Debbie has over 20 years of experience in the pharmaceutical and medical device industry and most recently held the position of Global Vice President of Regulatory Affairs for West Pharmaceutical Services, Inc. in Exton, PA. Debbie has an extensive background, education and experience in all aspects of Regulatory Affairs & Quality Management Systems. She received a master’s degree in government, with an FDA concentration. As part of her formal education and training, Debbie completed an internship with the Food and Drug Administration. During that time, she developed and conducted cGMP training, contributed to webcasts, and learned about regulatory enforcement (483’s, Warning Letters, etc.) from inside the FDA, having spent a great deal of time on interpretation of regulations and guidance documents, along with other related activities. During her tenure with the Agency, Debbie developed excellent professional relationships with many current Agency personnel.
Debbie’s experience in FDA regulated industry, including pharmaceuticals, medical devices, combination products, primary & secondary components, food grade products, etc. is summarized below:
- Drug & device registration & listing
- Various drug applications, post approval changes, etc.: NDAs, ANDAs, Prior Approval Inspections, CBE-30s, CBEs, Annual Reports, etc.
- Various device submissions, post clearance changes, etc.: premarket notifications (510(k)), Clinical Trial Applications, Informed Consent (CI), Investigational device exemptions (IDE), device exemptions, LTF, etc.
- Drug Master Files (DMFs & MAFs), original submissions, technical amendments, annual reports
Debbie has implemented many successful submissions & regulatory strategies:
- Achieved two bar code exemptions
- Successfully drafted and submitted responses to numerous customer deficiencies
- Obtained reduced post approval changes from FDA (multi-Centers) for major changes from prior approval supplements to CBE-30, and from prior approval supplements to Annual Reportable
- Developed & implemented two of the largest multi-site ISO-9001 based Quality Management Systems in the world
- Successfully executed comparability Protocols/Comparative Analyses
- Developed programs to ensure proficiency with cGMP & QSR training
Debbie’s other areas of expertise include: labeling, promotion & advertising, Human Factors Engineering/Studies (HFE/S), simulated clinical trials/studies, clean rooms, gowning, aseptic techniques, medical device reporting (MDR) requirements, verification & validation (V&V) programs, internal auditing, corrective and preventive action (CAPA), supplier programs, etc.
In this important client delivery role, Debbie will serve as a lead subject matter expert on FDA regulatory, quality management and compliance matters and will work as the Managing Consultant on a variety of projects for our clients.
We are thrilled that Debbie has chosen to join Compliance Architects® after a long and very successful career within FDA-regulated companies. We know we are very fortunate to have her. We ask that you join me in congratulating Debbie and welcoming her to our team!
John C. (Jack) Garvey
Principal / Chief Executive Officer
Compliance Architects LLC