ComplianceOnline

Expert Profile


Shana Dressel
Senior Consultant, The Compliance Edge LLC

Shana Dressel is a highly proficient and accomplished leader in Quality Assurance with over 17 years of experience within FDA regulated industries, clinical development through large scale manufacturing (GXP), including large and small molecule drugs, medical devices, and dietary supplements.

Shana possesses extensive experience in company leadership, quality management, client interaction, regulatory inspection management, supplier management, and GXP auditing. She works with global, industry leaders of drug development and clinical research, providing guidance in regulatory, quality and compliance situations with extensive experience in all phases of drug and device development.

Trainings by Expert

Annual Current Good Clinical Practices (cGCP) Training
Category: Clinical Research , Healthcare Compliance (Hospitals) , GCP & Other Best Practices , Patient Recruitment , HEALTHCARE , Audit & Data Security , Healthcare Regulations , Clinical Trial Regulations , Risk Management & Controls , All FDA Regulated Functions , Audit & Inspection-Role , Healthcare Audit , Regulations & Guidances , Regulatory Affairs , Documentation and Data Management , Roles and Responsibilities

Risk Based Approach in cGMP - Quality Risk Management (QRM)
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Packaging and Labeling , All FDA Regulated Industry , FDA Audit and Inspection , GXP Pharmaceutical , GXP Medical Devices , Documentation and IT , Quality and Safety , Audits & Inspections , Supply Chain and Manufacturing , R & D , Quality & Safety , Drugs Regulations , Biotech Regulations , Audit & Inspection-Role , All FDA Reg. based Audit , Medical Device Inspection , Drugs Inspections , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Research & Development , Drug R & D , Device R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC