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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.

Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

December 7, 2020
This report brings together all the guidances, statistics and instructions you need to successfully get through an FDA inspection.

New Adverse Event Reporting Procedures: A Devicemaker’s Guide to the IMDRF Code Transition

December 7, 2020
This management report provides a detailed explanation of the new set of adverse event codes and how to adapt to the changes to the FDA’s electronic submission methods and the EU’s new reporting form.

Quality Risk Management in the EU: Concepts and Compliance

November 9, 2020
This easy-to-follow reference covers all aspects of EU quality risk management: regulatory expectations, processes, methods and tools.

Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

November 9, 2020
With this management report, you’ll discover how to move a spreadsheet toward validation, determining the best ways to conform with data integrity requirements and uncovering what FDA inspectors are looking for in a validated data analysis and reporting tool.

Data Integrity for Drug and Device Manufacturers: Avoiding Breaches and Closing Gaps

November 9, 2020
This management report is your GPS for data integrity compliance. It explains what data integrity is, how to protect it, how to spot problems and what the FDA expects.

Pharmaceutical Quality Risk Management: Navigating New Regulatory Requirements

October 19, 2020
The COVID-19 pandemic is making it more difficult for pharmaceutical manufacturers to maintain production levels and meet regulatory requirements. With this report you can make your quality risk management (QRM) efforts more effective. By using our expert tips, you will be able to determine which risks you need to manage, how to consistently apply risk management principles, and ways to implement a successful QRM plan.

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