Focus Compliance & Validation Services

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Pharmaceutical Industry
Focus provides proven solutions to the FDA Regulated Pharmaceutical and Biotechnology Industries.
Consulting Services to the Pharmaceutical Packaging Industry
Focus Compliance & Validation Services provides engineering and consulting services to primary and contract pharmaceutical packaging companies. These services include the implementation of systems, procedures, and documentation to meet the FDA Quality System regulations affecting the packaging industry.
Computer Systems Validation
The FDA and other regulatory agencies have established criteria for software-based applications developed for use within the pharmaceutical, biological, and medical device industries. Focus personnel have experience with computer systems validation activities and provide services for a full range of validation deliverables, from Validation Plans through Validation Summary Reports.
Consulting Services to the Medical Device Industry
Focus Compliance & Validation Services provides engineering and consulting services to primary and contract medical device companies.
Regulatory Affairs and GXP Compliance
Focus provides innovative solutions to the FDA regulated industries. Our regulatory compliance specialists work closely with the FDA to ensure our clients have the latest information available and can quickly assess the impact of regulations.
Consulting Services to the Blood and Plasma Industry
Focus Compliance & Validation Services provides engineering and consulting services to the human blood and plasma collection industry. These services include the implementation of systems, procedures, and documentation to meet the FDA Quality System regulations affecting the blood and plasma industry.

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.

OUR SERVICES

Computer Systems Validation

Medical Device Industry

Pharmaceutical Industry

Regulatory Affairs/GXP Compliance

Blood and Plasma Industry

Pharmaceutical Packaging Industry

CONTACT FOCUS CVS

OUR LOCATION

Focus Compliance & Validation Services is located at 4700 Papermill Drive in Knoxville, Tennessee.

NEWS AND EVENTS

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: http://tnchamber.chambermaster.com/events/details/mfg-leadership-development-7-module-series-knoxville-09-10-2019-2451

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: https://my.aami.org/store/events/registration.aspx?event=QS0919

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: http://tnchamber.chambermaster.com/events/details/workforce-development-conference-nissan-training-center-sept-18-2422

Pharmaceutical IndustryFocus provides proven solutions to the FDA Regulated Pharmaceutical and Biotechnology Industries.

Consulting Services to the Medical Device IndustryFocus Compliance & Validation Services provides engineering and consulting services to primary and contract medical device companies.

Regulatory Affairs and GXP ComplianceFocus provides innovative solutions to the FDA regulated industries. Our regulatory compliance specialists work closely with the FDA to ensure our clients have the latest information available and can quickly assess the impact of regulations.

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

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

Workforce Development Conference 2019 – September 18

Pharmaceutical Industry
Focus provides proven solutions to the FDA Regulated Pharmaceutical and Biotechnology Industries.

Consulting Services to the Medical Device Industry
Focus Compliance & Validation Services provides engineering and consulting services to primary and contract medical device companies.

Regulatory Affairs and GXP Compliance
Focus provides innovative solutions to the FDA regulated industries. Our regulatory compliance specialists work closely with the FDA to ensure our clients have the latest information available and can quickly assess the impact of regulations.