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.

AAMI Course – Sampling Plans Workshop – February 25, 2021, February 26, 2021, and March 1, 2021 / 1:00 pm – 3:00 pm ET

Sampling a product or process and measuring a quality characteristic is an efficient way to make an inference about the quality of all products or the entire process. Simply put, if it is too expensive to measure everything, then you would be wise to sample and measure a subset. If you decide to sample, then comes the age-old question: “How much should I sample?”

Sampling is a key statistical method used for Design Control, Process Validation, CAPA, complaint monitoring, and for Receiving, In-Process, & Finished Device Acceptance. This workshop will discuss the recommendations of the guidance documents developed by the FDA and the Global Harmonization Task Force (GHTF) along with industry standards. It will also provide best practices applied in a wide variety of industry settings.

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AAMI Course – Integrating Risk Management into the Product Life Cycle – Offered Virtually February 17-19, 2021

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.

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AAMI Course (Offered Virtually) – Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485 – February 8-10, 2021

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.

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