Focus Compliance & Validation Services2018-08-02T21:30:57+00:00
Welcome to Focus Compliance & Validation Services
Core Regulatory Compliance & Validation Services
Focus Compliance & Validation Services provides consulting services to assist our clients in achieving and maintaining FDA regulatory compliance. Our core areas of expertise include: computer system validation; quality system development, implementation, maintenance, and auditing; response to agency actions including 483s and warning letters; FDA mock inspections and mock recalls; training; risk management; process validation and equipment qualification; and related assistance. We have experience providing these services in the medical device, pharmaceutical, and biotech industries.
Computer Systems Validation
Medical Device Industry
Pharmaceutical Industry
Regulatory Affairs/GXP Compliance
Blood and Plasma Industry
Pharmaceutical Packaging Industry
Focus Compliance & Validation Services is located at 4700 Papermill Drive in Knoxville, Tennessee.

AAMI Online Event – Valid Statistical Procedures for Process Validation – Made Easy – September 28-29, 2022

A big challenge for Process Validation is to establish objective evidence that a process is capable of consistently delivering quality product. The goal of these two webinars is demonstrate how valid statistical techniques meet this challenge – and better yet, save time, money and resources.

The application of valid statistical techniques is encouraged by the FDA’s Quality System Regulation, the FDA’s cGMP for Finished Pharmaceuticals, and ISO Standard 13485 for Medical Devices. The content reinforces the topics covered in the Process Validation Guidance document endorsed by the Global Harmonization Task Force (GHTF). Emphasis will be placed on best practices for quality systems in industry.

For more information:

AAMI – Understanding TIR45: Agile Methods for Medical Device Development – September 21, 23, 29, and 30, 2022 – 1:00 pm – 3:00 pm ET

This two-part, four-session series begins with an introduction to AAMI TIR45, Guidance on the Use of AGILE Practices in the Development of Medical Device Software, and then addresses many of the key concepts and recommendations provided by TIR45. With a combination of slides (using Key Takeaways and Diagrams from TIR45) and dialogue with the audience, we will explore the general recommendations from TIR45 and apply them to the practical, real-world constraints of a medical device development organization. Attendees will learn how to read TIR45 so it can be used as a reference after the course, as well as learn concepts that will help break down the barriers their organizations face in the application of Agile methods. Attendees will leave with a better understanding of how Agile methods can and should be used in the development of medical device software and systems.

For more information:

AAMI Virtual Course – Medical Device Cybersecurity 101 for HTM Professionals – September 13-15, 2022

Today the news is inundated with stories about cybersecurity compromised businesses, public services, and government operations.  Among those we often hear as being compromised are hospitals and healthcare-related organizations.  When compromises to healthcare organizations do occur, they have frequently shut down a department’s or an entire organization’s operations so that their ability to deliver healthcare and even patient safety can be adversely affected in a severe way.

For more information: