Call us today at 865.694.7517 | Email: Focus@FocusCVS.com
Focus Compliance & Validation Services2018-08-02T21:30:57+00:00
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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

AAMI Virtual Course – Process Validation Requirements & Industry Practices – April 8 – 10, 2026

This 3-day virtual course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System Regulation and recognized process validation guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. Topics include planning, protocol development, validation execution, monitoring & control and re-validation to meet the FDA’s expectations and the industry’s best practices.

For more information:  https://aami.org/event/process-validation-requirements-industry-practices-april26/

World Medical Device Standards Congress – April 13 – 14, 2026 in Leesburg, VA

The medical device/technology standards environment is a sprawling network of stakeholders whose shared goal is to write standards that advance patient safety and ultimately public health. International standards development organizations (SDOs) conduct their work with strict attention to transparency, precision and care; however, medical device standards do not always meet their intended promise because they often do not take all stakeholders’ needs into consideration.

The World Medical Device Standards Congress is an invitation-only event that will bring together key leaders across medical device/technology standards committees, industry, regulators and SDOs to discuss how to optimize standards and put them to work more effectively on behalf of regulatory science and medical device safety and performance. The intention is to enhance communication and cooperation across our community and increase the usability and impact of medical device standards.

For more info:  https://aami.org/event/world-medical-device-standards-congress/

AAMI Course – Design Control Requirements – Integrating the QMSR – October 6 – 9, 2025 – Dublin, Ireland

This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.

For more information:  https://aami.org/event/design-control-requirements-integrating-the-qmsr-dublin-ire-oct-2025/