This GMP workshop alternates classroom learning with a realistic factory simulation. Participants are taken through several rounds evaluating and implementing corrections to gain practical experience applying FDA QSR guidelines.
Current Good Manufacturing Practices (cGMPs FDA 21 CFR Part 820) are the regulations that govern medical device manufacturing for products manufactured in or sold in the United States.
One-day, instructor-led, hands-on, training workshop:
- Learn how FDA regulations apply to all aspects of your medical device business.
- Understand the requirements of a quality system and how to identify potential gaps within a quality system.
- Recognize the importance of internal audits, process documentation, quality control and process control on product quality.
Workshop Topic Overview:
- US Food and Drug Administration (FDA) and Quality System Regulations (QSR) Overview
- Management Responsibility
- Quality Control
- Supplier Controls
- Identification and traceability
- Acceptance activities for materials
- Labeling, storage, distribution and installation
- How to manage production and process changes
- Non-conforming products: how to address them
- Corrective and Preventive Actions (CAPA)
- Design Controls
FDA-regulated companies will gain valuable experience, such as:
- Companies looking to expand sales to the USA
- Companies with external audit concerns/findings
- Medical Equipment service providers & distributors
- Anyone involved in regulatory audits
REGISTER TODAY FOR THIS PRACTICAL PROGRAM
August 2, 2012 - Fee: $97
Register Now at: http://events.r20.constantcontact.com/