Laura Lappine

Laura is a seasoned professional with over 20 years of experience in the Pharmaceutical and Medical Device industries. She is a dedicated expert in Quality Assurance and is well-versed in managing complex regulatory environments with comprehensive knowledge of FDA, MHRA, and EU Regulations.

Her diverse expertise includes Quality Systems Management, GMP and GCP Auditing, Change Management, Policy/Procedure Development, Clinical/Commercial Release, Corrective/Preventive Action, Root Cause Analysis, Clinical Packaging/Labeling, Product Complaint Management, and Training Program Development. 

Laura provides expert oversight for third-party manufacturing, packaging, labeling, and finished product release, ensuring meticulous review and approval of all quality documents. Her career spans impactful roles in various organizations, showcasing her adaptability in different facets of Quality Assurance both in GCP and GMP.

Specialties:

• Quality Systems Management

• Clinical & Commercial Product Oversight & Release

• FDA, MHRA, EU Regulations

• Electronic Document Management Systems (EDMS)