James Bardunias

James J. Bardunias

Senior Manager, Corporate Audit at Pfizer Inc

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Location:
235 E 42ND ST, New York City, New York, United States
Company:
Pfizer Inc
HQ Phone:
(212) 733-2323

General Information

Experience

Manager of Operations, Quality Auditing Services ( QAS  - Stelex Inc

Director  - Xybion Corporation

Recent News  

James J. Bardunias Jim Bardunias is currently Manager of Operations, Quality Auditing Services (QAS) at Stelex.Jim has been responsible for technical writing, project management, site and regulatory audits, and quality training both at Stelex and at client companies.As part of Stelex University, he has developed and presented several courses including: Introduction to FDA Regulations and Computer System Validation (CSV), Designing and Performing a Risk Analysis, Executing Test Protocols, Annual cGMP Training, and 21 CFR 11 - Electronic Records and Electronic Signatures.

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Jim BarduniasJim Bardunias is currently Manager of Operations, Quality Auditing Services (QAS) at Stelex.Jim has been responsible for technical writing, project management, site and regulatory audits, and quality training both at Stelex and at client companies.As part of Stelex University, he has developed and presented several courses including: Introduction to FDA Regulations and Computer System Validation (CSV), Designing and Performing a Risk Analysis, Executing Test Protocols, Annual cGMP Training, and 21 CFR 11 - Electronic Records and Electronic Signatures.

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Instructor James Bardunias, stated, "It is always rewarding to work with the agency and to gain NCTR's perspective on GLP Compliance.

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