Challenges of Change Control Protocols

This training program will provide attendees with a better understanding of the importance of a change control procedure, what areas inspectors tend to look for during an audit and the challenges that change control programs present to companies in their efforts to manage it. Common deficiencies will also be discussed and attendees will be provided a template to evaluate their own programs.

Why Should You Attend:

An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents. To control this process, one must have both a defined change control procedure that outlines responsibilities and documentation requirements and also a form by which required information is recorded. The effectiveness of these items will determine the success of your change control program.

This webinar will concentrate on three major points:

• The regulatory requirements for change control and what it applies to.
• How to develop a change control SOP that will define what is required, responsibilities, and a means to quickly provide summaries of changes to investigators.
• What are some of the common deficiencies cited by regulatory auditors?

In addition, the webinar will also highlight some of the benefits that a well maintained change control program provides to a company along with reviewing when change control is not required. Attendees will be able to ask questions on issues relating to their own change control procedure.