Expert Profile
Tim Stein
CEO , Business Performance Associates, Inc
Tim Stein, Ph.D., is the founder and CEO of Business Performance Associates, Inc. (BPA), a consulting firm that specializes in both quality systems for biomedical companies and computer system validation. Tim is the author of Computer System Risk Management and Validation Life Cycle which is scheduled for release in April 2006 by Paton Press. Tim has written a set of policy and procedure documents and templates for computer system validation that are available through ComplianceOnline.
Trainings by Expert
Catching Up on Computer System Validation: Meeting FDA and ISO 13485: 2003 Requirements
Category:
FDA Validation
Catching Up on Computer System Validation: Meeting FDA and ISO 13485: 2003 Requirements
Category:
Medical Devices
,
IT control and PCI compliance
,
All FDA Regulated Industry
,
FDA Validation
,
Life Sciences
3-hr Virtual Seminar: Aligning Medical Device Software Development with EU Requirements for a CE Mark (IEC 62304)
Category:
Medical Devices
,
Life Sciences
,
Documentation and Data Management
Medical Device Software Development & Management - Comprehensive Training Package (4 Courses)
Category:
Medical Devices
,
Life Sciences
,
Documentation and Data Management
Mobile Medical Applications: Software Regulatory Requirements
Category:
Medical Devices
,
Supply Chain and Manufacturing
,
HEALTHCARE
,
Audit & Data Security
,
HIPAA
,
Healthcare Regulations
,
Audit & Inspection-Role
,
Healthcare Audit
,
Medical Device Inspection
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
QA/QC
,
IT
Managing the Software Development Life Cycle to Produce Regulatory Documentation (for Medical Devices)
Category:
Medical Devices
,
QMS, ISO 13485, CAPA
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
QA/QC
