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

2020 Virtual IIoT & Smart Manufacturing Conference – October 27, 2020 – 9 am to 5 pm EST

This one-day virtual event will encompass topics regarding advances in connectivity, automation, and security within the operational context of hybrid manufacturing applications across multiple vertical industries.

To register and for more info: https://isaautomation.isa.org/2020-iiot-smart-manufacturing-conference/

AAMI Virtual Event – Integrating Risk Management into the Product Cycle – October 12-14, 2020

This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA, ANSI/AAMI/ISO 14971 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes. Students will discover how to use regulatory databases to support risk management activities at different stages of the product life cycle, as well as the use of International Product Safety Standards during risk management activities.

For more info: https://store.aami.org/s/lt-event?id=a1Y2E000008CKecUAG

AAMI Virtual Training – Integrating Risk Management into the Product Life Cycle – August 18-20, 2020

This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA, ANSI/AAMI/ISO 14971 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes. Students will discover how to use regulatory databases to support risk management activities at different stages of the product life cycle, as well as the use of International Product Safety Standards during risk management activities.

For more info: https://store.aami.org/s/lt-event?id=a1Y2E000008CKeSUAW

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.

2020 Virtual IIoT & Smart Manufacturing Conference – October 27, 2020 – 9 am to 5 pm EST

AAMI Virtual Event – Integrating Risk Management into the Product Cycle – October 12-14, 2020

AAMI Virtual Training – Integrating Risk Management into the Product Life Cycle – August 18-20, 2020

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.