FDA GMP QSR One Day Workshop in Miami

CORAL GABLES, Fla. - Aug. 5, 2013 - PRLog -- A manufacturing simulation GMP workshop where you will gain practical experience applying FDA QSR guidelines.  

Current Good Manufacturing Practices (cGMPs FDA 21 CFR Part 820) are the regulations that govern medical device/pharm manufacturing for product manufactured in or sold in the United States.

In this one-day, instructor-led, hands-on, training workshop you will:
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 importance of quality system elements such as internal audit, process documentation, quality control and process control on product quality.

This 1-day workshop will provide valuable assistance to FDA regulated companies, such as:
- Start-Ups in Medical Devices
- 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 20, 2013 - Fee: $299.00

Register Now at: http://www.eventbrite.com/event/7742324501  

Workshop Overview
- Overview of the US Food and Drug Administration (FDA) and Quality System Regulations (QSR)
– Management Responsibility
– Audits
– Quality Control
– Record-Keeping and Good Documentation Practices (GDPs)
– 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