PDF Edition - Smart Labeling Self-Audits: Prescriptions for Global Regulatory Compliance

$397.00
Quantity Discounts
1 - 2
$397.00
3 - 4
$357.00
5 - 6
$337.00
7 - 9
$317.00
10 - 99
$297.00
View
Also Available:
Drug manufacturers consistently encounter two major "failures" in meeting global drug labeling requirements:
  1. They fail to disclose needed product safety information, and
  2. They fail to disclose it in a timely manner.

There's no doubt: complying with the detailed labeling requirements of every country in which you sell your products is a daunting task.

But … there is one established way to minimize your company's labeling errors and successfully sail through inspections.

Setting up your own labeling self-audit programs.

And a new management report from FDAnews shows you how to do just that.

Based on thousands of successful audits conducted worldwide, Smart Labeling Self-Audits brings you the kind of expert guidance you need to create your own self-audit programs.

This management report will help you become adept at understanding what labeling safety information must be reflected in your advertising, promotional materials and sales training for every market. And you'll learn to stay compliant with global regulations by:

  • Conducting desk/text audits of affiliate sites (detailed examinations of local labeling compared to companies’ core data sheet)
  • Conducting process audits on-site (reviews of labeling processes, including implementation by marketing and manufacturing)
  • Assigning the proper significance to audit observations
  • Engaging in self-audit best practices

You'll also get the inside story about the four key standards that all labeling auditors follow:

  1. Regulatory agency requirements for the country in which the labeling is used
  2. Company policy
  3. Company-wide global SOPs
  4. Affiliate SOPs and work instructions

Get the expert advice you need to design self-audit programs that will show you what’s working correctly … what's not … and what resources and actions you need to pass your next labeling audit.

Order Your Copy Today!

PDF Edition

Print Edition

 

Available Formats

PDF Edition – $397
 
Print Edition – $397

(Add $10 shipping and handling per book for printed books shipped to the US and Canada, or $35 per book for books shipped elsewhere. VA residents, please add 6 percent sales tax.)

Table of Contents

  • How to Comply with Labeling Audit Standards
  • Assigning Significance to Audit Observations
  • Self-Audit Best Practices

View the entire TOC

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 FDAnews Online Library – a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.

Our Guarantee

Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price. Return the hard copy within 30 days (in resalable condition) to receive your refund (less shipping/handling).

  • Drug company executives
  • Internal auditors
  • Quality assurance teams
  • Product safety officers
  • Compliance teams
  • Sales and marketing teams
  • Regulatory affairs professionals
  • Contractors
  • Subcontractors

Get Multi-user Access With The Electronic Books Library.
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. Contact customer service for a quote or more information.

Need Extra Copies?
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. Simply choose the quantity you wish to order the discount will be calculated automatically.

3-4 copies – 10%

5-6 copies – 15%

7-9 copies – 20%

10+ copies – 25%

Customer Service:
Phone:  +1 (703) 538-7600 or toll free (888) 838-5578
Email:  customerservice@fdanews.com