"Laboratory Inspection and Auditing" Seminar has been added to ComplianceOnline.com's offering.
SAN JOSE, CA, USA, March 2, 2021 /EINPresswire.com/ -- ComplianceOnline, the largest GRC Advisory Network, has officially launched registration for the one-day virtual seminar ‘Laboratory Inspection and Auditing.’ The seminar will be delivered by Mark Powell, Director, Mark Powell Scientific Limited and will be held on March 9, 2021 (10:00 AM to 5:00 PM EST).
Quality auditing of pharmaceutical quality control laboratories is an important activity for those performing due diligence or monitoring the performance of a sub-contractor. Besides covering GMP regulations affecting pharmaceutical quality control, this one-day course is designed to provide the non-specialist with the necessary knowledge to understand the quality significance and risk associated with different analytical operations.
By the end of the course, attendees will be able to:
• Identify non-conformance to cGMP regulations in analytical operations
• Understand the key steps in the analytical process
• Recognize commonly-used analytical techniques and instruments
• Appreciate the significance of pharmacopoeias in analytical operations
• Understand the requirements for controlling reference standards, reagents and important consumables
• Appreciate the importance of GMP controls over analytical method suitability (validation, verification and transfer)
• Classify analytical instruments according to quality risk and understand the qualification requirements for each class
• Understand current expectations for data integrity controls, including electronic data systems
• Identify non-conformances in the control of stability studies
• Appreciate the regulatory requirements for reference and retention samples
• US and EU GMPs relating to quality control operations
• Appropriate GMP controls at each step in the analytical process
• Information provided by different analytical techniques
• Pharmacopoeias – contents, structure and regulatory significance
• Significance of ICH guidance
• Quality requirements for reference standards and reagents
• What are critical consumables and how should they be controlled?
• Control of analytical methods over their lifecycle
• Appropriate qualification of analytical instruments
• Data integrity – current expectations
• Control of stability studies
• Requirements for reference and retention samples
Who will Benefit:
• GMP auditors
• Quality assurance professionals
• Laboratory managers
• Quality management
For more information or to register for this seminar, please click here.
Virtual Training Through WebEx
Date: March 8-9, 2021 (10:00 AM to 6:00 PM EST)
About the Speaker:
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.
ComplianceOnline is a leading provider of regulatory compliance training programs for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 55,000 professionals from 15,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California, and can be reached at http://www.complianceonline.com. ComplianceOnline is a MetricStream portal. MetricStream (www.metricstream.com) is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC), and Quality Management Solutions for global corporations.
For more information on ComplianceOnline or to browse through our training programs, please visit our website