Expert Profile
Jeff Kasoff
Director of Quality, Medivators
Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similary responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
Trainings by Expert
Supplier Management: Challenges and Opportunities
Category:
Medical Devices
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Audits & Inspections
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QMS, ISO 13485, CAPA
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Supply Chain and Manufacturing
,
Audit & Inspection-Role
,
Medical Device Inspection
,
Life sciences QA/QC
,
Supply chain & Procurement
,
Life Sciences
,
QA/QC
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements
Category:
Medical Devices
,
QMS, ISO 13485, CAPA
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
The FDA Inspection Process: From SOP to 483
Category:
Medical Devices
,
All FDA Regulated Industry
,
FDA Audit and Inspection
,
Documentation and IT
,
Audit & Inspection-Role
,
All FDA Reg. based Audit
,
Life Sciences
Supplier Evaluation and Internal Auditing for FDA and ISO 13485 Compliance: Pack of Three Courses
Category:
Medical Devices
Training Requirements and Practices to Assure QSR and ISO Compliance
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
All FDA Regulated Industry
,
Quality and Safety
,
QMS, ISO 13485, CAPA
,
Laboratory
,
Life sciences QA/QC
,
Life Sciences
,
QA/QC
Complaint Handling and Management: From Receipt to Trending
Category:
Medical Devices
,
Marketing and Promotion
,
Crisis Management
,
Life Sciences
Management Controls Under QSR and ISO 13485
Category:
Medical Devices
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Life Sciences
Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data
Category:
Medical Devices
,
All FDA Regulated Industry
,
Quality Management
,
Crisis Management
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life Sciences
,
Documentation and Data Management
ISO 13485 Made Easy
Category:
Medical Devices
,
Life Sciences
Strategies for an Effective Root Cause Analysis and CAPA Program
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
QMS, ISO 13485, CAPA
,
Life Sciences
