Online Webinar 2019 - 2 Day Seminar : Quality Management System: A modern approach to designing, implementation and maintenance of a QMS

Overview
Quality Management System: A modern approach to designing, implementation and maintenance of a QMS. A course/seminar that will help you create a system that supports business, and will aim in reducing the required cost and resources.
A robust QMS has always been considered the cornerstone of a well-functioning and healthy organization. However, time and again, we realize challenges when implementing, executing, or trying to improve such systems. Internal departmental discussions, jurisdictional arguments, lack of parts of the organization’s fullhearted commitment to quality or the void in empowering the staff’s ownership of compliance and quality in their own daily operations. These are just a few challenges that we all can recognize and have experienced through different means.
The expectations have been there for decades. Most of us in the industry are quite familiar with what the requirements are. Whether it is US FDA, EMA, MHRA, ANVISA, CFDA, etc., as long as they are applicable, we need to comply with them. Still, we are struggling with how to implement these most efficiently. We keep asking ourselves, “How can that be?”. How do we address and overcome these challenges? Is our QMS robust and does it serve its purpose as long as it complies with external requirements, or do we have any internal expectations, or other best practices, that should be formalized and adhered to?
This seminar helps streamlining and formalizing your processes and QMS structure to serve your business and your commercial success. We acknowledge that a QMS does not serve its purpose, if it is not supporting a successful, productive and rewarding commercial operation.
We believe that proactive prevention of failure through initial investment is a much less expensive endeavor than immediate short-term cost savings extended by long-term, reactive, repetitive and costly corrections. Not only this is inefficient waste of resources, it is also discouraging for involved staff and would cause loss of employee loyalty.
Who Should atttend
• Quality Executive Management
• Operations Executive Management
• Quality Managers
• Auditors
• Regulatory Affairs
• Research & Development (R&D) Staff
• Manufacturing Staff (incl. Packaging Labelling)
• Calibration and Preventative Maintenance Staff
• Warehouse Staff
• Archiving Staff (including electronic data storage)
• Compliance Staff
• Outsourcing Staff
• Project Managers
• Validation Specialists
• IT-staff
• Managers / (Senior) Directors of R&D
• Human Resources Department
• Document Management Staff
• Training System Staff
• Suppliers & Service Providers (e.g. Contract Manufacturers (CMOs), Contract Research Organizations (CROs), Computerized System Suppliers, etc.)
Speaker
With more than 19 years of worldwide GxP-experience in Pharmaceutical, Biotech & Medical Device industry, Mr. Amirpour has provided clients and colleagues support that has its main focus at the company’s business interests. His areas of qualification and experience include, but are not limited to: Quality Systems, Management & Organizational Structure, QA/QC, Auditing, Training, Outsourcing/Supplier Management, Manufacturing, Investigations, Inspection Readiness, Remediation, Regulatory Compliance, CAPAs, Change Management, Computerized Systems, Packaging, Labelling, Good Distribution Practices, Clinical and Non-clinical Research & Development, Laboratory, Data Integrity, Qualification & Validation, Risk-Management, Cleaning, Instrumentation, (Preventative) Maintenance, and Calibration. Mr. Amirpour has a Master of Science degree, and he is an ISO-9001, ISO-13485, and IRCA-certified Pharmaceutical QMS Lead Auditor. Specific to the latter, for the past 6 years, he has been a Lead Tutor and trained hundreds of quality professionals as a Pharmaceutical Lead Auditor and helped them through IRCA-certification program. He is fluent in English, Danish, and Farsi, and able to communicate in Swedish, Norwegian, German Azeri, and Turkish. Mr. Amirpour’s multi-cultural background has always been acknowledged an asset, when supporting national or international projects, since the human factor and the cultural differences have a substantial impact on the success of any business endeavour.