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Challenges of Change Control: Implementation and Maintenance (MFGN63V)

Presented by: Kenneth Christie
 
(*) Single User Price. For multiple users please call 1-800-223-8720
Pre Recorded Webinar
60 minutes
  •  Tue, November 22, 2016
Event Description

Change Control: Challenges, Regulatory Requirements, Common Deficiencies and Benefits.

If your quality system program includes evaluation and documentation of changes made to validated equipment, utilities, processes and controlled documents along with several regulatory requirements, only then will it be deemed effective. You must have both documentation requirements and defined change control procedure outlining responsibilities as well as a form recording required information – if you need to control this process properly. What determines the success of your change control program is the effectiveness of these items.

There are three major points that this session by expert speaker Kenneth Christie will talk about:

  • Change control regulatory requirements and what it applies to
  • Developing change control SOP to define requirements, responsibilities and means to provide quick summaries of changes to investigators
  • Common deficiencies regulatory auditors observe

Also, the session will highlight few benefits that are bound to come with a well-maintained change control program and also review when change control isn’t mandatory. You will be able to get answers to your queries related to your own change control procedure. This webinar will help provide a template against which you can compare your own change control program, get insight into items to add to your procedures based on deficiencies cited by regulators, or items to include when trying to start a change control program for the first time.

Session Highlights:

  • 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 Should Attend

  • Quality Assurance
  • Quality Control
  • Manufacturing
  • Production
  • Regulatory
  • Laboratory Personnel
  • Management
  • Equipment Vendors
About Our Speaker(s)

Kenneth Christie | Manufacturing Regulatory Compliance SpeakerKenneth Christie
Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of quality assurance and validation management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the chief operating officer for VTS Consultants, Inc., located in Amhesrt, MA. Hi... More info

 
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    Event Title: Challenges of Change Control: Implementation and Maintenance
    Presenter(s): Kenneth Christie

 
 
 
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