Management Controls needed for an effective QMS to meet FDA QSR and ISO 13485 regulations

Participants will become familiar with the governing requirements for management controls by understanding the responsibilities that executive management is obligated to meet and the challenges executive management faces in meeting these requirements.

Areas Covered in the seminar:

• Importance of Management Controls
• Legal obligations
• Commitment
• Management Controls (quality planning, quality policy, quality objectives, management representative, management review, human resources, training)
• Challenges for your company
• Meeting those challenges

Who Will Benefit:

• Senior or Executive Management ("management with executive responsibility")
• Management Representatives
• Quality Managers and Professionals
• Compliance Managers and Professionals
• Internal Auditors

Instructor Profile:

Susan C. Reilly, has over 20 years of quality system, quality engineering, and regulatory compliance experience in the medical device area. Her company provides practical and cost-effective quality and regulatory consulting services to ensure conformance with FDA regulations, EU requirements, Canadian requirements, and ISO Standards.

Prior to becoming an independent consultant in 1999, she was Director, Quality Systems, at Medical Device Consultants, Inc. (MDCI) and Manager, Quality Assurance at Deknatel Division, Pfizer Hospital Products Group, Inc. She was also a Quality Engineer at Burron Medical Inc.

Ms. Reilly has served as an expert witness on behalf of the Food and Drug Administration and was an active participant in the FDA/Medical Device Industry Initiative Task Force. She is a member of the Advisory Committee for the ASQ Certified Quality Auditor.

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