BACKGROUND
FOCUS AREAS
More than 30 years of quality management system auditing, engineering, and management focused in the life sciences.
QMS Auditing (21 CFR Parts 210/211, 820; EU MDR/IVDR; MDSAP; ISO13485)
QMS Consulting/Remediation
QMS Training
As Sr. Director, QMS Consulting and Training, Carolyn works with our medical device and pharmaceutical industry clients in the areas of auditing, consulting and training.
Carolyn brings more than 30 years of quality system consulting, development, and management; quality system auditing; and quality engineering experience to each client engagement.
Carolyn has worked with a wide range of medical device and pharmaceutical manufacturers to create, remediate, and optimize their QMS processes to meet the requirements of FDA regulations, EU MDR/IVDR, ISO 13485, ISO 9001, and other key international regulations and standards. In addition, Carolyn uses her expertise in quality systems training and auditing to help clients effectively implement their QMS processes, review them through internal audit programs, and present and defend them in inspections and audits.
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EDUCATION:
Bachelor of Science, Chemical Engineering, Virginia Polytechnic Institute and State University (Virginia Tech)CERTIFICATIONS:
Certified Medical Device Auditor, American Society for Quality (ASQ)
Certified Quality Auditor, ASQ
Certified Six Sigma Black Belt, ASQ
Certified Quality Engineer, ASQASSOCIATIONS & MEMBERSHIPS:
2013-Present: Palmetto Section, American Society for Quality, Board Member
2019-Present: RAPS, Member -
AREAS OF EXPERTISE:
Quality Management Systems – Has created, implemented, managed, and remediated QMS processes compliant with FDA 21 CFR 820, 21 CFR Part 210/211, EU MDR/IVDR, ISO 13485, ISO 9001, ICH Q7, and more.
Auditing – Has conducted internal and supplier QMS audits; hosted Regulatory Authority inspections, and Notified Body and customer audits; managed internal and supplier audit programs; and trained new internal and lead auditors.
Experience auditing against 21 CFR 820, 803, 806; 21 CFR 210/211; EU MDD/EU MDR; EU IVDD/IVDR; MDSAP; ISO 13485; ISO 9001; ISO 17025.
Training – Has created and delivered engaging and effective in-person and virtual, instructor-led training for a variety of QMS topics, including FDA QSR/QMSR, EU MDR, MDSAP, auditing, supplier quality, risk management, NC/CAPA, root cause analysis, and overall QMS requirements, among others.
HIGHLIGHTED EXPERIENCE:
Served in leadership roles for multiple manufacturing facilities ($10 million to $300 million revenue) with responsibility for all aspects of the QMS and management of QA teams with 2 to 60-plus employees.
Managed front and back-room operations for multiple FDA facility inspections of an aseptic manufacturing site for contact lens solutions and OTC ophthalmic products under 21 CFR Part 820 and 21 CFR Part 210/211 regulations.
Managed all Notified Body and customer (private label manufacturing) audits to ISO 13485 and ISO 9001 for the same facility.
Led the mitigation of multiple Warning Letters and Form 483s to successful conclusion for clients through effective root cause analyses and CAPA planning and execution.
Led EU MDR transitions for multiple clients, including product technical documentation and QMS process creation and updates for compliance with new and changed regulatory requirements, MDCG guidance, and Annex XVI Common Specification requirements.
Led the development, implementation, and ongoing management of the quality management system for two start-up manufacturing facilities including a pharmaceutical blister packaging film manufacturer with a 21 CFR Part 210/211-compliant QMS.
Delivery of over 2000 hours of training with an average instructor rating of 6.6/7.0.
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