Conference Description:

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


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Course “Quality Management System: A modern approach to designing, implementation and maintenance of a QMS“ has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

"Each attendee will receive 2-Day workshop materials by the faculty. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS"


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.


The Seminar:
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.


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


Agenda:
Day One
Lecture 1: Introduction and Background
-Introductions / Participants' Understanding / Participants' Objectives for the Course (Please come prepared to discuss)
-Regulatory Focus, and some of the applicable Requirements
Lecture 2: Understanding QMS
- What attributes would apply to a favorable vs. unfavorable QMS
-Functional, Departmental, Internal/External Interfaces
- Quality Metrics
-Continuous Improvement
Lecture 3: Quality Risk Management
- Process Risk Management
-Quality Risk Management
- Risk Register
Lecture 4: The Concept of Quality
- Quality Function
- QA
- QC
-Qualification & Competence


Day Two


Lecture 5: Management Role & Responsibilities
- Corporate Commitment to Quality
Quality Metrics
- Audits & Inspections
- Understanding and Defining Compliance
Lecture 6: Company’s Infrastructure
- Types of Operations
- Geographical locations of operation and marketing
- Company hierarchy and lines of reporting
- Utilized Systems (i.e. automated vs. manual, electronic vs. paper-based)
Lecture 7: QMS Elements
- Complaints
- Deviations and CAPAs
- Training
- Outsourcing
-Audits
- Continuous Improvement
- Change Management
- Computerized System
- Validation
- Facilities & Equipment
- Risk Management
- Supply Chain/Good Distribution Practice
- Data Integrity
Quiz: Multiple Choice
- QMS Test (expected to answer 80% correct)

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.



Please contact the event manager Marilyn ([email protected] ) below for:
- Multiple participant discounts
- Price quotations or visa invitation letters
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