6 Steps to a Stress-Free eMDR Rollout

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The deadline for submitting eMDRs — Aug. 14 — has passed. There will be NO MORE paper Form 3500As, no more MedWatch reports.

But the required changeover from paper to electronic is not as simple as it may appear.

For example, before you can make the switch to eMDRs you must first set up an FDA production account for eMDRs.

Surprised? You shouldn't be.

It's not like you haven't been warned. The FDA has been discussing this change since 2009. That's six years.

But if you still need help the new report from FDAnews, 6 Steps to a Stress-Free eMDR Rollout, will tell you everything you must know to transform your paper MDRs into electronic versions — and maintain FDA compliance.

With it, you will learn the 6 Steps to eMDR success:

Step 1: Understand your eMDR options

Step 2: Know the ways to transmit

Step 3: Plan an eMDR acknowledgment strategy

Step 4: Get ready to implement

Step 5: Implement, test and go live

Step 6: Learn from your mistakes

And you'll find out about potential stumbling blocks — and what you need to do to avoid them, including:

3 different ways to transform your data. Your data has to be turned into an XML file and you MUST use the correct method for your particular organization.

Become a transaction partner with the FDA. What's a transaction partner? If you don't know, you'll be off on the wrong foot with the FDA from the very beginning.

Leverage the FDA's 'acknowledgement process' to show that you're in compliance. You have to prove your own compliance, so you'd better be sure you know what you're doing. Also, how to handle a 'negative acknowledgement.'

6 discrepancy-free testing areas. It's critical that your self-test proves there are no discrepancies before the FDA tests you. The report will tell you what you need to do.

Avoid time-related problems. How NOT to overlook deadlines and other time-sensitive requirements.

Clearly, the eMDR rollout is upon you.

Instead, get it right — the first time — with the FDAnews management report 6 Steps to a Stress-Free eMDR Rollout. Order your copy TODAY!

Order Your Copy Today!

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Table of Contents

  • Introduction
  • MDR Requirements
  • Step 1: Understand the eMDR Options
  • And More …

View the entire TOC

Who Will Benefit

  • Device manufacturing executives
  • Auditing and compliance officers
  • QA/QC managers and directors
  • Production managers
  • Production supervisors
  • Process development staff
  • Training managers
  • Regulatory affairs professionals
  • General/corporate counsel
  • Personnel new to the industry

Meet the Author

This report is largely drawn from comments made at an FDAnews webinar by Deborah Kacera, who is a regulatory and industry strategist at Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services.

As key strategist, Kacera is Pilgrim’s liaison with global regulatory bodies, including the FDA and European Medicines Agency, within the life sciences industry. An engineer by training, she has worked for Pilgrim since 2000.

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