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.
Laboratory equipment qualification, also referred to as analytical instrument qualification (AIQ), is an essential component of good analytical practice. It provides assurance that the instrument will perform accurately and consistently in accordance with specifications and user requirements. The ultimate objective for equipment qualification is the documented and demonstrated assurance that the unit will produce valid data. Qualifications must be performed initially and on an ongoing basis (no less than annually).
Customer feedback is an invaluable tool for measuring the effectiveness of your quality management system. ISO 9001:2008 has made the customer the primary focus of the quality management system, as it is a recurring theme throughout the standard. As such, the standard recognizes the value in using customer feedback to gauge success, and as a tool for continuous quality improvement.
On May 30th, David Exline, Senior V.P. at Gateway Analytical presented a webinar that covered an overview of wear debris characterization for laboratory personnel that evaluate quality issues with medical devices. This webinar focused on the causes of wear debris, the affects of such debris on product quality, acceptable limits and methods for ensuring quality products.
A solid equipment control program is an integral component of any laboratory quality management system. The goal of the equipment control program is to ensure that your equipment is under established controls at all times. Equipment control is an area too lengthy to comprehensively define in a short article, so I’ve included some key points to keep in mind.
On April 25th, 2012 we hosted a live webinar titled “Laboratory Methods for the Examination of Foreign Particulate Matter.” During the webinar our presenters, David Exline, Senior V.P. and Antonio Scatena, Scientist at Gateway Analytical, discussed current methods of particulate isolation, laboratory testing methods for identifying foreign particulates and the company's forensic approach to source determination. During the webinar we received a number of questions, below is a sample of the Q&A session at the end of the webinar.
Method validation is the process of demonstrating that the performance characteristics of an analytical method meet the requirements of the intended use and extended range of interest. Although the parameters may vary depending on the type of the method to be validated, common validation elements that need to be considered are:
I'm excited to say that Gateway Analytical is one step closer to achieving its 2012 goal of ASLCD/LAB accreditation for our forensic trace evidence analysis services. We've submitted the required application materials including the Quality Management System Manual, Statement of Qualifications (SOQs), and Standard Operating Procedures (SOPs), among others, which have been accepted by the assigned assessor and we are now undergoing a document gap analysis. We expect our certification audit to be in May or June and look forward to meeting our goal of ASCLD/LAB accreditation in late Q3 or early Q4!