FDA Regulatory Compliance Consulting

Guidance on US FDA regulations, compliance, inspections, and investigations since 2017.

Services to clients include assistance with:

  • Audits

  • Validation

  • Inspection

  • Warning Letter Responses

  • SOPs (Standard Operating Procedures)

  • cGMP (current Good Manufacturing Practices)

  • Quality Control

  • IQ/OQ/PQ of Equipment

  • ISO Gap Assessments

  • Supplier Audits

  • Form 483

Contact Us

Diane Konopa

d.konopa@konopakonsulting.com
(815) 742-6494

Career Experience

Software

  • Value Stream Mapping

  • Lean Six Sigma Methodology

  • Budget Management

  • High Potent Drug Controls

  • Strategic Leadership Skills

  • Team Management

  • Pilgrim Smartsolve (EDOC and ECAPA)

  • Omnic (Spectroscopy Data Collection)

  • Minitab (Data Analysis, Statistical and Process Improvement)

  • Autoscribe Matrix (Laboratory Information Management System)

  • Chromeleon (Chromatography Data System)

  • JD Edward (ERP)

  • QAD CEBOS (Quality Management)

  • Microsoft Office Suite

Skills

  • Computer Validation

  • Equipment, Utility and Process Validation

  • Strategic QC/QA Planning

  • Product Inspections / Complaints

  • Site Investigations and Root Cause Analysis

  • cGMP Training

  • Software Implementations

“Nothing is more expensive than a missed opportunity.”

– H. Jackson Brown, Jr.

Get in Touch…

to schedule a consultation to discuss your needs, how I might best support you, and the rates for services.