compliance | Department: Undisclosed |
Responsibilities:Responsible for providing project management and regulatory compliance leadership for quality system and compliance programs and projects.Specific responsibilities included managing the Corporate Quality Audit program, identification and implementation of long-term strategies for quality system training, and managing audits from external regulatory agencies and customers. Successfully responded to FDA 483 observations and met with the LA District office to keep them apprised of our progress. Provided company-wide gap analysis with respect to FDA compliance, facility registration, Medical Device Reporting (MDR) practices and recall management. |
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| Years | Employer | Title | Department |
| Years: 1995 to 1997 | Employer: Undisclosed | Title: Sr. Manager Corporate Quality System Training & Documentation | Department: Undisclosed |
Responsibilities:Led a top-level cross-functional team to develop and implement a streamlined global Quality System resulting in a 70% reduction in audit findings within the first year of implementation and an additional 20% reduction in audit findings within the second year of initial implementation. The improved Quality System significantly enhanced the company’s ability to demonstrate regulatory compliance, reduced the time to market new products, and contributed to the financial stability and growth of the company.Successfully reduced turn-around time for Change Orders from an average of 45 days to less than 8 hours by implementing a business-focused change process that facilitated compliance and was easy to grasp and understand. Responsible for the identification and implementation of global long-term strategies for quality system training, change control, and document control for both North American and International business units. Specific responsibilities included serving as technical consultant for the development and implementation of quality system training courses, business software validations, and engineering change control initiatives. Management responsibilities included planning, directing, and managing an international staff (non-exempt and exempt) within the Corporate-wide Document Control and Quality System Training departments. Accountable for departmental budget of $1.5 million related to areas of responsibility. Successfully managed on or under budget for every year of responsibility. |
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| Years | Employer | Title | Department |
| Years: 1993 to 1995 | Employer: Undisclosed | Title: Quality System Training Specialist | Department: Undisclosed |
Responsibilities:Served as technical consultant for quality system training and related development activities.Served as a key team member in the successful development and implementation of an automated tracking and notification tool for quality system training. Developed and implemented conceptual training modules to enhance the understanding of the intent of the quality system and other quality, regulatory and business requirements. Successfully established and implemented world-wide quality system training programs ranging from foundational to advanced courses supporting cGMPs, US FDA regulations, ISO standards, and European Medical Device Directives. |
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| Years | Employer | Title | Department |
| Years: 1988 to 1993 | Employer: Hollister Incorporated | Title: Undisclosed | Department: Undisclosed |
Responsibilities:Lead Auditor for FDA Certified and ISO9002 Registered Medical Device Manufacturer.Responsible for maintaining cGMPs through the implementation of documented procedures and one-on-one training with employees. Wrote and implemented procedures to assure compliance with QSR and ISO9002. Responsible for performing product audits on pre-sterilized and post-sterilized product. Responsible for placing biological indicators and preparing bio-burden samples for sterilized product. Analyzed post-sterilization test data for acceptance. Performed WIP, Finished Goods and Quality System Audits. Performed calibration activities for QA measuring & testing devices. Responsible for designing and implementing a database tracking methodology for defect reporting that facilitated ongoing analysis of defect trends. Provided root cause analysis support for corrective & preventive action. Assisted Senior Quality Assurance Engineers in developing and implementing ongoing protocols and SPC projects. |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2001 to 2004 | Country / Region: UK/Basingstoke | Summary: She provided Quality System & Regulatory Compliance training in conjunction with the rollout of a new quality system for the company. |
| Years: 2004 to 2004 | Country / Region: France/Strasbourg | Summary: She conducted Quality System Assessments and evaluated compliance programs in preparation for a global quality system re-engineering effort. |
| Years: 2007 to 2008 | Country / Region: Germany/Nuremberg | Summary: She is conducting Regulatory Compliance audits for a large medical device company. |
| Years: 2001 to 2004 | Country / Region: Mexico/Maquilidoras | Summary: She was responsible for course development and delivery of Quality System & Regulatory Compliance training for 2 large manufacturing facilities. |
| Years: 2009 to 2009 | Country / Region: Ireland/Galway | Summary: Expert conducted quality system audits for large medical device manufacturing facilities |
Career Accomplishments
| Associations / Societies |
|---|
| Regulatory Affairs Professional Society (RAPS) American Society for Quality (ASQ) – Management, Auditing, & Biomedical Divisions ASQ Senior Member |
| Licenses / Certifications |
|---|
| ASQ Certified Quality Auditor ISO9001 Lead Auditor Configuration Management, Certificate Sterilization & Microbiology Training, Certificate Situational Leadership II Training, The Ken Blanchard Companies, Certificate Team Top Gun, Effectiveness Dimensions International, Certificate Lean Manufacturing Management, Certificate |
| Awards / Recognition |
|---|
| President's Award, ALARIS Medical Systems Director's Award, ALARIS Medical Systems |
Additional Experience
| Training / Seminars |
|---|
| Quality System Training based on ISO 9001:2000 Quality System Training based on ISO 13485:2003 Risk Management Training based on ISO 14971:2007 Regulatory Compliance Training based on 21 CFR Part 820 & Part 11 Electronic Document Management & Engineering Change Control Best Practices Managing a CAPA System in a regulated environment Complaint Handling for Medical Devices & Diagnostics Trainer, ASQ Quality Auditing Body of Knowledge. |
| Vendor Selection |
|---|
| She supports clients in defining system requirements, preparing Requests for Proposals & Quotes (RFP & RFQ), and selecting appropriate quality system Off-The-Shelf software applications to meet individual compliance needs and business goals. |
Fields of Expertise
business system design, business re-engineering, business process re-engineering, business startup, project management, software project management, ISO 9000 quality system documentation, medical device auditing, Current Good Manufacturing Practice, ISO 9001, medical device, auditing, ISO 13485, gap analysis, quality, internal audit, change control, business process management, business strategy, stage gate process, first article inspection, American Society for Quality Control, acceptance test, enterprise resource planning software, enterprise resource planning, benchmark, plastic medical device, design-for-quality, therapeutic device, biomedical instrumentation, disposable medical device, biomedical product development, product development cycle time, stent, manufacturability design review, design for manufacturability, defect, medical device design, new product development management, design process, electronic medical device, biomedical device, medical instrument, surgical instrument, medical pump, implantable device, biomedical diagnostic instrumentation, bioinstrumentation