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 all-new 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.

Buy Now!
This First Edition of Taming the Change Control Beast: Creating and Maintaining Effective Change Control Forms is expected to sell out quickly. Future editions and updates may be priced higher. That’s why it’s a good idea to order your copy today. Make sure to order a copy for everyone in your organization who has a hand in creating and maintaining change control forms. Taming the Change Control Beast is priced at $377 and is available in print and PDF format.

Satisfaction Guaranteed
There's no risk when you purchase from FDAnews with our money-back guarantee. Not satisfied with your publication? Return the hard copy within 30 days (in resalable condition), and we will refund 100 percent of your purchase price (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.

Interested in purchasing more than one print copy? Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Order below by clicking submit and then change your quantity in the shopping cart. The discount will be calculated automatically. 3-4 copies – 10% 5-6 copies – 15% 7-9 copies – 20% 10+ copies – 25% Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally with any questions. Interested in Electronic Multi-user Access? Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. For more information please contact Customer Service: Phone:  +1 (703) 538-7600 or toll free (888) 838-5578 Email:  customerservice@fdanews.com