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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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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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Auditing for Medical Devices: EN ISO 13485:2016 How to implement Changes

Course Description - Course runs 9:00am - 5:00pm (Breakfast & Lunch Included)
This continually updated course covers the changes to compliance requirements with respect to managing a medical device quality system.

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Overview Of FDA Regulatory Compliance For Medical Devices

Who Should Attend
This course was developed for those who are involved with ensuring regulatory compliance for medical devices. This course is designed for individuals who require in-depth knowledge of regulatory affairs and compliance issues.

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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