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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 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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How to Develop an Effective Complaint Handling and Post Market Surveillance and MDR Program for Devices for Boston


CourseDirector Course Director: Jackelyn Rodriguez

CourseCost Course Cost | Ubicacion1 Course Location |  Date Course Date

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