Preparing for Regulatory Inspections

October 28, 2013
Patricia Van Arnum
Pharmaceutical Technology

Regulatory compliance is of paramount importance to pharmaceutical and biopharmaceutical companies, which 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).

Regulatory compliance is of paramount importance to pharmaceutical and biopharmaceutical companies, which 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). Pharmaceutical Technology will present an educational webcast on Thursday Nov. 7th from 1:00 to 2:00 PM EST, “Ensuring Preparedness for Regulatory Inspections,” which will provide insight on inspection trends and practical advice on how to best prepare for GCP/GMP inspections, examine the key information/documentation sought by regulators, and ways to achieve operational efficiency for providing access to that information.

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 technology can better prepare companies for successful GCP/GMP inspections.

The panelists for the webcast will be: Robert Schiff, PhD, RAC, CQA, FRAPS, President and CEO, of Schiff & Company; Steven Scribner, Principal Consultant,
Documentum for Life Sciences, EMC Corporation; and Adam Kelch, Product Manager, Documentum for Life Sciences, EMC Corporation. Viewers can ask questions of the panelists to gain further insight into how to meet regulators’ expectations and requirements for successful GCP/GMP inspections and how to optimize laboratory, manufacturing, and quality systems  to provide efficient access for related documentation and information to ensure successful inspections.

Additional information and to register for the Pharmaceutical Technology webcast, “Ensuring Preparedness for Regulatory Inspections,” for Thursday Nov. 7th from 1:00 to 2:00 PM EST may be found here.