This webinar will provide the 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 provide attendees a template in which to evaluate their own programs.
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 or issues relating to their own change control procedure.
Areas Covered in the Session :
- Review the current regulatory requirements for change control.
- Discuss when change control needs to be implemented and the main items it should cover.
- What are the major sections that need to be included in a change control procedure?
- What are the typical industry challenges associated with change control procedures?
- Review the benefits that a well-controlled change control process can provide.
- What are the most common deficiencies cited by regulatory auditors when auditing change control programs?
Who Will Benefit:
- Quality Assurance
- Quality Control
- Laboratory Personnel
- Equipment vendors