Full Day work Shop on FDA cGMPs from A-Z by Lean Compliance partners:
Course Objectives:
Provide participants with understanding of the FDA�s Quality System Regulations (current Good Manufacturing Practices, 21CFR820), and how it applies to their everyday activities. Focus is on business processes starting with Supplier Controls and Receiving Inspection through to Packaging and Shipping. From the start, participants partake in hands-on exercises that are carried through the entire workshop, illustrating real-world impact cGMPs have on every part of an FDA-regulated business.
Contents Overview:
Overview of the US Food and Drug Administration (FDA) & Quality System Regulations (QSR)
General provisions of current Good Manufacturing Practice
General provisions of current Good Manufacturing Practice
Record-Keeping and Good Documentation Practices (GDPs)
Supplier Controls
Identification and traceability
Acceptance activities for materials
Quality Control
Audits
How to manage production and process changes
Non-conforming products: how to address them
Corrective and Preventive Actions (CAPA)
Labeling, storage, distribution and installation
Benefits of Training:
Through this 1-day hands-on workshop, participants will work through exercises to demonstrate how cGMPs, following FDA 21 CFR Part 820, apply to all aspects of their business. Upon completion, participants will be able to understand the requirements of a quality system and how to identify potential gaps within one.
Workshop Exercises:
Exercise - Spot the GDP Errors: Attendees will identify GDP errors and correct them independently, followed by in-class review and Q&A.
Exercise - Receiving Inspection: Exercise completed in pairs where attendees will simulate receiving inspection process in a non-GMP environment. Attendees will
identify the errors in the process and recommend corrections.
Exercise - Quality Car manufacturing controls: Simulation assembling quality cars in a non-GMP environment. Attendees will identify the errors in the process and
recommend corrections.
Exercise - Quality Car Manufacturing Validation Requirements: Group exercises to identify processes in quality car manufacturing that require validation or not, and why
Who Should Attend:
This 1-day workshop will provide valuable assistance to FDA regulated companies, such as:
Start-Ups and established companies in Medical Devices or Pharma Companies looking to expand sales to the USA Companies with external audit concerns/findings
Medical Equipment service providers & distributors
Anyone looking to identify potential gaps in their quality system Management or Personnel representatives from:
Executive Management
Quality and Compliance
Manufacturing and Operations personnel
Any employee involved in regulatory audits
About the Trainers/Speakers:
Cynthia Juncosa and Myriam Ochart are co-founders of Lean Compliance Partners, a consulting firm dedicated to working with FDA-regulated start-ups, growing and established business to their growth and competitiveness in local and global markets.
Cynthia�s extensive training and practical experience in lean six sigma, operations management, social media and quality initiatives, and over 14 years of experience in the FDA-regulated industry gives her an appreciation for the challenges facing businesses today. Cynthia is passionate about employee training and development � it is the foundation for success of any business. Cynthia is a PMI certified project management (PMP) and ASQ certified Six Sigma Black Belt (CSSBB). She serves on the board of the Florida Speakers Association (FSA) for 2012-2013, and is an active member of the American Society for Quality (ASQ), Project Management Institute (PMI) and American Society for Training & Development.
Myriam has been consulting since 2007 providing consulting, process improvement, ISO implementation and Training. Myriam was one of six Six Sigma Black Belts working for global
bank: ABN AMRO. Her extensive training and practical experience in transactional six sigma, lean six sigma, operations management and quality initiatives and acquired experience in
multiple industries provides her in-depth knowledge of the challenges facing businesses today. Myriam is an ASQ certified Six Sigma Black Belt (CSSBB) and certified Manager of
Quality/Organizational Excellence (CMQ/OE). She has been on the ASQ national Voice of the Customer Committee for the last 5 years and currently chairs the ASQ Community Outreach
Committee. She is an active member of the American Society for Quality (ASQ) and American Society for Training & Development
Conference Secretariat: QA, QC and Validation OMICS Group Conferences
5716 Corsa Ave., Suite 110, Westlake, Los Angeles, CA 91362-7354, USA
Phone: +1-650-268-9744 l Fax: +1-650-618-1414
Toll free: 1-800-216-6499(USA & Canada) l 1-800-651-097(Australia) E-mail:qualitycontrol2012@omicsonline.com
The Organizers reserve the rights to make changes and adjustment to the information in this website Copyright� 2008-2012OMICS Group - All rights reserved
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