Steps to Design and Develop an Effective Closed Loop Change Control System

Why Should You Attend:

Understanding your requirements for your company's change control system and planning the implementation will help you to avoid unnecessary changes due to gaps discovered later in the implementation process. This becomes even more critical when adding additional layers of communication due to outsourcing. As with any development effort, the starting point is a comprehensive set of requirements. Developing your company specific requirements for how changes are proposed, implemented and closed will reduce the risk of changes to the process later on.

This webinar will provide attendees with guidance on how to design and implement an efficient closed loop change control system.

Areas Covered in the Webinar:

• Is it ever too early for change control?
• Key elements of a closed loop change control system.
• Inputs that drive change control and traceability.
• Closing the loop around contract developers and manufacturers.
• Paper vs. Electronic; advantages and pitfalls.
• The myth of ‘the simple change’.
• Roles and responsibilities in change control.
• What auditors look for in change control?

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Quality Assurance
• Documentation Control
• Engineering Management
• R&D Management
• Manufacturing and Supply Chain
• Regulatory Compliance Associates and Managers

Instructor Profile:

Michael Kagan, is the Principal Consultant at M. Kagan & Associates, focused in the area of early stage product development, systems engineering and quality systems development. During his 25-year career in in-vitro diagnostics, Mr. Kagan has held a number of positions in manufacturing, product development, quality management systems and project management. He has worked for both established and early-stage medical diagnostics companies, including Ciba-Corning Diagnostics, Chiron, Bayer and Immunicon. Since 2008, he has been consulting specifically to early-stage and start-up companies, aiding them in the planning and development of products from conceptual stages through commercialization, including Design Controls and Quality Management Systems. He also holds a Bachelor’s degree in Electrical Engineering Technology from Wentworth Institute of Technology and has studied Biomedical Engineering at Case Western Reserve University and Worcester Polytechnic Institute.

Topic Background:

Change control systems require careful thought and planning to ensure that they are effective in addressing the cause or reason for the change. There are many electronic change control systems on the market; however, many early stage companies opt for a manual, paper-based system before investing in expensive electronic systems. In either case, the first step in developing an effective change control system is establishing the specific requirements for your company and products including how a change will be deemed effective.

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