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.

Manufacturing Leadership Development Series – Module 3: Coaching and Mentoring – September 17, 2019 – 9 am to 12 noon ET

Coaching and mentoring comes in multiple forms and both are critical to the success of strengthening
your team and building a solid succession plan for key leaders. This module defines and explains how to
coach and mentor, how to set appropriate goals and coaching to achieve those goals, how to overcome
common obstacles and develop a coaching plan and provide feedback.

For more info:

The Quality System Regulation 21 CFR 280 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – September 2019

This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices­­-Application of Risk Management to Medical Devices.

For more info and registration:

Workforce Development Conference 2019 – September 18

Leaders of business and industry, local chambers, workforce and economic development agencies, and Tennessee’s higher education community are all hard at work to constantly strengthen our state’s workforce preparedness and close skills gaps.

We hope you will join us to learn and share your thoughts/opinions on the future direction of education and workforce policies and best practices.


Session topics include:

  • High School Dual-Enrollment Credentialing
  • State Perspective/Collaboration from the Top: Commissioner Penny Schwinn | Mike Krause | Commissioner Jeff McCord
  • CAPS Program
  • TBR Update: Dr. Flora Tydings
  • Comprehensive Workforce Updates: TN Higher Education & TN Board of Regents
  • Overview of Military Transition into Tennessee Workforce
  • Governor Bill Lee (Invited)

For more info and registration: