Management Controls Under QSR and ISO 13485
Instructor:
Jeff Kasoff
Product ID: 700988
- Duration: 60 Min
Why Should You Attend:
Top management of a company is responsible for ensuring that all regulatory requirements are met. This concept is codified in both the QSR and ISO 13485. FDA officials have repeatedly stated that the management controls subsystem is the central subsystem because it is the "glue that holds the quality system together." Since it is individuals in top management that the FDA will typically seek to fine or prosecute in the event of major noncompliance, this session is key for those individuals who are members of top management, or those regulatory professionals who need to understand these requirements to assure top management is fulfilling its responsibilities. This session will discuss the requirements for Management Controls, including organizational structure, internal audits, establishment of a quality policy and confirmation it is being followed, establishment and contents of a quality system and quality plan, and of course all aspects of management reviews.
Areas Covered in the seminar:
- QSR and ISO 13485 requirements for management controls.
- Organizational structure.
- Establishment of an internal audit program.
- Establishment of your company’s quality policy.
- Contents of your company’s quality plan.
- How/when to conduct management reviews.
Who will benefit:
- Senior and mid-level management
- Regulatory management
- QA management
- Consultants
- Quality System Auditors
Jeff Kasoff
Director of Quality, Medivators
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. 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.
More Training By Experts
- Supplier Management: Challenges and Opportunities
- Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements
- The FDA Inspection Process: From SOP to 483
- Supplier Evaluation and Internal Auditing for FDA and ISO 13485 Compliance: Pack of Three Courses
- Training Requirements and Practices to Assure QSR and ISO Compliance
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
