![Monarch Quality Systems Solutions 1](/images/BANNERS/interiores/Monarch-Quality-Systems-Solutions-1.jpg)
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How to implement an effective Root Cause Analysis and CAPA Program; A close loop approach
Course Director: Jackelyn Rodriguez
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![](/images/Courses/Pharma/Best-Practices-for-an-Effective-Quality-Assurance-Auditing-for-FDA.jpg)
Best Practices for an Effective Quality Assurance Auditing for FDA Regulated Industries & ISO13485 -MEDSAP
Course Director: Jackelyn Rodriguez
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How to Prepare for FDA Inspections
This course is designed so that you will:
This course will provide the latest FDA expectations for compliance with Drug and Device GMPs, attendees will learn how to prepare, manage and successfully complete an FDA inspection.
![](/images/Courses/Pharma/How-to-Implement-Risk-Management.jpg)
How to Implement Risk Management Principles and Activities Within a Quality Management System
Course Director: Jackelyn Rodriguez
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An Effective Risk Based Approach to Auditing and Qualifying Suppliers and Vendors
Course Description
Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)
The auditing and qualifying training course includes a process for selection, audit, approval and qualification of vendors/suppliers based on the material/equipment/service being delivered. These decisions must be documented and must be based on the impact (risk) to the final product.
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Computer System Validation – A based risk approach
Course Description
Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)
This computer system validation course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations.