Steven Niedelman
Lead Quality System and Compliance Consultant at King and Spalding
- Role
- Lead Quality Systems and Compliance Consultant at King & Spalding
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
Experience
Lead Quality Systems and Compliance Consultant
Jan 2011 — Present
Skills
- U.s. Food and Drug Administration (Fda)
- Iso 13485
- Clinical Trials
- Regulatory Affairs
- Lifesciences
- Quality Control
- Gmp
- Medical Devices
- Capa
- Validation
- Life Sciences
- Regulatory Submissions
- Leadership
- U.s. Title 21 Cfr Part 11 Regulation
- Quality Auditing
- Biotechnology
- Pharmaceutical Industry
- Fda
- Quality System
- V&V
- Document Management
- R&D
- Corrective and Preventive Action (Capa)
- 21 Cfr Part 11
- Regulations
- Technology Transfer
- Drug Development
- Gcp
- Biopharmaceuticals
- Regulatory Requirements
- Due Diligence
- Quality Assurance
- Verification and Validation (V&V)
- Change Control
- Good Clinical Practice (Gcp)
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