Electronic Batch Recording and Batch Release for Drugmakers

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Introducing and implementing an EBR system is complex.
 

To succeed, a conversion requires systematic analysis, definition and a complete assessment of all regulatory requirements, process-based data and product-relevant information.

To help you better understand all the challenging steps involved, FDAnews and electronic systems expert Markus Roemer have developed Electronic Batch Recording and Batch Release for Drugmakers, a new management report for pharma companies considering an EBR system.

Roemer takes you by the hand and leads you step-by-step through key thought processes and issues you may confront in planning to move to an electronic batch recording system, including:

  • What regulatory requirements must be considered when an EBR system is implemented
  • What strategic goals should be defined and used as a basis for initiating and implementing an EBR system (project approach)
  • What an automation pyramid is and what models and/or standards are applicable to an EBR system
  • The basic functions and aspects an EBR system must have to ensure compliance with GMP requirements
  • How to analyze and design EBR data models and system concepts
  • The criteria for project planning and validation that must be observed for the transition from conventional paper documentation to electronic documents and records
  • And much more …

You'll also benefit from Roemer's experience and knowledge in project management including how best to prepare for a conversion and valuable advice for building a strong team to manage your conversion.

Converting from paper to electronic systems is always challenging, especially if you are dealing with GMP recordkeeping.

Let an experienced, knowledgeable expert give you assistance, right from the beginning. Order your copy of Electronic Batch Recording and Batch Release for Drugmakers today.

Meet the Author

Markus Roemer is an independent consultant and auditor with Comes Compliance Services in Germany. He has worked as a quality project manager for GMP projects, electronic batch recording systems, quality release management and application development, and auditing for Propack Data GmbH – Rockwell Automation.

He has also served as director of compliance management at Systec & Services and senior validation consultant for Invensys Validation Technologies.

He is a founder and member of IT Pharma Validation Europe and ambassador for Germany, Austria and Switzerland at the International Society of Pharmaceutical Engineering (ISPE).

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PDF Edition

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Table of Contents

  • About the Author
  • Introduction
  • Electronic Batch Recording and Batch Release
  • Strategic Goals and Deployment Possibilities of an EBR System
  • System Types by Extent of Automation
  • And More …

View the entire TOC

Who Will Benefit

  • Executive management
  • Data management and statistics personnel
  • IT managers
  • Manufacturing directors and supervisors
  • Quality managers
  • Auditors
  • Compliance officers
  • Consultants/service providers
  • General/corporate counsel

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