PDF Edition - Taming the Change Control Beast: Creating and Maintaining Effective Change Control Forms

August 2009
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Every FDA-regulated company must maintain a state of control for any process used to manufacture any regulated product. Showing the FDA that you do the same thing the same way every time keeps you on the agency’s good side.

But over time, manufacturers buy better equipment, implement new technologies, adopt new materials, and improve designs. Each process still must be executed in a state of control, but maintaining that state and documenting changes becomes harder and harder. Yet it’s a safe bet that when the FDA inspectors visit, or auditors review quality processes, they’ll be looking closely at your documentation.

Most companies rely on change control forms to track changes and describe current states of control. Adopting and maintaining change control forms that work can be a quality manager’s greatest challenge.

Taming the Change Control Beast: Creating and Maintaining Effective Change Control Forms is the indispensable management report for anyone involved in producing or maintaining these crucial documents. This report delivers:

  • The essentials — what must be included in any change control form
  • What FDA requires — the rules on what forms must be and must do
  • The FDA’s expectations (and red flags!) regarding change control forms
  • Best ways to present the information contained in the form
  • Common shortcomings of change control forms in use today
  • Electronic change control forms and their unique challenges
  • And much more!

Indispensable features of this report include: Step-by-step analysis of what elements must be included in a change control form, as well as guidance on what to leave out ... plus text of the FDA rules that mandate change control forms.

Taming the Change Control Beast: Creating and Maintaining Effective Change Control Forms is the ideal tool for Quality, Regulatory Affairs, Compliance and Legal personnel, as well as Change Control specialists.

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