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Risk Management in Clinical Trials: The New ICH E6 Focus

Risk Management in Clinical Trials: The New ICH E6 Focus

December 9, 2019
When the International Council on Harmonisation (ICH) updated its good clinical practice guidance in 2016, it made major revisions to the section on sponsor responsibilities that emphasize the importance of risk-based thinking. In this report Dr. Susan Leister, Director of Quality Assurance at Technical Resources International, explains the significance of the new focus on risk management.
Process Validation: A Guide for Devicemakers

Process Validation: A Guide for Devicemakers

December 9, 2019
When must a process be validated? That is the first crucial question devicemakers must answer. But with no clear guidance from the CDRH, finding the answer can be difficult. This FDAnews Management report - provides you with the answers. This report will walk you through each point in the decision-making process, including how to determine if a product can be "fully verified," and how FDA inspectors define that term.
Promotional Communication: Keeping Up with FDA's Off-Label Use Policy

Promotional Communication: Keeping Up with FDA's Off-Label Use Policy

December 9, 2019
This report explores the draft guidances and other FDA activity on the subject of promotional communication, explaining what companies must do to stay on the right side of the agency's new policies and how to take advantage of the opportunities they present.
QSR-Compliant Purchasing Controls: A Five-Stage Plan

QSR-Compliant Purchasing Controls: A Five-Stage Plan

December 9, 2019
The FDAs Quality System Regulation is very clear: you must maintain control of your supplier networks. Follow this five-step plan explains what the regulation requires and how to make sure your system passes muster.
Quality Management Essentials: Expert Advice on Building a Compliant System

Quality Management Essentials: Expert Advice on Building a Compliant System

December 9, 2019
A strong quality management system is the foundation of a drugmakers success. This collection of essays from five of the drug industrys most knowledgeable practitioners illustrates exactly how to create or update a quality management system that hits all the right notes.
Quality Risk Management for Pharmaceuticals

Quality Risk Management for Pharmaceuticals

December 9, 2019
Drugmakers must have an effective quality system. However, a basic quality system that just covers the GMP requirements is no longer good enough. This management report will tell how QRM can be applied both proactively and reactively and explore the potential application of QRM during the different phases of the product lifecycle.
Preparing for the EU GMP Inspection

Preparing for the EU GMP Inspection

December 9, 2019
The FDA's GMPs and the EU's GMPs are supposed to be harmonized. Supposed to be. The reality is there are subtle but significant differences between the two. This new handbook from FDAnews tells you what you need to know about the similarities - and subtle differences - between FDA and EU GMP inspections. FDAnews reached out to four authorities on European drug manufacturing quality for their expertise. The result is a handbook you'll refer to whenever the EU inspectors come to call.
Preparing the New Drug Application: Managing Submissions Amid Changing Global Requirements

Preparing the New Drug Application: Managing Submissions Amid Changing Global Requirements

December 9, 2019
This book will bring you up to speed on recent changes to the NDA process - including the change from paper to electronic format - and guide you step-by-step through the application process. Whether you're an industry veteran or newcomer, this book will help ensure that your new drug does indeed make it to the marketplace.
Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers

Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers

December 9, 2019
This report — authored by international GMP expert Thomas Peither and associates — lays out the basics of building a four-phase qualification plan that satisfies US and EU requirements.
Pharma Change Control: Strategies for Successful Company-Wide Implementation

Pharma Change Control: Strategies for Successful Company-Wide Implementation

December 9, 2019
Drugmaking processes change constantly. New companies enter the supply chain, old ones drop off. New production machinery and software supplant old stuff. Things get complicated and before you know it, your files are filled with new specifications and revised SOPs. But the FDA likes things simple, clear cut and well tracked. That leaves you a lot of questions. Co-authored by GMP experts with international reputations, Pharma Change Control is the perfect starting point to rein in your pharmaceutical manufacturing processes.
Pharma Strategies in Latin America: Keys to Success

Pharma Strategies in Latin America: Keys to Success

December 9, 2019
This report covers all you need to know about entering the Latin American market, from research and clinical trials to postmarketing surveillance.
Pharmacovigilance in the European Union: A Guide to New Directive

Pharmacovigilance in the European Union: A Guide to New Directive

December 9, 2019
Navigating EU pharmacovigilance requirements is a complex task that starts in the early stages of drug development and extends right through the drug's life. This report will help readers navigate the EU's complicated regulatory landscape and stay compliant.

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