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Perspectives on Clinical Trial Agreements: What Sites, Sponsors and Stakeholders Need

August 17, 2021
Learn how to view clinical trial agreements from all viewpoints to ease negotiations and build a mutually beneficial agreement.

Protecting the Pharma Supply Chain: FDA Efforts at Global Harmonization

July 14, 2021
This report provides the latest information on the FDA’s push for harmonized manufacturing regulations and standards across the globe. The report reviews developments in the U.S., including provisions in recent legislation and executive orders that create new supply chain rules.

Auditing Contractors and Suppliers: A Guide for Drugmakers

July 7, 2021
This comprehensive guide will help you build a GMP auditing program to oversee the quality of incoming goods and services.

Guide to Safety Reporting for Drugmakers: FDA Adverse Event Requirements

June 9, 2021
What, how and when to file adverse event reports is spelled out in a variety of regulations and guidances from the FDA and the International Council on Harmonization (ICH). This collection of 17 regulatory documents provides all the necessary information drugmakers need to report adverse events to the FDA.

Risk-Based Supplier Qualification: Finding the Right Vendors for the Most Critical Supplies

June 9, 2021
In this management report, international quality management expert Christian Gausepohl discusses the life cycle of a supplier relationship, how to determine excipient risks and ways to develop a supplier quality agreement.

Best Practices for Clinical Trial Site Management

May 13, 2021
This collection of in-depth articles from the pages of Research Practitioner, CenterWatch’s bimonthly professional development journal, provides guidance and information on best practices in a variety of areas central to a CRC’s job.

GCP Questions, FDA Answers - 2021 Edition

May 13, 2021
This collection of clinical research professionals’ information requests answered by the FDA’s Office of Good Clinical Practice sheds light on some of the most difficult and important topics in clinical trial research.

Drugmaker’s Guide to Process Validation: Principles, Methods and Compliance

March 2, 2021
Process validation can be confusing and complicated. With this management report, you’ll be able to align your validation choices with the expectations of regulators and discover the best methods for conducting a risk analysis, creating testing and sampling procedures and interpreting test results.

Process Validation for Devicemakers: Concepts, Methods and Models

March 2, 2021
This management report walks you through each step of the validation process. It provides the information you need to make decisions along the way. And it presents validation strategies, methods and tools to use to ensure compliance.

The Preapproval Inspection: Passing the FDA’s GMP Test

February 2, 2021
Are you prepared for the FDA’s more rigorous preapproval inspection (PAI) for new drugs? The PAI goes well beyond a typical good manufacturing practices (GMP) inspection. The FDA’s objectives are highly targeted and its updated procedures are much more challenging. This report provides all the information you need to handle a PAI successfully.

The New 510(k) Pathway: A Guide to Updated Requirements

January 6, 2021
This management report explains the new rules for selecting predicate devices, changes in device classification, opportunities for pre-submission meetings with the agency, additional postmarket testing requirements and expansion of the third-party review program.

Reliability of Medical Devices: Ensuring Availability and Safety

January 6, 2021
What are the requirements for device reliability and how can you measure it? Take your devices to the next level of reliability and achieve the best in product quality with this management report.

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