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Surviving an MDSAP Inspection: A Guide for Devicemakers

Surviving an MDSAP Inspection: A Guide for Devicemakers

December 9, 2019
The Medical Device Single Audit Program — MDSAP — is now being implemented by five countries with EU participation possibly in the offing. If you pass one MDSAP inspection youll be ready to pursue marketing authorization in five separate countries. The prescriptive nature of the MDSAP model makes it relatively easy to prepare for an audit — if you know what to expect.
Taming the Change Control Beast: Creating and Maintaining Effective Change-Control Forms

Taming the Change Control Beast: Creating and Maintaining Effective Change-Control Forms

December 9, 2019
Each company must maintain a state of control for any process used to manufacture regulated product. Showing the FDA that you do the same thing the same way every time keeps you on the agency's good side. Most companies rely on change control forms to track changes and describe current states of control. This management report is indispensable for anyone involved in producing or maintaining these crucial documents.
The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium - 2018

The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium - 2018

December 9, 2019
Since the 21st Century Cures Act opened the door for observational studies to join traditional clinical research in the drug and device approval process, many companies are taking the first steps into the use of real-world evidence. This new edition presents new information on the encouraging results those pioneers have found.
Strategies for Risk-Based Clinical Trial Monitoring and Inspections

Strategies for Risk-Based Clinical Trial Monitoring and Inspections

December 9, 2019
You're probably on the fence about employing a risk-based clinical trial monitoring program. Many are, preferring the old methods of 100 percent verification of data - and intense site visits - that they're more familiar with. But the fact is risk-based monitoring with a centralized data monitoring component can actually produce better levels of compliance than the old ways - if it's done correctly. This FDAnews management report will show you exactly what 'done correctly' is.
Supplier Quality Metrics for Devicemakers: Predicting and Selecting the Best

Supplier Quality Metrics for Devicemakers: Predicting and Selecting the Best

December 9, 2019
Medical devicemaking relies on a supply chain that often includes hundreds of companies and stretches around the globe, a network so vast that quality control can seem impossible.In this management report youll learn how to use predictive analysis of such metrics as delivery time, management efficiency and lot acceptance rate to identify suppliers you can count on and spot potential problems in the future.
Surviving an FDA Inspection: 2015 Edition

Surviving an FDA Inspection: 2015 Edition

December 9, 2019
Under the FDA's new inspectorate reorganization, the agency is using specialized teams of highly trained investigators. This is making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips.
Social Media Accountability for Drug and Devicemakers: Controlling the Online Conversation

Social Media Accountability for Drug and Devicemakers: Controlling the Online Conversation

December 9, 2019
The FDA may not hold you responsible for reader comments, but they will watch for the way you respond. This management report gives you an understanding of how to use social media for product promotion without running afoul of the agency.
Social Media Strategies for Drug and Device Companies

Social Media Strategies for Drug and Device Companies

December 9, 2019
No matter how fast the rules continue to change, this new management report will help drug- and devicemakers tap the power of social media. you'll find real-world strategies for building a strong presence on Facebook, Twitter and YouTube - without giving up control over your brand or risking marketing and advertising enforcement. With little specific guidance from the FDA, this report fills a critical gap.
Special Protocol Assessment: Winning FDA Support for Trial Design

Special Protocol Assessment: Winning FDA Support for Trial Design

December 9, 2019
A new FDA draft guidance gives drug sponsors detailed advice on how to take advantage of the opportunity to have agency staff review your protocol before you begin your trial. This management report explains what kinds of trials are eligible, how the process works and what to do if the FDA doesnt agree with your plans.
Strategies for Biosimilars Approval: A Map to 351(k) Success

Strategies for Biosimilars Approval: A Map to 351(k) Success

December 9, 2019
Want to know how Sandoz was the FDA's first biosimilar approval? Learn how Sandoz navigated the agency's approval process. FDAnews has a new management report that will give you candid "what to do - and how to do it" advice. Discover how to minimize the amount of time it takes to get your biosimilars approved - so you can speed your product to market and maximize your revenue generating potential.
Root Cause Analysis for Drugs and Devices

Root Cause Analysis for Drugs and Devices

December 9, 2019
This management report provides a step-by-step guide to conducting an effective root cause analysis, from recognizing problems that need to be investigated to documenting the investigation so regulators can see you are on top of the situation. The report also includes root cause analysis templates readers can customize for their own investigation.
Smart Labeling Self-Audits: Prescriptions for Global Regulatory Compliance

Smart Labeling Self-Audits: Prescriptions for Global Regulatory Compliance

December 9, 2019
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 this management report from FDAnews shows you how to do just that.

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