How to implement an effective Root Cause Analysis and CAPA Program; A close loop approach

 Course Director: Jackelyn Rodriguez

 Course Cost |  Course Location |  Course Date

FDA Inspections: Developing Effective Readiness Strategies

 Course Director: Jackelyn Rodriguez

Best Practices for an Effective Quality Assurance Auditing for FDA Regulated Industries & ISO13485 -MEDSAP

 Course Director: Jackelyn Rodriguez

 Course Cost |  Course Location |  Course Date

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.

How to Implement Risk Management Principles and Activities Within a Quality Management System

 Course Director: Jackelyn Rodriguez

 Course Cost |  Course Location |   Course Date

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.

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.