Executing a Successful Remediation Program
Sponsored by: NSF International
- Quality Management Systems
Date: 10 December
Time: 3PM London/10AM New York
When your company is facing a need for remediation as a result of an actual or even threatened enforcement action by a regulatory agency, there will be a host of different systems and processes that are examined to determine what the best course of action to take.
There are plenty of companies that have successfully transformed their Quality Management Systems through intensive remediation planning and execution, and there are others that have failed to find positive outcomes after sometimes months or even years of effort. A company facing an extensive list of observations at the end of any regulatory inspection may well likely react with great energy and purpose to fix each one only to discover that a reactionary approach can lead to disappointment upon the next follow up inspection when it reveals additional examples of the same or similar problems. This will lead to a repetitive cycle of failures resulting in chronic quality system/GMP non-compliance, which puts an even higher amount of burden for change on the Company.
Join our webinar to learn how a strategic and well planned out remediation effort becomes paramount to long term sustainable corrections, and how NSF uniquely views the process and executes using our industry experience to ensure that when new systems are put in place that they will address what are the sometimes overlooked aspects of remediation, the underlying causes and the support systems that drive actual sustainable change and provide fundamental success factors.
Executive Vice President, Health Sciences Consulting
Jesse Ahrendt is an experienced industry consultant with over 20 years of active engagement in pharmaceuticals, medical devices and biotechnology as a certified Quality Auditor and Quality Engineer. His areas of expertise include QA Compliance, third-party vendor evaluation, cGMP manufacturing, quality systems and quality auditing including CAPA, Investigations, validation, mock inspection, supplier qualification, QMS, risk assessment and procedural updates. Mr. Ahrendt is an accomplished quality assurance and manufacturing improvement innovation leader who optimizes organizational resources. He has spearheaded organizational strategic quality assurance, manufacturing, vendor quality and supply chain operation optimization. Mr. Ahrendt’s work has included activity on most continents and working alongside many cultures creating and executing product and process validations per international compliance requirements. In addition, he has implemented new QMS systems and operational manufacturing programs into existing client portfolios, including the management, training and staff alignment portions of projects and qualification activities for multi-facility and multinational organizations. His background is extensive in continuous quality improvement, cGMPs, management principles, global regulatory guidance, and Lean, Six Sigma and QbD principles.