Quality Management System 2019 - 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.
Our objective for this program is to:
- Help you assess the status of your current system
- Identify your expectations of a well-functioning QMS, based on your organization’s needs
- Help you make a GAP-analysis to identify what is required for your system to fulfill your expectations
- Provide you with the necessary tools to revise the system in accordance with identified pathway
- Provide you with the expected elements required to maintain and improve the system throughout its life-cycle
The topics that are going to be covered in this seminar include, but are not limited to:
- Management’s Role and Responsibilities
- The Company’s Quality Structure, Including Quality Assurance (QA) and Quality Control (QC) Functions
- Customer Satisfaction / Complaints
- Deviations and Corrective and Preventive Actions (CAPAs)
- Training
- Subcontracting and Supplier Management
- Internal and External Audits
- Continuous Improvement
- Change Management
- Computerized System
- Validation
- Facilities & Equipment
- Risk Management
- Supply Chain/Good Distribution Practice
- Data Integrity
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