Inspection Navigator: A Devicemaker’s Guide

$997.00
No Need to Fear FDA Inspections!
What if you had a simple, inexpensive “silver bullet”
that protects you against FDA inspection failures?

Introducing Inspection Navigator: A Devicemaker’s Guide from FDAnews.
It guarantees you always meet FDA compliance requirements.

While FDA inspections are a way of life, fear of failing them needn’t be. In fact, if you, your employees and facilities are in full compliance, FDA inspections should be just another day at the office — and that’s the way it can be.

The new Inspection Navigator reference and training tool provides a treasury of detail on FDA compliance regulations, as well as wisdom and insider insights into best practices for managing — and passing — your inspections. Best of all, this vast library of reference materials and training materials provides resources for every member of your management team at all compliance levels.

Trust this compliance guide, and you will handily satisfy FDA inspectors.

Why risk wasted time and costly delays responding to Form 483s?

While FDA inspections can be complex and tricky — especially given the recent inspectorate reorganization — they are also eminently manageable if you have proper guidance.

Given the high cost of responding to FDA inspection violations — which can add up to months of bureaucratic red tape — it’s far easier and cheaper simply to make sure you’re in compliance. That’s why it makes sense for so many medical device companies to trust the Inspection Navigator to keep staff informed and trained on current protocols.

This single multimedia library covers the entire FDA inspection process —
so you’re confidently ready for anything

In a lively variety of webinars, eLearning courses, special reports, books, articles and videos, the Inspection Navigator gives your staff safe, proven responses to virtually all FDA inspectors’ queries and requests — including those regarding employee training requirements.

This comprehensive reference and training tool helps you calmly handle all elements of FDA inspections, by mastering critical skills such as these:

  • Best and worst inspection practices
  • Understanding the FDA’s new inspection process
  • Preparing your facility for inspection
  • Preparing your employees for an inspection
  • Basic and advanced training for subject matter experts
  • Surviving a regulatory interview in the facility
  • Surviving a surprise regulatory review
  • How to create an inspection response team
  • Key elements of every inspection war room
  • Creating your investigations operations manual

Get inspection survival advice from leading FDA and industry experts

When you use the Inspection Navigator to prepare your team, you know you’re getting inside insights. For example, you’ll receive seven exclusive videos of renowned FDA inspection experts, who give their studied recommendations on problems like these:

  • Former FDA Investigators Tell All — 10 Best and Worst Things to Do, featuring a panel of FDA inspection veterans, led by former FDA Office of Enforcement Director David Elder
  • How to Assure Your Seven Subsystems are in Compliance and Linked Together, from the viewpoint of FDA investigator Lori Lawless
  • Secrets of QSIT-Based Medical Device Inspection Preparation, by QSIT co-author Tim Wells
  • Best Practices in FDA 483 and Warning Letter Management and Recovery, a panel discussion led by Elaine Messa of NSF Health Sciences
  • A Day in the Life of FDA’s Field Investigators, featuring a panel of current FDAers led by Lori Lawless of the Baltimore District Office
  • Program Alignment and FDA Operations, a presentation by FDA Deputy Commissioner for Global Regulatory Operations and Policy Howard Sklamberg
  • How to Assure Your Seven Subsystems Are in Compliance

Train your team with proven strategies: Let them learn from webinars featuring renowned inspection preparation experts

If you want to be sure you’re giving your people the most accurate, savvy preparation for FDA inspections, call on the industry’s top authorities. Inspection Navigator includes webinars — PowerPoints and audio lecture — on these critical issues by just such renowned experts:

  • Preparing for an FDA Inspection, by John Avellanet of Cerulean Associates, LLC
  • Inspectional Readiness, by noted quality and compliance experts Julie Larsen and Arnold Solomon
  • Create an Inspection Readiness Gap Analysis, by regulatory consultant and former FDAer David Lim
  • Device FDA Inspections: An Expert Tells All, by Jodi Scott of Hogan Lovells
  • Digging for Gold: How to Mine FDA’s Inspection Reports by attorney and FDA regulatory expert Michael Swit of Duane Morris
  • FDA’s New Inspection Approach by Kelly Thomas and Rich Yeaton of Atlantic Technical and Validation Services
  • FDA’s New Inspectorate Reorganization by consultant Joann Cochran
  • Delaying, Denying, Limiting, Refusing Inspection by Lynn Tyler of Barnes & Thornburg, LLP

Eliminate doubt: You’ll have essential regulatory documents at your fingertips

Inspection Navigator gives you the compliance requirements you’ll need to ensure that you fully understand what the inspector is looking for … and that you’re fully prepared. Here are just some of the documents you’ll receive:

  • Title 21 Code of Federal Regulations Part 820 — Quality System Regulations
  • Quality Systems Inspection Technique (QSIT)
  • FDA’s plan to change the way it conducts inspections — FDA Program Alignment Medical Devices and Radiological Health Action Plan 2015
  • Sample FDA inspection forms

Inspection Navigator: An extraordinary investment at an extraordinary price

Consider that by helping you avoid FDA compliance violations, the Inspection Navigator can save your company months of time and tens, even hundreds of thousands of dollars in compliance corrections.

Consider also that these materials have a list-price value of more than $10,000:

  • 4 eLearning courses
    • What to Expect When You’re Inspected
    • Surviving a Regulatory Interview
    • Surviving a Regulatory Interview: In the Facility
    • Surprise! Regulatory Inspection Today
  • 7 expert instructional videos
  • 8 expert instruction webinars
  • 6 special inspection survival-guide FDAnews reports
    • Investigations Operations Manual
    • Use QSIT to Your Advantage in FDA Device Inspections
    • Medical Device Inspections Guide
    • Guide to FDA Medical Device Regulations
    • Effective Internal Audits and Quality Control Units for Devicemakers
    • Device Supplier Controls: Avoiding an FDA Form 483
  • 22 practical inspection FDAnews guide articles
    • Creating an inspection policy
    • Preparing the facility for inspection
    • Preparing Subject Matter Experts
    • Mock audits and interviews
    • Best and worst inspection practices
    • The four different types of QSIT inspections
    • Responding to 483s
    • How to create an FDA inspection war room
    • How to create an inspection response team
    • How to perform a pre-inspection compliance audit
    • And more

Plus, you’ll never miss an update — as new developments occur with the FDA’s new inspection protocol the Inspection Navigator will send you an article detailing how the changes could affect you.

Finally, consider that you can add this protection to your company and your employee team — the entire Inspection Navigator: A Devicemaker’s Guide — for only $997.

You must be satisfied with this high-level training package — or your money back

Not satisfied with this training package? Simply, notify FDAnews within seven days of receipt of Inspection Navigator and return the electronic thumb-drive copy, and we will refund 100 percent of your purchase price.

To order or for more information, phone toll free: (888) 838-5578