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

By: Mr. Amirpour, ISO-9001, ISO-13485, and IRCA-certified Pharmaceutical QMS Lead Auditor.
Product code: SEM58
Location 1: Boston Apr 04 - 05

Description

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"

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.

Areas Covered

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 will Benefit

•        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.)

Learning Objectives

Pharma , Medical Device & Biotech 

Course Outline:

(8:30 AM – 4:30 PM)

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

 

(08:30 AM to 04:30 PM)

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)

 

speaker

Mr. AmirpourISO-9001, ISO-13485, and IRCA-certified Pharmaceutical QMS Lead Auditor

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.

04-April-2019 To 05-April-2019 Boston
Seminar One Registration
$ 1296 Early Bird Fee(Before 4 March,2019)



Special Group Discount Register for Four attendees
$ 4796

Please call any of our customer support on 844-267-7299 to avail the below discount for your Group

2 Attendees - 5% off

3 to 6 Attendees - 10% off

7 to 10 Attendees - 15% off

10+ Attendees - 20% 0ff

Other Modes of Payment

Want to register by Wire Transfer?
Please call any of our customer support on 844-267-7299 to help you completed the transfer.

Want to register by check or PO?
Please call any of our customer support on 844-267-7299 or drop any email to help you completed the purchase.

Download Registration Form

Yes, I want to attend this Seminar

Click here to Download Registration Form

Venue to be announced shortly Boston

 

How to Reach

Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer
 

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.

 

“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals

 

“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.

 

“Great session. I learned a lot” Chief HR Professional"

“Wow!  I had an opportunity to attend the HR audit workshop.  It is spectacular and I found it very valuable.
It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

“I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor

“The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes
 and will help us assess the organization’s culture and values.” A Chief Internal Auditor

“I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.
This session and ELLA seems to really fit the bill for us.” A human resource manager

 

Media Partners

Top Media Partners and Sponsors World Compliance Seminars WCS


speaker

Morf Media, Inc. is shaping the future of enterprise compliance training for the mobile workforce. For the first time, a digital compliance training system, Morf Learning™, provides one to one training to millions on a smart phone or tablet. Now in pilot with more than 100 major companies in the financial services and life sciences industries, Morf Learning is proving to be cost-effective and engaging. Morf Learning delivers three-minute mini lessons with a personalized Virtual Coach™ developed using the Octalysis framework designed by world-renowned gamification leader, Yu-Kai Chou. 


speaker

Benefits of enrolling for Media Partner

Your company Logo on all the mailings before and after the event.

Get 10% discount to media partner's subscribers.

Publish your Logo and company data on the event website.

Publish your Logo on the conference material distributed during the conference.

Media Partner’s brochure distributed along with conference material


speaker

MEDIA PARTNERS WORK TO DO

Publish Banner on the Media Partner website.

Insertion of the WCS event in the event calendar, both printed and/or online.

Announcement article of the conference on the Magazine and/or Website.

Dedicated email blast to all subscribers

Sponsors

Top Sponsors for WCS - World Compliance Seminars


speaker

If you wish to sponsor our event

Please contact us: 

partner@worldcomplianceseminars.com or speak with one of the account manager + 844 267-7299


speaker

$2,000 - Silver Sponsor Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases 

Listing in monthly Community Leader newsletter sent to over 50,000 users. 

1 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees


speaker

$4,000 - Silver Gold Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases 

Listing in monthly Community Leader newsletter sent to over 50,000 users. 

2 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees

15-20 minutes product demo during the live session

Freedom Trail, Boston

The three-mile Freedom Trail leads you past - and into - 16 of the city's principal historic monuments and sites. It's easy to follow, by the line of red bricks in the sidewalk and by footp

Fenway Park, Boston

Known as "America's Most Beloved Ballpark", Fenway Park is one of the most fabled sports complexes in the country, and even if you're not a sports fan, a tour of it is both fun an

Museum of Science, Boston

Exhibits in this extensive science museum encourage learning through hands-on exploration of science and technology, but the museum is not just for children. Physics, biology, chemistry, ecology, z

Harvard Square and Harvard Art Museums, Boston

Harvard University, founded in 1636, is the oldest institution of higher learning in the United States and is widely considered one of the world's leading academic centers. Go

Harvard Museums and the Glass Flowers, Boston

Although the four museums that make up this complex contain treasures such as the artifacts brought back by Lewis and Clark, for most people, the highlight is the more than 3,000 models of 830 spec

Back to Top