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

Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – November 2-6, 2020

This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International Organization for Standardization (ISO) standards development teams. Participants will learn how to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and ANSI/AAMI/ISO 13485:2016.

For more info and registration info:  https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y2E000008CKeI

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