Preparing for an FDA Inspection
This program will focus on preparing your company for a successful FDA inspection. The course will focus on key GMP and Data Integrity guidelines and can be customized to address on-going data integrity or GMP issues at your facility.
Our dynamic instructors will help your team understand why procedures are in place and what the ramifications to the company can be if Quality procedures are not followed.
This training can be customized to meet your company’s specific needs and would be appropriate for sponsor organizations including pharmaceutical, biotech, and medical device organizations, CMOs, packaging/labeling contractors, analytical laboratories, and warehouse and distribution center personnel.
You can select from our listed topics or we can incorporate other relevant topics that you request.
Examples of 483s, Warning Letters or other official action will be included, as appropriate.