Inspections & Auditing
FDA Warning Letter Remediation - Inspection Readiness - Mock FDA Inspections - Gap Analysis - Readiness Training - Vendor Qualifications - CRO/CDMO Inspections
Risk Management - Training - Document Management - Change Management/Change Control - eQMS/ELN - SOP Writing - Batch Record Review - Quality Manual Composition - Site Master File Creation
Data Integrity - Quality Control - Quality Assurance Deviations/Inspections/CAPAs
Inspection Readiness Programs - Master Site Validation Plans - Quality Protocol Development - Training Programs - eQMS Program Deployment - Deviation Management Programs - Vendor Qualification Programs
Study Site Support - Clinical Operations - Data Monitoring - Audits of Clinical Sites, CROs and Sponsors - Phase 0 thru Commercial Launch
KPIs - Metrics Dashboards - Cleaning Validations - Environmental Monitoring - Facilities - Supply Chain - Covering all aspects of production and documentation requirements
Global Pharmaceutical Quality Compliance Consultant ...
Warning Letter Remediation
GAP ASSESSMENT INNOVATION
PHARMACEUTICALS BIOPHARMACEUTICALS BIOTECH (mRNA) NUTRACEUTICAS CANNABIS MEDICAL DEVICES
Eric Wesoloski, Proprietor
Global Qualty Professional, Over 28 years of experience
Over 28 Years of Experience with Regulatory Health Authorities:
FDA, MHRA, ANVISA, EMEA, EU, PMDA, TFDA, TGA
I've overseen quality organizations of 2,000+ employees in 53 countries
Eric is a seasoned, thoughtful QA/QC professional who understands to navigate complex compliance and QA/QC issues with regulators and partners with clarity, tact, and subject matter authority. His leadership as Quality Director at Piramal was greatly appreciated and valued.
Eric is an outstanding professional who has very well developed leadership and continuous improvement skills. Eric has the maturity and flexibility to lead a large team to excellence or serve as a contributing member on such a team. Eric has the rare ability to combine creative problem solving with scientific discipline in a way that energizes people and achieves dramatic and lasting results. I highly recommend Eric for any manufacturing leadership or technical position. I would rehire him at any opportunity.
Eric is a people oriented strategic leader with excellent Quality and Regulatory experience in the Pharmaceutical Industry. He has a diverse background in the industry and does a good job in balancing business needs with complex regulatory challenges. It was good working with Eric because he had a people first management style without sacrificing the urgency needed to succeed in the dynamic world of pharmaceuticals.
Dr. Reinhard Koenig
Managing Partner, Avanulo
Pharma Quality & Regulatory Consultant
Process Design * Immature Quality Systems to Maturity * Quality by Design
Ensuring Proper Design, Monitoring and Control of Manufacturing Processes and Facilities (SISPQ)