Effective Change Control Program – Challenges and Regulatory Requirements
February 12, 2019 - Online Event ON CA
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.