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Investigations Operations Manual 2019

April 23, 2020
An investigation doesn't have to be full of surprises ... as long as you know the rules that investigators will be operating under before they walk in the door. Know the investigators' expectations and rights. Find and fix problems before they end up on a Form 483 or warning letter.

Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

April 23, 2020
Increase competitiveness and accelerate development of generic drugs with the "rule of three" and priority review designation. The report explains the FDA's new policy and shows how to navigate the new pathway to approval.

Planning an Audit Response: How to Handle MDSAP Findings

April 15, 2020
This management report will show you how to develop a standard operating procedure (SOP) that tells everyone involved what needs to be done and when to do it. The report provides step-by-step instructions for an audit response.

The Revised ICH E8: A Guide to New Clinical Trial Requirements

April 15, 2020
With ICH E8(R1) set to be adopted in June 2020, your planning, design and conduct of clinical trials will look different than they do today. This management report shows you how to leverage the revised guidelines’ quality-by-design approaches, expanded study designs and data source considerations.

The Road to a Pharmaceutical Quality System in the EU

April 15, 2020
Does your quality management system comply with EU standards? In this management report international quality management and auditing expert Stephanie Blum explains the EU’s PQS requirements — including ISO standards and ICH guidelines.

Medical Device Trials in the EU: A Guide to the New EU MDR and Revised ISO 14155

March 9, 2020
This management report provides insight into the EU MDR’s extensive requirements for documenting, conducting and reporting clinical trials, including which devices are exempt. Manufacturers of non-exempt devices must set up a clinical trials program using both EU MDR and ISO/DIS 14155:2018.

Clinical Trials Adverse Event Reporting Guide - 2020 Edition

March 9, 2020
The Clinical Trials Adverse Event Reporting Guide covers more than 20 guidances from the FDA, HHS and the ICH and includes the text of all regulations pertaining to reporting adverse events in clinical trials.

Managing Data and Documentation for FDA Inspections - 2019

February 5, 2020
Is your company’s data and documentation organized and ready for your next FDA inspection? This management report will help you get control of your data by using industry best practices and SOPs.

Design Change Analysis: Five Steps to Compliance

January 30, 2020
This management report explains the design change procedure required by the FDA, including five steps that most devicemakers don’t realize are necessary until an FDA inspection points out the gap in a company’s procedures and documents.
Writing SOPs: Best Practices for Life Sciences Companies

Writing SOPs: Best Practices for Life Sciences Companies

December 9, 2019
Your standard operating procedures are one of the first things FDA investigators will look at during an inspection. Yet, "inadequate SOPs" rank among the most-frequently cited Form 483 observations. This new management report will teach you the practical techniques you need for crafting well-written, fast-read, flexible and compliant SOPs - SOPs that will meet FDA requirements as well as today's globalized expectations.
Using ISO 11607 to Develop Risk-Based Device Packaging

Using ISO 11607 to Develop Risk-Based Device Packaging

December 9, 2019
Using case studies and other frontline knowledge this report will show you how to leverage a risk-based packaging approach to prevent nasty audits and recalls ... without busting a hole in your compliance budget. With it, you'll get step-by-step guidance through the bewildering FDA packaging requirements, beginning with a discussion of how and why packaging is causing significant harm to devicemakers. You'll also learn why your packaging might be at risk - and what you must do to reduce field complaints, recalls or FDA enforcement actions.
Using Social Media in Clinical Trial Recruitment

Using Social Media in Clinical Trial Recruitment

December 9, 2019
Today, one in five sponsors uses social media to engage, recruit, and retain subjects for clinical trials. And why not? Clearly, social media is increasingly where your prospective study subjects are going to be found. This report is designed to help unsure clinical trial recruiters put aside their concerns and go ahead with social media recruiting of trial subjects. And if you're already using social media, it's an opportunity to hear how other organizations are overcoming challenges and employing social media for increasingly successful recruitment.

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