This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming. The difference between pre release and post release change control will be explained. Methods to control the transfer and approval of changes between the company and its suppliers or contract manufacturers will be explained. Change control forms will be provided and described in detail.

Why:

   FDA and ISO call for change control but do not provide any further guidance as to how to create a compliant system. The situation gets complicated when a company has suppliers or contract manufacturers and changes and approvals must pass from one to the other. This webinar will describe a system, based on the regulations and years of practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming. Change control forms will be provided and explained

Areas Covered in the Session:

    Change control procedure
    Pre release and post release change control
    Change transfer between company and suppliers
    Forms and SOP’s

Who Will Benefit:

    Development Engineers
    Production Management
    QA/ QC personnel
    Engineering management
    Regulatory personnel

About Speaker:

   Edwin Waldbusser retired from industry after 20 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/ non-conforming product programs.

   Edwin Waldbusser has a Mechanical Engineering from NYU and a from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.