We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Store » Books » Pre-Approval Inspection: Four Steps to Success

Other Options

PDF Edition

$177.00

PDF Edition - 3-4 Copies (10% Off)

$159.00

PDF Edition - 5-6 Copies (15% Off)

$150.00

PDF Edition - 7-9 Copies (20% Off)

$142.00

PDF Edition - 10+ Copies (25% Off)

$133.00

Pre-Approval Inspection: Four Steps to Success

$177.00
Books

Product Details

Pre-Approval Inspection
Four Steps to Success

What do you need to know and do prior to your pre-approval inspection?

Everything rides on your ability to support the claims you made in your new drug application — especially when it comes to the data underpinning the Chemistry, Manufacturing and Controls section.

Would a step-by-step guide come in handy?
 

You need to have the right answers to 3 key questions FDA investigators will ask during your pre-approval inspection:
 

  1. Is your facility ready for commercial manufacturing?
  2. Can you meet the commitments and specifications laid out in your application?
    and, most important of all ...
  3. Are your data and data collection methodology reliable?

You can answer yes, by following the 4 key steps outlined in Pre-Approval Inspection: Four Steps to Success:

  1. Verify application integrity: Make sure your development data and operations are adequate to support the application
  2. Verify GMP compliance: Confirm that your company is meeting all the rules
  3. Prepare to host the FDA inspection: Train your staff to interact appropriately with investigators
  4. Perform mock inspections: Identify gaps and weaknesses and correct them before investigators spot them

This FDAnews Brief gives you a concise, point-by-point map to follow to pre-approval success, from developing an inspection SOP to making logistical decisions to handling investigators questions effectively, and surviving the data integrity audit.

A smooth pre-approval inspection not only helps you get to market sooner, it helps set the tone for future GMP inspections you will face. Order your copy of Pre-Approval Inspection: Four Steps to Success today.

PDF Edition

 

Available Format

PDF Edition — $177

Who Will Benefit

  • Quality lead
  • Research and development staff
  • Regulatory affairs
  • Production supervisors

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.

  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing