Ensuring Preparedness for Regulatory Inspections
Event Date: November 07, 2013 at 01:00 PM EST
Regulatory compliance is of paramount importance to pharmaceutical and biopharmaceutical companies, who must be continually prepared for inspections by FDA, EMA, and other health authorities to meet requirements for good clinical practices (GCP) and good manufacturing practices (GMP). Successful GCP/GMP inspections can be achieved only through well-controlled laboratory, manufacturing, and quality systems with efficient access to related documentation and information. Often, technical limitations in content-management systems result in unsuccessful inspections. This 60-minute webcast will examine the approaches taken by regulatory authorities in GCP/GMP inspections and how properly executed document-management systems and advances in electronic data-management system (EMD) technology can better prepare companies for successful GCP/GMP inspections.


Key Learning Objectives:
1. Understand FDA, EMA, and other regulatory agencies' approach to inspections and how to optimize GCP/GMP content-management systems to achieve successful inspections.

2. Gain insight into the approach regulatory inspectors prefer for content management in electronic trial-master file systems and quality and manufacturing systems.

3. Explore emerging technologies and user interfaces to ensure that auditors have a seamless experience and are securely granted access to the right information.


Moderator

Patricia Van Arnum

Executive Editor
Pharmaceutical Technology

Speakers:

Robert Schiff, PhD, RAC, CQA, FRAPS

President and CEO
Schiff & Company

Adam Kelch
Product Manager – Documentum for Life Sciences
EMC Corporation

Steven Scribner
Principal Consultant – Documentum for Life Sciences
EMC Corporation



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How prepared do you feel for unannounced visits from the regulatory agencies?*Extremely prepared –We’re always fully ready and in complete compliance
Prepared – We can provide access and are reasonably confident we’re in compliance
Somewhat Prepared – We would prefer some advance notice
Not Prepared – We would be at serious risk if subject to an unannounced audit
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What system limitations would currently prevent a smooth audit? Choose all that apply…*Inability to quickly and easily retrieve requested documentation
Difficulty synchronizing documentation with outside partners
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