QA Edge, Inc. provides the resources and expertise to solve 21 CFR Part 11 problems throughout FDA-regulated industries. Our initial Part 11 services include On-site Training and Compliance Assessments. Take the first step and Contact Us for additional information about how you can obtain FREE, on-site training for your staff.
On-site Training
Did you know that you can have Part 11 training at your site for FREE?
Yes, executive trainers from QA Edge, Inc. will deliver the following program at your site as a way to introduce you to the services of our company:
9:00am-12:00pm - Formal Training
Background
Regulatory Requirements
Part 11 & Computer Validation
Regulatory Activity
483's and Warning Letters
Part 11 Compliance Strategy
1:00pm-3:00pm - Q & APeriod
Breakout Discussion (for optional attendees) on Specific Part 11 Compliance Questions
Cost: First training session is FREE. If outside the Philadelphia area, travel expenses will be charged.
Guarantee: You must be completely satisfied with the training or you pay nothing for travel.
Deliverables: Copy of training slides plus a certificate for each attendee.
Contact Us for additional information and to schedule a time convenient for your staff.
Compliance Assessment
QA Edge, Inc. will formulate a strategy for compliance throughout your organization which includes procedures and tools for inventory and assessment. QA Edge, Inc. will execute a strategy and/or perform Part 11 assessment training to a select group of internal assessors. Our team is focused on providing realistic assessments which are sorted by business/regulatory criticality. Most of all, we focus on delivering assessment results on-time and with minimal disruption to your organization.
First Step to Solving Part 11 Problems: