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


CourseDirector Course Director: Jackelyn Rodriguez

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


CourseDirector Course Director: Jackelyn Rodriguez

CourseCost Course Cost | Ubicacion1 Course Location | Date Course Date

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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.

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


CourseDirector Course Director: Jackelyn Rodriguez

CourseCost Course Cost | Ubicacion1 Course Location |  Date Course Date

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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.

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*Before registering for any of our courses, read our Cancellation policy and  registration policies and procedures.
*All courses can be taught in Spanish