Greg Weilersbacher Eastlake Quality Consulting
President @Eastlake Quality Consulting
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WORK HISTORY
President @Eastlake Quality Consulting
San Diego, CA, US
Providing expert leadership and planning to companies seeking to obtain GMP manufacturing licensing through California Food and Drug Branch and/or pre-approval inspections by FDA.GMP Training (21 CFR 210-211), Data Integrity Training (FDA, WHO, MHRA), FDA Pre-Approval Inspection Training, Preparation of Facilities and Quality Systems for Inspection by California Food and Drug Branch, Mock Inspections of Manufacturing Facilities, Audits of Medical Device Manufacturers, On-site Supplier Qualification. Authoring of Quality Systems to support GMP testing, Production, Raw Materials, Receiving/Distribution, Material Review Board, Out of Specification Investigations, Equipment and Utility Systems. Perform internal audits (third party), identification of issues/growth areas, remediation of deficiencies. Remediation of FDA 483s for clients with OTC and commercial pharmaceutical productsNasal spray products - Analytical Review, OOS investigations, drug substance and drug product manufacturing, nasal spray pump and actuator troubleshooting, etc.
EDUCATION
San Diego State University
Bachelor of Arts - BA, Neurobiology and Behavior
San Diego State University
Master of Arts - MA, Neurobiology and Behavior
SKILLS
ABOUT GREG WEILERSBACHER EASTLAKE QUALITY CONSULTING
QUALITY ASSURANCE LEADERSHIP With 25 years of industry experience Greg Weilersbacher has successfully managed Quality Assurance, Quality Control, Analytical Development, Materials Management, GMP Manufacturing, GMP Facilities and Utilities Validation, and Facility Design and Construction Management in CMOs, biotechs and pharmaceutical companies. He licensed many GMP manufacturing and testing facilities through the California Food and Drug Branch, hosted FDA Pre-Approval Inspections, and has led numerous European QP inspections of GMP facilities he managed. Mr. Weilersbacher brings practical application of root causes analysis to Deviations and CAPAs and adds significant value to the execution of Supplier Qualifications, Regulatory Audit Preparation, Internal Audits, Training Systems and the evolution of a company’s Quality Systems. SERVICING: PHARMACEUTICALS, BIOTECH, and COMBO DEVICE/PHARMACEUTICAL PRODUCTS. President of Eastlake Quality Consulting Inc. focusing on start-up through large biotech/pharmaceutical companies. Provides logical and efficient Quality Systems designed to meet your unique needs.Global auditing of GMP manufacturers and laboratories for U.S. FDA and European Commission GMP compliance.Specialties: Quality Assurance Leadership, Authoring of Compliant yet Efficient Quality Systems, Auditing of Global Manufacturing and Testing Facilities, Senior QA Oversight for the Design/Construction Management/Validation of GMP Manufacturing and Testing Facilities, Performance of GAP analysis of Quality Systems, 483 Observation Remediation, Supplier Quality Agreements.Has previously held the positions of Associate Director of QA/QC and Director of Quality Assurance.
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