Therapeutic Specialization 

Inspections & Auditing

FDA Warning Letter Remediation  -  Inspection Readiness  -  Mock FDA Inspections - Gap Analysis - Readiness Training  -  Vendor Qualifications  -  CRO/CDMO Inspections

Quality Systems

Risk Management  -  Training  -  Document Management  -  Change Management/Change Control  -  eQMS/ELN  -  SOP Writing  -  Batch Record Review  -  Quality Manual Composition  -  Site Master File Creation

​

GMP Compliance 

Data Integrity  -  Quality Control  -  Quality Assurance  Deviations/Inspections/CAPAs

Program Development

Inspection Readiness Programs  -  Master Site Validation Plans  -  Quality Protocol Development  -  Training Programs  -  eQMS Program Deployment  -  Deviation Management Programs  -  Vendor Qualification Programs

Clinical Quality

Quality Operations

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

GAP ASSESSMENT INNOVATION

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

​

Experience Matters

I've overseen quality organizations of 2,000+ employees in 53 countries

Cardiology

Nephrology

Diabetes

Cell

and

Gene Therapy

Opthomology

Oncology

Featured Expert

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

President, AppliedBioPrograms

David Cahill

Managing Partner, Avanulo

Rick Augustine

Pharma Quality & Regulatory Consultant

Process Design  *  Immature Quality Systems to Maturity  *  Quality by Design

PROFESSIONAL RECOMMENDATIONS

MY SERVICES

Ensuring Proper Design, Monitoring and Control of Manufacturing Processes and Facilities (SISPQ)