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.
An Effective Risk Based Approach to Auditing and Qualifying Suppliers and Vendors
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 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.
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.
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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- How to Develop an Effective Complaint Handling and Post Market Surveillance and MDR Program for Devices
- Medical Device