A Guide to GMP Investigations and Corrective Actions: Clear and Simple (publication planned for 2016)

A Guide to GMP Investigations and Corrective Actions: Clear and Simple (publication planned for 2016)

Unwanted quality events and deviations occur in even the best organizations.  When they happen, investigations help to identify what caused the event and provide information on options for how to prevent a recurrence.  This book provides information on the regulatory expectations for such investigations and reports, along with tools that can be used to more effectively and efficiently determine the root and contributing causes.  Other topics include “human error,” guidelines for interviewing, and integrating risk management into an investigation program.  Sample worksheets, templates, and checklists are included.

Other Items

A Guide to GMP Investigations and Corrective Actions: Clear and Simple (publication planned for 2016)
A Guide to GMP Investigations and Corrective Actions: Clear and Simple (publication planned for 2016)

Unwanted quality events and deviations occur in even the best organizations. When they happen, investigations help to identify what caused the event and provide information on options for how to prevent a recurrence.
GMP in Practice, 4th Edition (2011)
GMP in Practice, 4th Edition (2011)

As manufacturing and distribution practices get more complex and more global, manufacturers cannot just focus on one or two sets of requirements – it is too difficult to operate a quality system that has a multitude of variations to meet the individual requirements of a particular national authority.
Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple (2006)
Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple (2006)

The book begins with history, definitions, how we think about risks and hazards, it gives overview of the risk management process and commonly used risk assessment methods and tools. It also explores the phases of the risk management process in detail and examines how the various tools can be applied in identifying hazards and evaluating their potential impact and affects.
GMP and Quality Auditing: Clear and Simple (1997)
GMP and Quality Auditing: Clear and Simple (1997)

This guidebook provides proven methods and techniques for performing effective audits that serve your department, your company, and you. Topics covered relate to the four key competencies essential for successful GMP audits.
Documentation Systems: Clear and Simple (1997)
Documentation Systems: Clear and Simple (1997)

Documentation, when done correctly, is the greatest tool for product quality consistency, personnel training, and operational efficiency. This text covers everything readers need in order to systematically address all aspects of the function and the creation of a superior documentation system.
Training for the Healthcare Manufacturing Industries: Tools and Techniques to Improve Performance (1993)
Training for the Healthcare Manufacturing Industries: Tools and Techniques to Improve Performance (1993)

Training is critical to compliance, product quality, and profitability. Focusing on employee performance and using a systematic approach to design, develop, deliver, and measure effectiveness of instruction can optimize the training investment.