One of the ways the FDA confirms compliance with quality regulations is through inspections and audits. The FDA inspects manufacturers of finished medical devices as well as suppliers of components, parts or accessories of devices. 

Warning letters are issued by the FDA if they find a medical device firm or individuals products, practices, processes, or other activities are in violation of the Food, Drug, and Cosmetic Act. The warning letter affords firms the opportunity to voluntarily take corrective action prior to the initiation of formal enforcement action.

In this course participants learn about FDA inspection trends and warning letters relating to recent software validation non-conformances. This is done by the review of warning letters where noncompliance to software validation requirements are cited.

If you want us to cover a particular topic just let us know and we can customize the course for you.

This short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

One of the ways the FDA confirms compliance with quality regulations is through inspections and audits. The FDA inspects manufacturers of finished medical devices as well as suppliers of components, parts or accessories of devices. 

Warning letters are issued by the FDA is they find a medical device firm or individuals products, practices, processes, or other activities are in violation of the Food, Drug, and Cosmetic Act. The warning letter affords firms the opportunity to voluntarily take corrective action prior to the initiation of formal enforcement action.

In this course participants learn about FDA inspection trends and recent warning letters relating to equipment and process validation non-compliances.

If you want us to cover a particular topic just let us know and we can customize the course for you.

Each short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

One of the ways the FDA confirms compliance with quality regulations is through inspections and audits. The FDA inspects manufacturers of finished medical devices and drugs as well as suppliers of components, parts or accessories of devices. 

Warning letters are issued by the FDA is they find a medical device firm or individuals products, practices, processes, or other activities are in violation of the Food, Drug, and Cosmetic Act. The warning letter affords firms the opportunity to voluntarily take corrective action prior to the initiation of formal enforcement action.

In this course participants learn about FDA inspection trends . This is done by the review of warning letters where noncompliance to design control  requirements are cited.

If you want us to cover a particular topic just let us know and we can customize the course for you.

Each short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

One of the ways the FDA confirms compliance with quality regulations is through inspections and audits. The FDA inspects manufacturers of finished medical devices and drugs as well as suppliers of components, parts or accessories of devices. 

Warning letters are issued by the FDA is they find a medical device firm or individuals products, practices, processes, or other activities are in violation of the Food, Drug, and Cosmetic Act. The warning letter affords firms the opportunity to voluntarily take corrective action prior to the initiation of formal enforcement action.

In this course participants learn about recent FDA inspection trends and warning letters. This is done by the review of warning letters where noncompliance to the quality system regulation requirements are cited.

Session is made highly interactive via use of practical examples / case studies. Contact us to request further details on this course.