Conference: IFPAC - 2013 27th International Forum and Exhibition Process Analytical Technology
Location: Baltimore, Maryland, U.S.A.
Date: Wednesday, January 23rd during the PM VIII Session
Time: 1 – 5 pm
FDA Critical Path Opportunity
By definition, management review is a formal meeting of top management with the purpose of reviewing and evaluating the effectiveness of the quality management system. Yes, I know, it sounds like another humdrum status report meeting. And unfortunately, that is the way it is viewed and conducted by many organizations. Management review is too often regarded as something to check off the list in order to satisfy a standard or an auditor. I must admit, when I first started holding management reviews, I shared that view. I would diligently set my agenda to include all of the required items; then I would simply steamroll through them. I’d write my report, file it away, and then proudly present it to the next auditor to examine. As a result, nothing was really gained and much valuable time was lost.
Recently on December 22nd, Dave Exline, Senior V.P. at Gateway Analytical stopped by the Pittsburgh Technology Council’s TechVibe Radio to talk on-air with Audrey Russo and Jonathan Kersting about Gateway Analytical and its services.
One Monday morning in November, an FDA Inspector visited Gateway to perform an inspection. Although we are FDA registered, it came as a complete surprise. It is times like these when you realize how important it is to have a quality management system that is designed to be ‘audit-ready’ at all times. Implementing checks and double checks of all systems (e.g. training, calibration, CAPA, document control, etc.) is crucial for ensuring everything is kept up-to-date per internal procedures and regulatory requirements.
White Paper Preview:
White Paper Preview:
Presented at: Drug Delivery to the Lung 23
Authors: O Olkhovyk 1, R Priore 1, C Vernall 2, R Price 2 and J Shur 2
1.Gateway Analytical, 2.University of Bath
Release Date: Wed., December 5, 2012
On November 14th, Dave Exline, Senior V.P. and Rebekah Wagurak, Forensic Scientist at Gateway Analytical hosted a webinar designed for laboratory and manufacturing personnel that are responsible for quality assurance and quality control of processes in the manufacturing of pharmaceuticals. This webinar discussed case studies and walked participants through the process of a failure analysis investigation, common methods used, and interpretation of analytical data to improve overall process development and quality control.
Poster Title: Assessment of Drugs and Carrier PSD in a Commercial Combinational Dry Powder Inhaler Post Multistage Cascade Impaction Analysis by Raman Imaging
Date: Wed., December 5, 2012
Time: 3:30 pm - 5:00 pm
